Trial of Weaning by Synchronized Ventilation

Study Overview
=================
Brief Summary
-----------------
During assist control ventilation and pressure support ventilation (PSV), the start of ventilator inflation is determined by the start of the infant's inspiratory effort. During PSV, termination of inflation is determined by the level of the infant's inspiratory flow. In a randomized trial, no significant differences were found between assist control and pressure support ventilation with regard to the duration of weaning, time to successful extubation, work of breathing, rate of asynchrony and level of respiratory muscle strength.

Detailed Description
-----------------
Objectives: To test the hypothesis that the duration of weaning would be shorter using assist control ventilation (ACV) rather than pressure support ventilation (PSV). To determine if any differences in the duration of weaning reflected differences in the work of breathing, the rate of asynchrony or the level of respiratory muscle strength. Patients and methods: Thirty-six infants, median gestational age 29 (range 24 to 39) weeks, were randomized to weaning by either ACV or PSV. The duration of weaning was recorded. At baseline (study entry), 24 hours after entering the study and immediately prior to extubation, the work of breathing was assessed by measuring the transdiaphragmatic pressure time product (PTPdi), thoracoabdominal asynchrony (TAA) was assessed using respiratory inductance plethysmography and respiratory muscle strength measured by recording the maximal inspiratory pressure produced during an airway occlusion during crying (Pimax). Immediately prior to extubation, the level of active expiration was also assessed.

Official Title
-----------------
Randomised Trial Comparing Assist Control Ventilation to Pressure Support Ventilation During Weaning

Conditions
-----------------
Neonatal Respiratory Failure

Intervention / Treatment
-----------------
* Device: Treatment protocol designed to evaluate (SLE 5000 ventilator)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ventilated neonates less than 14 days of age Exclusion Criteria: Congenital heart disease, hypoxic ischaemic encephalopathy

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 14 Days

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Assist control ventilation<br>Assist control ventilation | Device: Treatment protocol designed to evaluate (SLE 5000 ventilator)<br>* Assist control ventilation and pressure support ventilation<br>* Other names: SLE 5000 ventilator;|
| Active Comparator: Pressure support ventilation<br> | Device: Treatment protocol designed to evaluate (SLE 5000 ventilator)<br>* Assist control ventilation and pressure support ventilation<br>* Other names: SLE 5000 ventilator;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine which mode of ventilation was associated with a shorter duration of weaning. |  | Up to 28 days after birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Work of breathing thoraco-abdominal asynchrony respiratory muscle strength |  | Baseline, 24 hours and prior to extubation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neonate, Weaning, Assist control ventilation, Pressure support ventilation