WithdrawnNot Applicable

Positive Pressure Ventilation and Sternal Closure in HLHS

Stopped: Needed equipment failed before the study was started.

Canada0Started 2015-02

Plain-language summary

This study will examine the cardiopulmonary interactions that occur with increasing ventilator settings (PEEP and PIP) in neonates after stage I palliation for hypoplastic left heart syndrome before and after sternal closure. Outcome measures include oxygen delivery and cardiac output.

Who can participate

Age range1 Month

SexALL

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Exclusion criteria

✕. History of pneumothorax, acute respiratory distress syndrome, or other contraindication to the proposed ventilator manipulations as determined by the responsible CCCU staff physician.
✕. Endotracheal tube leak \> 15%.
✕. Lack of informed consent from parents.
✕. Weight less than 2.6kg

What they're measuring

Oxygen Delivery calculated from direct measurements of oxygen consumption via respiratory mass spectrometry

Timeframe: Measurements made 15 minutes after each ventilator change. Total duration of observation is 2.5 hours.

Trial details

NCT IDNCT02455713

SponsorThe Hospital for Sick Children

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2016-12

View on ClinicalTrials.gov More Hypoplastic Left Heart Syndrome trials