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
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
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
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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