CompletedNot Applicable

Impact of Chest Wall Mechanics on Lung and Cardiovascular Function During Delayed Sternal Closure

Canada10 participantsStarted 2022-08-26

Plain-language summary

This study aims to describe chest wall mechanics during delayed sternal closure (DSC) in neonates following cardiopulmonary bypass or palliation of congenital heart diseases.

Who can participate

Age range28 Days

SexALL

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Inclusion criteria

✓. Informed consent provided by parent or primary guardian.
✓. Aged \<28 days of life at the time of cardiac surgery.
✓. Undergone surgery using CPB for congenital heart disease.
✓. Undergoing DSC in CCCU.

Exclusion criteria

✕. Gestational age \< 37 weeks or weight \< 2 kg at the time of surgery.
✕. Endotracheal tube leak \>20%.
✕. Need of extracorporeal support (ECMO), inhaled nitric oxide.
✕. Pre-existing pulmonary disease (For example: Congenital diaphragmatic hernia).
✕. Pre-existing or new arrhythmia that can impact hemodynamic assessment.
✕. Severe coagulopathy or any other contraindication for the insertion of a nasogastric catheter (e.g., history of tracheo-esophageal fistula).

What they're measuring

Percentage of patients with successful insertion and measurement of esophageal pressures

Timeframe: Immediately prior to chest closure and repeated measurements after chest closure

Trial details

NCT IDNCT05257525

SponsorThe Hospital for Sick Children

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-26

View on ClinicalTrials.gov More Palliation of Congenital Heart Diseases trials