Weekly Versus no Routine Ventilator Circuit Changes in NICU

NCT02326207 | Terminated DMC

• 1 other identifier: PSU 2014
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pneumonia, Ventilator-Associated

Keywords

Infant, Newborn; Neonatal intensive care unit; Ventilator circuit

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• incidence of ventilator-associated pneumonia (ventilator-associated pneumonia (events)/1,000 ventilator days)

  within the first 30 days (plus or minus 7 days) after extubation

• Mortality rate

  within the first 30 days (plus or minus 7 days) after discharge

Study Arms (2)

Weekly ventilator circuit change

EXPERIMENTAL

Ventilator circuit change every 7 days until extubation

Device: Infant Ventilator Circuit Dual Heated with Autofeed Chamber

No routine ventilator circuit change

ACTIVE COMPARATOR

No routine ventilator circuit change until soiling or malfunction or extubation

Device: Infant Ventilator Circuit Dual Heated with Autofeed Chamber

Interventions

Infant Ventilator Circuit Dual Heated with Autofeed Chamber DEVICE

Also known as: Evaqua2, RT265

No routine ventilator circuit change; Weekly ventilator circuit change

Eligibility Criteria

• Age: 1 Day - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prince of Songkla University: lead

Study Sites (1)

Songklanagarind Hospital, Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

Related Publications (6)

• 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.

  PMID: 22791095 BACKGROUND

• 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.

  PMID: 14654598 BACKGROUND

• 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.

  PMID: 22924377 BACKGROUND

• 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.

  PMID: 25000829 BACKGROUND

• 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.

  PMID: 20406515 BACKGROUND

• 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.

  PMID: 12797871 BACKGROUND

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anucha Thatrimontrichai, MD

  Prince of Songkla University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mr

Study Record Dates

• First Submitted: December 22, 2014
• First Posted: December 25, 2014
• Study Start: April 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: June 13, 2023

Record last verified: 2023-06

Locations

TH (1)