Weekly Versus no Routine Ventilator Circuit Changes in NICU

Pneumonia, Ventilator-Associated Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02326207
• Other study ID #: PSU 2014
• Status: Terminated
• Phase: N/A
• Start date: April 2015
• Est. completion date: March 2017

Study information

• Verified date: June 2023
• Source: Prince of Songkla University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 1 Year

Eligibility

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

Related Conditions & MeSH terms

• Pneumonia, Ventilator-Associated

Intervention

Device:
• Infant Ventilator Circuit Dual Heated with Autofeed Chamber

Locations

Country	Name	City	State
Thailand	Songklanagarind Hospital, Prince of Songkla University	Hat-Yai	Songkhla

Sponsors (1)

Lead Sponsor	Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Mortality rate	pneumonia-specific mortality within 7 days and at discharge	within the first 30 days (plus or minus 7 days) after discharge