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

NCT05257525 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-07-16

No results posted yet for this study

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.

Conditions

  • Palliation of Congenital Heart Diseases
  • Cardiopulmonary Bypass
  • Chest Wall Mechanics
  • Neonatal Delayed Sternal Closure

Interventions

OTHER

Esophageal manometry catheter at various PEEP levels and tidal volumes

Participants will undergo placement of an esophageal manometry catheter before planned sternal closure. This catheter will be used to measure esophageal pressure which is a surrogate for pleural (intrathoracic) pressure. Esophageal pressure will then be used to estimate changes in respiratory system mechanics and hemodynamics following sternal closure and across different levels of positive end-expiratory pressure (PEEP) and tidal volumes.

Sponsors & Collaborators

Principal Investigators

  • Luciana Rodriguez Guerineau, MD · The Hospital for Sick Children

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-26
Primary Completion
2023-10-26
Completion
2024-01-08

Countries

  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05257525 on ClinicalTrials.gov