CDH - Optimisation of Neonatal Ventilation

NCT ID: NCT02849054

Last Updated: 2018-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2021-12-31

Brief Summary

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

Detailed Description

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Conditions

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Congenital Diaphragmatic Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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4, 5, 6ml/kg targetted tidal volume

Randomised to receive TTV at 4ml/kg, 5ml/kg, 6ml/kg. Measurement of PTPdi

Group Type EXPERIMENTAL

Measurement of PTPdi

Intervention Type DEVICE

Insertion of pressure transducer catheter to measure gastic and oesophadgeal pressures for calculation of PTPdi

TTV at 4ml/kg

Intervention Type DEVICE

Provision of targetted tidal volume of 4ml/kg

TTV at 5ml/kg

Intervention Type DEVICE

Provision of targetted tidal volume of 5ml/kg

TTV at 6ml/kg

Intervention Type DEVICE

Provision of targetted tidal volume of 6ml/kg

4, 6, 5ml/kg targetted tidal volume

Randomised to receive TTV at 4ml/kg, 6ml/kg, 5ml/kg. Measurement of PTPdi

Group Type EXPERIMENTAL

Measurement of PTPdi

Intervention Type DEVICE

Insertion of pressure transducer catheter to measure gastic and oesophadgeal pressures for calculation of PTPdi

TTV at 4ml/kg

Intervention Type DEVICE

Provision of targetted tidal volume of 4ml/kg

TTV at 5ml/kg

Intervention Type DEVICE

Provision of targetted tidal volume of 5ml/kg

TTV at 6ml/kg

Intervention Type DEVICE

Provision of targetted tidal volume of 6ml/kg

5, 4, 6ml/kg targetted tidal volume

Randomised to receive TTV at 5ml/kg, 4ml/kg, 6ml/kg. Measurement of PTPdi

Group Type EXPERIMENTAL

Measurement of PTPdi

Intervention Type DEVICE

Insertion of pressure transducer catheter to measure gastic and oesophadgeal pressures for calculation of PTPdi

TTV at 4ml/kg

Intervention Type DEVICE

Provision of targetted tidal volume of 4ml/kg

TTV at 5ml/kg

Intervention Type DEVICE

Provision of targetted tidal volume of 5ml/kg

TTV at 6ml/kg

Intervention Type DEVICE

Provision of targetted tidal volume of 6ml/kg

5, 6, 4ml/kg targetted tidal volume

Randomised to receive TTV at 5ml/kg, 6ml/kg,4ml/kg. Measurement of PTPdi

Group Type EXPERIMENTAL

Measurement of PTPdi

Intervention Type DEVICE

Insertion of pressure transducer catheter to measure gastic and oesophadgeal pressures for calculation of PTPdi

TTV at 4ml/kg

Intervention Type DEVICE

Provision of targetted tidal volume of 4ml/kg

TTV at 5ml/kg

Intervention Type DEVICE

Provision of targetted tidal volume of 5ml/kg

TTV at 6ml/kg

Intervention Type DEVICE

Provision of targetted tidal volume of 6ml/kg

6, 5, 4ml/kg targetted tidal volume

Randomised to receive TTV at 6ml/kg, 5ml/kg, 4ml/kg. Measurement of PTPdi

Group Type EXPERIMENTAL

Measurement of PTPdi

Intervention Type DEVICE

Insertion of pressure transducer catheter to measure gastic and oesophadgeal pressures for calculation of PTPdi

TTV at 4ml/kg

Intervention Type DEVICE

Provision of targetted tidal volume of 4ml/kg

TTV at 5ml/kg

Intervention Type DEVICE

Provision of targetted tidal volume of 5ml/kg

TTV at 6ml/kg

Intervention Type DEVICE

Provision of targetted tidal volume of 6ml/kg

6, 4, 5ml/kg targetted tidal volume

Randomised to receive TTV at 6ml/kg, 4ml/kg, 5ml/kg. Measurement of PTPdi

Group Type EXPERIMENTAL

Measurement of PTPdi

Intervention Type DEVICE

Insertion of pressure transducer catheter to measure gastic and oesophadgeal pressures for calculation of PTPdi

TTV at 4ml/kg

Intervention Type DEVICE

Provision of targetted tidal volume of 4ml/kg

TTV at 5ml/kg

Intervention Type DEVICE

Provision of targetted tidal volume of 5ml/kg

TTV at 6ml/kg

Intervention Type DEVICE

Provision of targetted tidal volume of 6ml/kg

Interventions

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Measurement of PTPdi

Insertion of pressure transducer catheter to measure gastic and oesophadgeal pressures for calculation of PTPdi

Intervention Type DEVICE

TTV at 4ml/kg

Provision of targetted tidal volume of 4ml/kg

Intervention Type DEVICE

TTV at 5ml/kg

Provision of targetted tidal volume of 5ml/kg

Intervention Type DEVICE

TTV at 6ml/kg

Provision of targetted tidal volume of 6ml/kg

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* neuromuscular blockade contraindications to NG/OG tube insertion
Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King's College Hospital NHS Trust

OTHER

Sponsor Role collaborator

King's College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne Greenough, MD, MBBS

Role: PRINCIPAL_INVESTIGATOR

King's College London

Locations

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King's College Hospital

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Katie Hunt, MA, MBBS

Role: CONTACT

00442032999000 ext. 38492

Facility Contacts

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Katie Hunt, MA, MBBS

Role: primary

00442032999000 ext. 38492

Other Identifiers

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KCH16-080

Identifier Type: -

Identifier Source: org_study_id

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