Innovative Central Line Securement Device in the Pediatric Population

Innovative Central Line Securement Device: Line Complications and Quality of Life in the Pediatric Population as Compared to Traditional Securement Device

This study involves evaluating pediatric patients with central lines to determine differences in line complications and quality of life in those with a novel central line securement device (wrap) as compared to those who use a traditional securement device (dressing).

Study Overview

• Status: Terminated
• Conditions: Quality of Life; Pediatric Disorder; Central Line Complication; Short Gut Syndrome; Central Line Infection; Central Line-Associated Infection; Central Line Sepsis
• Intervention / Treatment: Device: Wearable Central Line Securement Device (Vest); Other: Traditional Securement Dressing

Detailed Description

Children with central lines experience line breaks, line dislodgment's and line infections as a result of traditional securement techniques (dressings). These issues lead to the patients' increased health care utilization and possibly to restriction of movement and delayed development as the children are restricted in their home environment. The purpose of this study is to determine if a wearable central line securement device, can decrease the number of line breaks, line dislodgment and line infections as compared to traditional securement techniques. Events per month would be calculated for each arm before and after intervention and analyzed for treatment effect. The hypothesis is that the use of this wearable central line securement device can reduce line breaks, line dislodgment and line infections as compared to the traditional adhesive dressing. A secondary outcome for evaluation will be quality of life. This will be analyzed with a standardized quality of life survey and treatment effect will be reported as an ordinal odds ratio. Children are naturally active, however their activity is restricted by the parents given the delicate nature of their line. This study looks to see if quality of life can be improved a more secure wearable attachment device, as compared to traditional securement techniques.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • UPMC Children's Hospital of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with a central line ages 0-18 years old who have never worn a wearable central line securement device (vest) will be eligible for the study.

Exclusion Criteria:

• Those children who currently wear a central line securement device (vest)
• Children with central lines who are 19 years or older
• Those females with central lines and Tanner 2 breast or greater breast development as a wearable central line securement device (vest) will not fit properly to secure the central line and may increase the risk of the central line complications.
• If the patient does develop breast during the time of the study then the patient will no longer wear the wrap and will go back to securing their device in the traditional way. The investgators will still collect data on that patient and they will be evaluated in the device arm consistent with the intention to treat principle.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Device; Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study.	Device: Wearable Central Line Securement Device (Vest); The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects.; Other: Traditional Securement Dressing; All subjects will use sterile dressings throughout the trial as this is the standard of care for central line securement. Subjects randomized to the dressing arm will continue to use standard of care sterile dressing as the only form of central line securement.
Active Comparator: Traditional Securement Dressing; Those is the non-device arm will continue to wear a traditional central line securement dressing as is the standard of care.	Other: Traditional Securement Dressing; All subjects will use sterile dressings throughout the trial as this is the standard of care for central line securement. Subjects randomized to the dressing arm will continue to use standard of care sterile dressing as the only form of central line securement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Outcome - Line Breaks	Number of line breaks defined as any mechanical trauma to the line that required repair but not replacement of the line.	For a maximum of 1 year from enrollment
Primary Outcome - Line Replacement	Number of line replacements in which a line was removed from the patient and a new line was placed.	For a maximum of 1 year from enrollment
Primary Outcome - Line Infections	Number of line infections defined as a positive blood culture drawn from a central line.	For a maximum of 1 year from enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
How Has the Vest or Dressing Affected Your Ability as a Family to Participate in Daily Activities?	Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.	Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
How Has the Vest or Dressing Affected Your Child's Ability to be Active?	Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.	Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses for an individual was 5 over a 12 month period.
How Has the Vest or Dressing Affected Your Child's Ability to Participate in Typical Activities With Peers or Siblings?	Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.	Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
How Has the Vest or Dressing Affected Your Ability to Keep Your Child's Central Line Safe?	Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better and 6 being non applicable. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.	Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
Have You Been Worried About the Safety of Your Child's Central Line?	Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.	Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
Has Your Child Been Able to Take a Long Walk or Play?	Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.	Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
Has Your Child Been Able to Take a Short Walk Outside of the House?	Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.	Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
Are You Worried About Your Child's Current Health?	Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.	Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
Has Your Child Needed to Stay in Bed or a Chair During the Day?	Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.	Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
Has Your Child Needed Help With Eating, Dressing, Washing or Using the Toilet?	Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.	Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
Is Your Child Able to Socialize?	Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.	Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
Is Your Child Able to do Sports/Exercise?	Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.	Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
Is Your Child Able to Attend School/Pre-school?	Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.	Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
Does Having a Central Line Affect His/Her Participation in School?	Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.	Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
Does Having a Central Line Affect His or Her Learning at School?	Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.	Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
Is Your Child Able to Take Part in Hobbies or Leisure Activities?	Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.	Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
Is Your Child Able to Feel Independent?	Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.	Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
Has the Vest or Dressing Been Easy to Use?	Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.	Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
Has the Vest or Dressing Been Comfortable to Wear?	Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.	Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
Has the Vest or Dressing Kept You Child's Central Line Safe?	Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.	Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
Has the Vest or Dressing Prevented Your Child From Tampering With or Touching the Central Line?	Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.	Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
Has the Vest or Dressing Enabled Your Child to be More Active?	Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.	Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
Has the Presence of a Central Line Affected Their Body Image?	Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.	Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
How Would You Rate Your Child's Quality of Life on a Scale of 1 to 10?	Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-10 with 1 being very bad, 10 being very good. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.	Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
How Would You Rate Your Child's Ability to Cope With Day to Day Activities?	Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from -5 to 5 with -5 being very bad, 5 being very well. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.	Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
How Has Your Child's Quality-of-life Been Affected by Vest or Dressing?	Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from -5 to 5 with -5 being very bad, 5 being very well. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.	Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
How Has Your Child's Quality-of-life Been Affected by Their Underlying Illness?	Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from -5 to 5 with -5 being very bad, 5 being very well. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.	Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.

