CDH - Optimisation of Neonatal Ventilation

Study Overview
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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.

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

Conditions
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Congenital Diaphragmatic Hernia

Intervention / Treatment
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* Device: Measurement of PTPdi
* Device: TTV at 4ml/kg
* Device: TTV at 5ml/kg
* Device: TTV at 6ml/kg


Participation Criteria
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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

Ages Eligible for Study
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Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | PTPdi will be measured at each level of tidal volume. The outcome measure is the change in PTPdi. | 3 hours |