Weekly Versus no Routine Ventilator Circuit Changes in NICU

Weekly Versus no Routine Ventilator Circuit Changes in Neonatal Intensive Care Unit: Prospective, Randomized Study

The purpose of this study is to determine incidence of ventilator-associated pneumonia compared between weekly and no routine ventilator circuit changes in neonatal intensive care unit

Study Overview

• Status: Terminated
• Conditions: Pneumonia, Ventilator-Associated
• Intervention / Treatment: Device: Infant Ventilator Circuit Dual Heated with Autofeed Chamber

Detailed Description

Parents were received informed consent. Enrolled neonates was randomly assigned to 2 groups as 7-day ventilator circuit change and no change group by computerization with allocated of concealment. The investigation team opened the next sequentially numbered study pack, which was stored in the neonatal unit. The assignment sequence was generated with balance within random block sizes of 4. Stratification according to birthweight was done before randomization to control for differences in patient populations. Patient characteristics were recorded as gestational age, sex, birthweight, underlying disease, date of intubation, date of extubation, duration of mechanical ventilator, reintubation, length of hospital stay, parenteral nutrition, medication (H2-blocker, PPI, narcotic drugs), transfusion and oral immune therapy. Laboratory data and radiographic data were recorded. Both groups received similarly care as the nurse was assigned to take care of patient in ratio 1-2 patients: 1 nurse, new disposable circuits were use in both groups and the VAP prevention protocol and the endotracheal suctioning protocol which followed by an American Academy of Respiratory Care (AARC) clinical practice guidelines were performed in both groups.

When the VAP was suspected the radiographic data were reviewed by two pediatric radiologists on the day of diagnosis, 3 days prior to the diagnosis and/or 2 and 7 days after diagnosis to confirm diagnosis of VAP if there is different in the results, the consensus must be made.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Songkhla
    • Hat-Yai, Songkhla, Thailand, 90110
      • Songklanagarind Hospital, Prince of Songkla University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 1 year (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• All neonates who admitted at neonatal intensive care unit (NICU) and required ventilator support with both intubated at time of neonatal resuscitation and within the NICU as indicated

Exclusion Criteria:

• Patient was extubated or died within 2 calendar days of endotracheal intubation
• Pneumonia was diagnosed before intubation
• Outborn who was intubated before referred
• Parents declined to participate
• Incompatibility of disposable circuits and ventilator
• Chromosome abnormality or moribund

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Weekly ventilator circuit change; Ventilator circuit change every 7 days until extubation	Device: Infant Ventilator Circuit Dual Heated with Autofeed Chamber; Other Names: Evaqua2, RT265
Active Comparator: No routine ventilator circuit change; No routine ventilator circuit change until soiling or malfunction or extubation	Device: Infant Ventilator Circuit Dual Heated with Autofeed Chamber; Other Names: Evaqua2, RT265

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of ventilator-associated pneumonia (percentage of ventilator-associated pneumonia (events)/mechanically ventilated infant)	percentage of ventilator-associated pneumonia (events)/mechanically ventilated infant	within the first 30 days (plus or minus 7 days) after extubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of ventilator-associated pneumonia (ventilator-associated pneumonia (events)/1,000 ventilator days)	ventilator-associated pneumonia (events)/1,000 ventilator days	within the first 30 days (plus or minus 7 days) after extubation
Mortality rate	pneumonia-specific mortality within 7 days and at discharge	within the first 30 days (plus or minus 7 days) after discharge

Collaborators and Investigators

• Sponsor: Prince of Songkla University
• Investigators: Principal Investigator: Anucha Thatrimontrichai, MD, Prince of Songkla University

Publications and helpful links

General Publications

• Apisarnthanarak A, Holzmann-Pazgal G, Hamvas A, Olsen MA, Fraser VJ. Ventilator-associated pneumonia in extremely preterm neonates in a neonatal intensive care unit: characteristics, risk factors, and outcomes. Pediatrics. 2003 Dec;112(6 Pt 1):1283-9. doi: 10.1542/peds.112.6.1283.
• Cernada M, Aguar M, Brugada M, Gutierrez A, Lopez JL, Castell M, Vento M. Ventilator-associated pneumonia in newborn infants diagnosed with an invasive bronchoalveolar lavage technique: a prospective observational study. Pediatr Crit Care Med. 2013 Jan;14(1):55-61. doi: 10.1097/PCC.0b013e318253ca31.
• Afjeh SA, Sabzehei MK, Karimi A, Shiva F, Shamshiri AR. Surveillance of ventilator-associated pneumonia in a neonatal intensive care unit: characteristics, risk factors, and outcome. Arch Iran Med. 2012 Sep;15(9):567-71.
• Kawanishi F, Yoshinaga M, Morita M, Shibata Y, Yamada T, Ooi Y, Ukimura A. Risk factors for ventilator-associated pneumonia in neonatal intensive care unit patients. J Infect Chemother. 2014 Oct;20(10):627-30. doi: 10.1016/j.jiac.2014.06.006. Epub 2014 Jul 4.
• Han J, Liu Y. Effect of ventilator circuit changes on ventilator-associated pneumonia: a systematic review and meta-analysis. Respir Care. 2010 Apr;55(4):467-74.
• Makhoul IR, Kassis I, Berant M, Hashman N, Revach M, Sujov P. Frequency of change of ventilator circuit in premature infants: Impact on ventilator-associated pneumonia. Pediatr Crit Care Med. 2001 Apr;2(2):127-132. doi: 10.1097/00130478-200104000-00006.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: December 22, 2014
• First Submitted That Met QC Criteria: December 24, 2014
• First Posted (Estimated): December 25, 2014

Study Record Updates

• Last Update Posted (Estimated): June 13, 2023
• Last Update Submitted That Met QC Criteria: June 11, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Infant, Newborn; Neonatal intensive care unit; Ventilator circuit
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Pneumonia, Ventilator-Associated
• Other Study ID Numbers: PSU 2014