Trial of Weaning by Synchronized Ventilation

This study has been completed.
Sponsor:
Information provided by:
King's College London
ClinicalTrials.gov Identifier:
NCT01376544
First received: May 26, 2011
Last updated: June 17, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention
Neonatal Respiratory Failure
Device: Treatment protocol designed to evaluate (SLE 5000 ventilator)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomised Trial Comparing Assist Control Ventilation to Pressure Support Ventilation During Weaning

Further study details as provided by King's College London:

Primary Outcome Measures:
  • To determine which mode of ventilation was associated with a shorter duration of weaning. [ Time Frame: Up to 28 days after birth ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Work of breathing thoraco-abdominal asynchrony respiratory muscle strength [ Time Frame: Baseline, 24 hours and prior to extubation ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: August 2008
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Assist control ventilation
Assist control ventilation
Device: Treatment protocol designed to evaluate (SLE 5000 ventilator)
Assist control ventilation and pressure support ventilation
Other Name: SLE 5000 ventilator
Active Comparator: Pressure support ventilation Device: Treatment protocol designed to evaluate (SLE 5000 ventilator)
Assist control ventilation and pressure support ventilation
Other Name: SLE 5000 ventilator

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.

  Eligibility

Ages Eligible for Study:   up to 14 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ventilated neonates less than 14 days of age

Exclusion Criteria:

  • Congenital heart disease, hypoxic ischaemic encephalopathy
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01376544

Locations
United Kingdom
Neonatal Intensive Care Unit
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
King's College London
Investigators
Principal Investigator: Anne Greenough, MD King's College London
  More Information

No publications provided

Responsible Party: Professor Anne Greenough, King's College London
ClinicalTrials.gov Identifier: NCT01376544     History of Changes
Other Study ID Numbers: 07/H0808/147
Study First Received: May 26, 2011
Last Updated: June 17, 2011
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by King's College London:
Neonate
Weaning
Assist control ventilation
Pressure support ventilation

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 29, 2014