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CompletedNo phase

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

Key facts

Who runs it
The Hospital for Sick Children
Where
Canada1 site in 1 countryChoose a country to see its sites
Trial code
Status
Completed
People taking part
10 people enrolled
Started
26 Aug 2022
Ended
8 Jan 2024
Type of study
Interventional, 2 groups
Treatments tested
  • Esophageal manometry catheter at various PEEP levels and tidal volumes
Record updated
16 July 2025

Who can take part

Age
Up to 28 days
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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)
  • 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

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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

The 2 groups in the trial

  • Univentricular physiologyOther group

    Neonates with univentricular physiology

    Treatment: Esophageal manometry catheter at various PEEP levels and tidal volumes

  • Biventricular physiologyOther group

    Neonates with biventricular physiology

    Treatment: Esophageal manometry catheter at various PEEP levels and tidal volumes

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Record updated
16 July 2025