CDH - Optimisation of Neonatal Ventilation (CDH-ONV)

August 28, 2018 updated by: King's College London

Optimisation of Neonatal Ventilation: Congenital Diaphragmatic Hernia - Determining the Appropriate Level of Volume Guarantee

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 6 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • neuromuscular blockade contraindications to NG/OG tube insertion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 4, 5, 6ml/kg targetted tidal volume
Randomised to receive TTV at 4ml/kg, 5ml/kg, 6ml/kg. Measurement of PTPdi
Device: Measurement of PTPdi
Insertion of pressure transducer catheter to measure gastic and oesophadgeal pressures for calculation of PTPdi
Device: TTV at 4ml/kg
Provision of targetted tidal volume of 4ml/kg
Device: TTV at 5ml/kg
Provision of targetted tidal volume of 5ml/kg
Device: TTV at 6ml/kg
Provision of targetted tidal volume of 6ml/kg
Experimental: 4, 6, 5ml/kg targetted tidal volume
Randomised to receive TTV at 4ml/kg, 6ml/kg, 5ml/kg. Measurement of PTPdi
Device: Measurement of PTPdi
Insertion of pressure transducer catheter to measure gastic and oesophadgeal pressures for calculation of PTPdi
Device: TTV at 4ml/kg
Provision of targetted tidal volume of 4ml/kg
Device: TTV at 5ml/kg
Provision of targetted tidal volume of 5ml/kg
Device: TTV at 6ml/kg
Provision of targetted tidal volume of 6ml/kg
Experimental: 5, 4, 6ml/kg targetted tidal volume
Randomised to receive TTV at 5ml/kg, 4ml/kg, 6ml/kg. Measurement of PTPdi
Device: Measurement of PTPdi
Insertion of pressure transducer catheter to measure gastic and oesophadgeal pressures for calculation of PTPdi
Device: TTV at 4ml/kg
Provision of targetted tidal volume of 4ml/kg
Device: TTV at 5ml/kg
Provision of targetted tidal volume of 5ml/kg
Device: TTV at 6ml/kg
Provision of targetted tidal volume of 6ml/kg
Experimental: 5, 6, 4ml/kg targetted tidal volume
Randomised to receive TTV at 5ml/kg, 6ml/kg,4ml/kg. Measurement of PTPdi
Device: Measurement of PTPdi
Insertion of pressure transducer catheter to measure gastic and oesophadgeal pressures for calculation of PTPdi
Device: TTV at 4ml/kg
Provision of targetted tidal volume of 4ml/kg
Device: TTV at 5ml/kg
Provision of targetted tidal volume of 5ml/kg
Device: TTV at 6ml/kg
Provision of targetted tidal volume of 6ml/kg
Experimental: 6, 5, 4ml/kg targetted tidal volume
Randomised to receive TTV at 6ml/kg, 5ml/kg, 4ml/kg. Measurement of PTPdi
Device: Measurement of PTPdi
Insertion of pressure transducer catheter to measure gastic and oesophadgeal pressures for calculation of PTPdi
Device: TTV at 4ml/kg
Provision of targetted tidal volume of 4ml/kg
Device: TTV at 5ml/kg
Provision of targetted tidal volume of 5ml/kg
Device: TTV at 6ml/kg
Provision of targetted tidal volume of 6ml/kg
Experimental: 6, 4, 5ml/kg targetted tidal volume
Randomised to receive TTV at 6ml/kg, 4ml/kg, 5ml/kg. Measurement of PTPdi
Device: Measurement of PTPdi
Insertion of pressure transducer catheter to measure gastic and oesophadgeal pressures for calculation of PTPdi
Device: TTV at 4ml/kg
Provision of targetted tidal volume of 4ml/kg
Device: TTV at 5ml/kg
Provision of targetted tidal volume of 5ml/kg
Device: TTV at 6ml/kg
Provision of targetted tidal volume of 6ml/kg

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College London

Collaborators

King's College Hospital NHS Trust

Investigators

  • Principal Investigator: Anne Greenough, MD, MBBS, King's College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

July 18, 2016

First Submitted That Met QC Criteria

July 26, 2016

First Posted (Estimate)

July 29, 2016

Study Record Updates

Last Update Posted (Actual)

August 29, 2018

Last Update Submitted That Met QC Criteria

August 28, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KCH16-080

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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