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Weekly Versus no Routine Ventilator Circuit Changes in NICU

Primary Purpose

Pneumonia, Ventilator-Associated

Status
Terminated
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Infant Ventilator Circuit Dual Heated with Autofeed Chamber
Sponsored by
Prince of Songkla University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Pneumonia, Ventilator-Associated focused on measuring Infant, Newborn, Neonatal intensive care unit, Ventilator circuit

Eligibility Criteria

1 Day - 1 Year (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Songklanagarind Hospital, Prince of Songkla University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Weekly ventilator circuit change

No routine ventilator circuit change

Arm Description

Ventilator circuit change every 7 days until extubation

No routine ventilator circuit change until soiling or malfunction or extubation

Outcomes

Primary Outcome Measures

incidence of ventilator-associated pneumonia (percentage of ventilator-associated pneumonia (events)/mechanically ventilated infant)
percentage of ventilator-associated pneumonia (events)/mechanically ventilated infant

Secondary Outcome Measures

incidence of ventilator-associated pneumonia (ventilator-associated pneumonia (events)/1,000 ventilator days)
ventilator-associated pneumonia (events)/1,000 ventilator days
Mortality rate
pneumonia-specific mortality within 7 days and at discharge

Full Information

First Posted
December 22, 2014
Last Updated
June 11, 2023
Sponsor
Prince of Songkla University
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1. Study Identification

Unique Protocol Identification Number
NCT02326207
Brief Title
Weekly Versus no Routine Ventilator Circuit Changes in NICU
Official Title
Weekly Versus no Routine Ventilator Circuit Changes in Neonatal Intensive Care Unit: Prospective, Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Terminated
Why Stopped
very low enrolled participants
Study Start Date
April 2015 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prince of Songkla University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Ventilator-Associated
Keywords
Infant, Newborn, Neonatal intensive care unit, Ventilator circuit

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Weekly ventilator circuit change
Arm Type
Experimental
Arm Description
Ventilator circuit change every 7 days until extubation
Arm Title
No routine ventilator circuit change
Arm Type
Active Comparator
Arm Description
No routine ventilator circuit change until soiling or malfunction or extubation
Intervention Type
Device
Intervention Name(s)
Infant Ventilator Circuit Dual Heated with Autofeed Chamber
Other Intervention Name(s)
Evaqua2, RT265
Primary Outcome Measure Information:
Title
incidence of ventilator-associated pneumonia (percentage of ventilator-associated pneumonia (events)/mechanically ventilated infant)
Description
percentage of ventilator-associated pneumonia (events)/mechanically ventilated infant
Time Frame
within the first 30 days (plus or minus 7 days) after extubation
Secondary Outcome Measure Information:
Title
incidence of ventilator-associated pneumonia (ventilator-associated pneumonia (events)/1,000 ventilator days)
Description
ventilator-associated pneumonia (events)/1,000 ventilator days
Time Frame
within the first 30 days (plus or minus 7 days) after extubation
Title
Mortality rate
Description
pneumonia-specific mortality within 7 days and at discharge
Time Frame
within the first 30 days (plus or minus 7 days) after discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anucha Thatrimontrichai, MD
Organizational Affiliation
Prince of Songkla University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Songklanagarind Hospital, Prince of Songkla University
City
Hat-Yai
State/Province
Songkhla
ZIP/Postal Code
90110
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
22791095
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.
Results Reference
background
PubMed Identifier
14654598
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.
Results Reference
background
PubMed Identifier
22924377
Citation
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.
Results Reference
background
PubMed Identifier
25000829
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.
Results Reference
background
PubMed Identifier
20406515
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.
Results Reference
background
PubMed Identifier
12797871
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.
Results Reference
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Weekly Versus no Routine Ventilator Circuit Changes in NICU

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