Trial of Weaning by Synchronized Ventilation
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 ]
- 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 |
Inclusion Criteria:
- Ventilated neonates less than 14 days of age
Exclusion Criteria:
- Congenital heart disease, hypoxic ischaemic encephalopathy
Contacts and Locations
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 May 22, 2013