CDH - Optimisation of Neonatal Ventilation

Not Applicable

• Conditions: Congenital Diaphragmatic Hernia
• Interventions: Device: Measurement of PTPdi; Device: TTV at 4ml/kg; Device: TTV at 5ml/kg; Device: TTV at 6ml/kg

• Registration Number: NCT02849054
• Lead Sponsor: King's College London

Brief Summary

To determine the appropriate volume (size) of ventilator breath during volume-targetted ventilation for infants born with congenital diaphragmatic hernia.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-07-18
• Study First Submitted QC: 2016-07-26
• Study First Posted: 2016-07-29
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-28
• Last Update Posted: 2018-08-29
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Congenital diaphragmatic hernia - post-operative Mechanically ventilated Born at >34/40

Exclusion Criteria

• neuromuscular blockade contraindications to NG/OG tube insertion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
4, 6, 5ml/kg targetted tidal volume	TTV at 6ml/kg	Randomised to receive TTV at 4ml/kg, 6ml/kg, 5ml/kg. Measurement of PTPdi
4, 5, 6ml/kg targetted tidal volume	TTV at 5ml/kg	Randomised to receive TTV at 4ml/kg, 5ml/kg, 6ml/kg. Measurement of PTPdi
4, 6, 5ml/kg targetted tidal volume	Measurement of PTPdi	Randomised to receive TTV at 4ml/kg, 6ml/kg, 5ml/kg. Measurement of PTPdi
5, 6, 4ml/kg targetted tidal volume	Measurement of PTPdi	Randomised to receive TTV at 5ml/kg, 6ml/kg,4ml/kg. Measurement of PTPdi
4, 5, 6ml/kg targetted tidal volume	TTV at 6ml/kg	Randomised to receive TTV at 4ml/kg, 5ml/kg, 6ml/kg. Measurement of PTPdi
4, 6, 5ml/kg targetted tidal volume	TTV at 4ml/kg	Randomised to receive TTV at 4ml/kg, 6ml/kg, 5ml/kg. Measurement of PTPdi
4, 5, 6ml/kg targetted tidal volume	Measurement of PTPdi	Randomised to receive TTV at 4ml/kg, 5ml/kg, 6ml/kg. Measurement of PTPdi
4, 5, 6ml/kg targetted tidal volume	TTV at 4ml/kg	Randomised to receive TTV at 4ml/kg, 5ml/kg, 6ml/kg. Measurement of PTPdi
5, 4, 6ml/kg targetted tidal volume	TTV at 6ml/kg	Randomised to receive TTV at 5ml/kg, 4ml/kg, 6ml/kg. Measurement of PTPdi
6, 4, 5ml/kg targetted tidal volume	TTV at 6ml/kg	Randomised to receive TTV at 6ml/kg, 4ml/kg, 5ml/kg. Measurement of PTPdi
4, 6, 5ml/kg targetted tidal volume	TTV at 5ml/kg	Randomised to receive TTV at 4ml/kg, 6ml/kg, 5ml/kg. Measurement of PTPdi
5, 4, 6ml/kg targetted tidal volume	TTV at 4ml/kg	Randomised to receive TTV at 5ml/kg, 4ml/kg, 6ml/kg. Measurement of PTPdi
5, 6, 4ml/kg targetted tidal volume	TTV at 6ml/kg	Randomised to receive TTV at 5ml/kg, 6ml/kg,4ml/kg. Measurement of PTPdi
5, 4, 6ml/kg targetted tidal volume	Measurement of PTPdi	Randomised to receive TTV at 5ml/kg, 4ml/kg, 6ml/kg. Measurement of PTPdi
5, 6, 4ml/kg targetted tidal volume	TTV at 4ml/kg	Randomised to receive TTV at 5ml/kg, 6ml/kg,4ml/kg. Measurement of PTPdi
5, 6, 4ml/kg targetted tidal volume	TTV at 5ml/kg	Randomised to receive TTV at 5ml/kg, 6ml/kg,4ml/kg. Measurement of PTPdi
6, 5, 4ml/kg targetted tidal volume	TTV at 4ml/kg	Randomised to receive TTV at 6ml/kg, 5ml/kg, 4ml/kg. Measurement of PTPdi
6, 5, 4ml/kg targetted tidal volume	TTV at 6ml/kg	Randomised to receive TTV at 6ml/kg, 5ml/kg, 4ml/kg. Measurement of PTPdi
6, 4, 5ml/kg targetted tidal volume	Measurement of PTPdi	Randomised to receive TTV at 6ml/kg, 4ml/kg, 5ml/kg. Measurement of PTPdi
6, 4, 5ml/kg targetted tidal volume	TTV at 5ml/kg	Randomised to receive TTV at 6ml/kg, 4ml/kg, 5ml/kg. Measurement of PTPdi
5, 4, 6ml/kg targetted tidal volume	TTV at 5ml/kg	Randomised to receive TTV at 5ml/kg, 4ml/kg, 6ml/kg. Measurement of PTPdi
6, 5, 4ml/kg targetted tidal volume	Measurement of PTPdi	Randomised to receive TTV at 6ml/kg, 5ml/kg, 4ml/kg. Measurement of PTPdi
6, 5, 4ml/kg targetted tidal volume	TTV at 5ml/kg	Randomised to receive TTV at 6ml/kg, 5ml/kg, 4ml/kg. Measurement of PTPdi
6, 4, 5ml/kg targetted tidal volume	TTV at 4ml/kg	Randomised to receive TTV at 6ml/kg, 4ml/kg, 5ml/kg. Measurement of PTPdi

Primary Outcome Measures

Name	Time	Method
Change in Pressure Time Product of the diaphragm (PTPdi) at different levels of targetted tidal volume	3 hours	PTPdi will be measured at each level of tidal volume. The outcome measure is the change in PTPdi.

Trial Locations

Locations (1)

King's College Hospital; 🇬🇧 London, United Kingdom