Randomised Controlled Trial Comparing Volume-targeted to Pressure-limited Ventilation in Infants Born at or Near Term
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Respiratory Insufficiency
- Sponsor
- King's College London
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Duration of mechanical ventilation
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
A randomised controlled trial comparing volume-targeted ventilation to pressure-limited ventilation in infants born at or near term.
Detailed Description
Aims: There is increasing evidence that volume-targeted ventilation (VTV) holds benefits for preterm infants in comparison to pressure-limited ventilation. It is not known whether the same is true in the case of infants born at term. This study aims to compare pressure-limited to VTV in term-born infants. Hypothesis: Volume-targeted will be associated with significantly earlier extubation compared to pressure-limited ventilation Primary outcome: Time to extubation. Methods: Ventilated infants 34 weeks or more gestational age at birth were recruited and randomly allocated to receive either pressure-limited or VTV. Adjustments to ventilator settings were made according to the trial protocol. Infants were deemed to have met failure criteria if they required HFOV or peak pressures of more than 30 cm of water. Analysis will be by intention-to-treat.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Mechanically ventilated
- •Born at gestation 34 weeks and above
Exclusion Criteria
- •Congenital diaphragmatic hernia
- •Congenital heart disease
Outcomes
Primary Outcomes
Duration of mechanical ventilation
Time Frame: For each patient, the exact number of hours from the date and time of randomisation to the date and time of successful removal of the endotracheal tube, assessed up to 4 weeks.
Data will be collected from the intensive care observation chart to determine the time at which the infant was successfully taken off of mechanical ventilation, assessed up to 4 weeks.