Collaborators and Investigators

• Sponsor: Ryan St. Pierre-Hetz
• Investigators: Principal Investigator: Angelica Mazzarini, MD, UPMC Children's Hospital of Pittsburgh

Publications and helpful links

General Publications

• Ullman AJ, Marsh N, Mihala G, Cooke M, Rickard CM. Complications of Central Venous Access Devices: A Systematic Review. Pediatrics. 2015 Nov;136(5):e1331-44. doi: 10.1542/peds.2015-1507. Epub 2015 Oct 12.
• Burckhardt CS, Anderson KL. The Quality of Life Scale (QOLS): reliability, validity, and utilization. Health Qual Life Outcomes. 2003 Oct 23;1:60. doi: 10.1186/1477-7525-1-60.
• Hwang FR, Stavropoulos SW, Shlansky-Goldberg RD, Mondschein JI, Patel AA, Solomon JA, Itkin M, Soulen MC, Chittams JL, Trerotola SO. Tunneled infusion catheter breakage: frequency and repair kit outcomes. J Vasc Interv Radiol. 2008 Feb;19(2 Pt 1):201-6. doi: 10.1016/j.jvir.2007.08.030.
• Lundgren IS, Zhou C, Malone FR, McAfee NG, Gantt S, Zerr DM. Central venous catheter repair is associated with an increased risk of bacteremia and central line-associated bloodstream infection in pediatric patients. Pediatr Infect Dis J. 2012 Apr;31(4):337-40. doi: 10.1097/INF.0b013e31823eeec5.
• Cesaro S, Corro R, Pelosin A, Gamba P, Zadra N, Fusaro F, Pillon M, Cusinato R, Zampieri C, Magagna L, Cavaliere M, Tridello G, Zanon G, Zanesco L. A prospective survey on incidence and outcome of Broviac/Hickman catheter-related complications in pediatric patients affected by hematological and oncological diseases. Ann Hematol. 2004 Mar;83(3):183-8. doi: 10.1007/s00277-003-0796-9. Epub 2003 Nov 13.
• Peng C, Monagle P, Newall F. Clinical outcomes of management of CVAD occlusions. Arch Dis Child. 2011 Sep;96(9):885-7. doi: 10.1136/adc.2010.194969. Epub 2011 Mar 11.
• Rey C, Alvarez F, De La Rua V, Medina A, Concha A, Diaz JJ, Menendez S, Los Arcos M, Mayordomo-Colunga J. Mechanical complications during central venous cannulations in pediatric patients. Intensive Care Med. 2009 Aug;35(8):1438-43. doi: 10.1007/s00134-009-1534-0. Epub 2009 Jun 16.
• Winkler MF, DiMaria-Ghalili RA, Guenter P, Resnick HE, Robinson L, Lyman B, Ireton-Jones C, Banchik LH, Steiger E. Characteristics of a Cohort of Home Parenteral Nutrition Patients at the Time of Enrollment in the Sustain Registry. JPEN J Parenter Enteral Nutr. 2016 Nov;40(8):1140-1149. doi: 10.1177/0148607115586575. Epub 2015 May 13.
• Gimeno-Santos E, Raste Y, Demeyer H, Louvaris Z, de Jong C, Rabinovich RA, Hopkinson NS, Polkey MI, Vogiatzis I, Tabberer M, Dobbels F, Ivanoff N, de Boer WI, van der Molen T, Kulich K, Serra I, Basagana X, Troosters T, Puhan MA, Karlsson N, Garcia-Aymerich J; PROactive consortium. The PROactive instruments to measure physical activity in patients with chronic obstructive pulmonary disease. Eur Respir J. 2015 Oct;46(4):988-1000. doi: 10.1183/09031936.00183014. Epub 2015 May 28.

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2020
• Primary Completion (Actual): September 15, 2022
• Study Completion (Actual): May 1, 2023

Study Registration Dates

• First Submitted: August 17, 2020
• First Submitted That Met QC Criteria: August 19, 2020
• First Posted (Actual): August 21, 2020

Study Record Updates

• Last Update Posted (Actual): July 5, 2024
• Last Update Submitted That Met QC Criteria: July 1, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Postoperative Complications; Disease Attributes; Gastrointestinal Diseases; Intestinal Diseases; Malabsorption Syndromes; Infections; Communicable Diseases; Short Bowel Syndrome
• Other Study ID Numbers: STUDY19010059

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes