Skip to main content
OpenTrials
Completed

NCT Number: NCT01376544

Trial of Weaning by Synchronized Ventilation

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Neonatal Respiratory Failure

Age range

1 day–14 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neonatal Intensive Care Unit

London, SE5 9RS, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ventilated neonates less than 14 days of age

Exclusion criteria

  • Congenital heart disease, hypoxic ischaemic encephalopathy

Treatment and study plan

Treatment protocol designed to evaluate (SLE 5000 ventilator)

Device

Assist control ventilation and pressure support ventilation

Other names: SLE 5000 ventilator

Primary outcomes

  1. To determine which mode of ventilation was associated with a shorter duration of weaning.

    Time frame: Up to 28 days after birth

Secondary outcomes

  1. Change in Work of breathing thoraco-abdominal asynchrony respiratory muscle strength

    Time frame: Baseline, 24 hours and prior to extubation

Sponsors and collaborators

Lead sponsor

King's College London

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jun 20, 2011
Registry last updated
Jun 20, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.