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Trial of Weaning by Synchronized Ventilation

Primary Purpose

Neonatal Respiratory Failure

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Treatment protocol designed to evaluate (SLE 5000 ventilator)
Sponsored by
King's College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neonatal Respiratory Failure focused on measuring Neonate, Weaning, Assist control ventilation, Pressure support ventilation

Eligibility Criteria

1 Day - 14 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Ventilated neonates less than 14 days of age

Exclusion Criteria:

  • Congenital heart disease, hypoxic ischaemic encephalopathy

Sites / Locations

  • Neonatal Intensive Care Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Assist control ventilation

Pressure support ventilation

Arm Description

Assist control ventilation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 26, 2011
Last Updated
June 17, 2011
Sponsor
King's College London
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1. Study Identification

Unique Protocol Identification Number
NCT01376544
Brief Title
Trial of Weaning by Synchronized Ventilation
Official Title
Randomised Trial Comparing Assist Control Ventilation to Pressure Support Ventilation During Weaning
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
King's College London

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Respiratory Failure
Keywords
Neonate, Weaning, Assist control ventilation, Pressure support ventilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Assist control ventilation
Arm Type
Active Comparator
Arm Description
Assist control ventilation
Arm Title
Pressure support ventilation
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Treatment protocol designed to evaluate (SLE 5000 ventilator)
Other Intervention Name(s)
SLE 5000 ventilator
Intervention Description
Assist control ventilation and pressure support ventilation
Primary Outcome Measure Information:
Title
To determine which mode of ventilation was associated with a shorter duration of weaning.
Time Frame
Up to 28 days after birth
Secondary Outcome Measure Information:
Title
Change in Work of breathing thoraco-abdominal asynchrony respiratory muscle strength
Time Frame
Baseline, 24 hours and prior to extubation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
14 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ventilated neonates less than 14 days of age Exclusion Criteria: Congenital heart disease, hypoxic ischaemic encephalopathy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Greenough, MD
Organizational Affiliation
King's College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neonatal Intensive Care Unit
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Trial of Weaning by Synchronized Ventilation

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