Trial of Weaning by Synchronized Ventilation

Neonatal Respiratory Failure Clinical Trial

Official title:

Randomised Trial Comparing Assist Control Ventilation to Pressure Support Ventilation During Weaning

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01376544
• Other study ID #: 07/H0808/147
• Status: Completed
• Phase: N/A
• First received: May 26, 2011
• Last updated: June 17, 2011
• Start date: August 2008
• Est. completion date: August 2010

Study information

• Verified date: June 2011
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 14 Days

Eligibility

Inclusion Criteria:

• Ventilated neonates less than 14 days of age

Exclusion Criteria:

• Congenital heart disease, hypoxic ischaemic encephalopathy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neonatal Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• Treatment protocol designed to evaluate (SLE 5000 ventilator)
Assist control ventilation and pressure support ventilation

Locations

Country	Name	City	State
United Kingdom	Neonatal Intensive Care Unit	London

Sponsors (1)

Lead Sponsor	Collaborator
King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine which mode of ventilation was associated with a shorter duration of weaning.		Up to 28 days after birth	No
Secondary	Change in Work of breathing thoraco-abdominal asynchrony respiratory muscle strength		Baseline, 24 hours and prior to extubation	No