- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03262493
Feeding Tube Attachment Device Versus Conventional Fixation and Its Impact on Accidental Exit of Enteral Feeding Tubes
Use of Feeding Tube Attachment Device Versus Conventional Fixation and Its Impact on Accidental Exit of Enteral Feeding Tubes: Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients will be randomly assigned to the intervention group consisting of the use of the feeding tube attachment device (FTAD) or the control group that will use the conventional method of attachment with micropore adhesive tape and tape . The data will be compared by Student's t test or Mann-Whitney and Pearson's chi-square, according to their distribution. The project was approved by the Ethics and Research Committee of the Hospital de Clínicas de Porto Alegre. Daily will be accessed through the diet map, available in the hospital application, patients who are in use enteral nutrition. These data will be tabulated in the screening worksheet, those who meet the eligibility criteria will be invited to participate in the study and requested the reading and signing of the informed consent by the patient or guardian. The study investigator will inform the allocation group to the guest patient.By means of a structured questionnaire, socio demographic and clinical information will be collected: age, gender, reason for current hospitalization, comorbidities and information related to enteral probe (type of probe, place and date of insertion, number of medications in use via enteral probe, type and the date of the last fixation change).
Traditional fixation with micropore and plaster is routinely performed by the nursing staff every 24 hours or whenever necessary. The procedure will be performed as described in the study protocol (item 1.1).
The feeding tube attachment device (FTAD) contains a layer of hydrocolloid that will attach to the skin and a clamping clamp around the probe. The placement of the catheter fixation device will be performed by the research nurses, these will be previously trained by the manufacturer of the material. The fixing procedure is described in item 1.2.
Patients included will be evaluated daily for study outcomes up to the suspension of enteral nutrition prescription, hospital discharge, death or up to 35 days of follow-up. Patients starting enteral probe use on Saturday and Sunday can be up to 48 hours with the traditional method of fixation and later will be randomized to the intervention or control group.
1.1 Control Group After inclusion in the study, initial evaluation and information to the patient, the attending nurse will follow up on the exchange of the traditional enteral probe fixation device that occurs according to the standard operating protocol in the institution that recommends micropore fixation according to the "tie" technique and exchange Every 24 hours and whenever it is loose or with presence of dirt.
1.2 Intervention Group
After inclusion in the study and the initial evaluation, the patient will be informed of the intervention to be submitted. The care nurse will place the catheter fixation device, which according to the manufacturer, should follow the following instructions:
- Wash the patient's nose with soap and water that does not release residue;
- Rinse vigorously and dry thoroughly.
- Remove the paper that isolates the adhesive barrier (step 1);
- Position the device so that the fastener is approximately 1 cm below the tip of the nose. Apply the barrier to the patient's nose, pressing the barrier surface gently against the skin for 60 seconds (step 2);
- Fasten the feeding probe, closing the clamp around it, and firmly tighten the arms to fully engage the serrated teeth (step 3);
- To remove, raise clamp. Place the tip of one finger over the ledge on the opposite arm and turn the arm to open (step 4).
The exchange of the device should be every 7 days, in the presence of dirt or if material deterioration occurs.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
RIO Grande DO SUL
-
Porto Alegre, RIO Grande DO SUL, Brazil, 90690270
- Michelli Cristina Silva de Assis
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adults hospitalized in the clinic unit care: 6 sul e 7 norte
- Use of enteral nutrition in open system
Exclusion Criteria:
- Use of enteral nutrition by gastrostomy or jejunostomy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Interventional Group
It consists of the use of the feeding tube attachment device (FTAD) to fix the enteral probe.
|
Use of the feeding tube attachment device (FTAD).
|
No Intervention: Conventional Group
It consists of the fixation of the enteral probe with adhesive tape of the micropore type and plaster.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of accidental enteral probes exit per patient
Time Frame: Thirty fifth day
|
Will be accessed by the patient's chart
|
Thirty fifth day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reasons for the accidental enteral probes exit per patient and / or reintegration of enteral probes between the groups
Time Frame: Thirty fifth day
|
Will be accessed by the patient's chart
|
Thirty fifth day
|
Administrated enteral nutrition volume per patient
Time Frame: Thirty fifth day
|
The volume of enteral nutrition received will be accessed by the patient's chart
|
Thirty fifth day
|
Time of fasting or delay in the use of enteral probes between groups
Time Frame: Thirty fifth day
|
Time of fasting will be accessed by the patient's chart
|
Thirty fifth day
|
Collaborators and Investigators
Investigators
- Principal Investigator: Michelli S de Assis, Doctorate, Federal University of Rio Grande do Sul
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 170217
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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