Trial of Weaning by Synchronized Ventilation

NCT ID: NCT01376544

Last Updated: 2011-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2010-08-31

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.

Conditions

Neonatal Respiratory Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Assist control ventilation

Assist control ventilation

Group Type: ACTIVE_COMPARATOR

Treatment protocol designed to evaluate (SLE 5000 ventilator)

Intervention Type: DEVICE

Assist control ventilation and pressure support ventilation

Pressure support ventilation

Group Type: ACTIVE_COMPARATOR

Treatment protocol designed to evaluate (SLE 5000 ventilator)

Intervention Type: DEVICE

Assist control ventilation and pressure support ventilation

Interventions

Treatment protocol designed to evaluate (SLE 5000 ventilator)

Assist control ventilation and pressure support ventilation

Intervention Type: DEVICE

Other Intervention Names

SLE 5000 ventilator

Eligibility Criteria

Inclusion Criteria

• Ventilated neonates less than 14 days of age

Exclusion Criteria

• Congenital heart disease, hypoxic ischaemic encephalopathy

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 14 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King's College London

OTHER

Sponsor Role: lead

Responsible Party

King's College London

Principal Investigators

Anne Greenough, MD

Role: PRINCIPAL_INVESTIGATOR

King's College London

Locations

Neonatal Intensive Care Unit

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

07/H0808/147

Identifier Type: -

Identifier Source: org_study_id