Trials / Terminated
TerminatedNCT02326207
Weekly Versus no Routine Ventilator Circuit Changes in NICU
Weekly Versus no Routine Ventilator Circuit Changes in Neonatal Intensive Care Unit: Prospective, Randomized Study
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 19 (actual)
- Sponsor
- Prince of Songkla University · Academic / Other
- Sex
- All
- Age
- 1 Day – 1 Year
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Infant Ventilator Circuit Dual Heated with Autofeed Chamber |
Timeline
- Start date
- 2015-04-01
- Primary completion
- 2017-03-01
- Completion
- 2017-03-01
- First posted
- 2014-12-25
- Last updated
- 2023-06-13
Locations
1 site across 1 country: Thailand
Source: ClinicalTrials.gov record NCT02326207. Inclusion in this directory is not an endorsement.