Weekly Versus no Routine Ventilator Circuit Changes in NICU

Prince of Songkla University

Status: Terminated

Conditions: Pneumonia, Ventilator-Associated

Treatments: Device: Infant Ventilator Circuit Dual Heated with Autofeed Chamber

Study type: Interventional

Funder types: Other

Identifiers

NCT02326207

PSU 2014

Details and patient eligibility

About

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

Full 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.

Enrollment: 19 patients

Sex: All

Ages: 1 day to 1 year old

Volunteers: No 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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19 participants in 2 patient groups

Weekly ventilator circuit change

Experimental group

Description:

Ventilator circuit change every 7 days until extubation

Treatment:

Device: Infant Ventilator Circuit Dual Heated with Autofeed Chamber

No routine ventilator circuit change

Active Comparator group

Description:

No routine ventilator circuit change until soiling or malfunction or extubation

Treatment:

Device: Infant Ventilator Circuit Dual Heated with Autofeed Chamber