Clinical Trials Directory

Trials / Completed

CompletedNCT05257525

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
10 (actual)
Sponsor
The Hospital for Sick Children · Academic / Other
Sex
All
Age
28 Days
Healthy volunteers
Not accepted

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.

Detailed description

This research study is being done so that investigators can understand the complex interactions between the heart, the lungs and the chest wall after heart surgery. Understanding this may guide future care that can help patients with their recovery from heart surgery. The heart and lungs work together to make sure the body has the oxygen-rich blood it needs to function properly. The chest wall protects the heart, lungs, and other important organs. Investigators would like to learn how a patient's chest wall contributes to the heart and lungs interaction when the chest is left open after heart surgery. Investigators will be using a device called an esophageal pressure catheter to estimate the pressure that is transmitted to the lungs and heart, called pleural pressure. Previous research has shown that this pressure measurement is used to adjust the breathing machine for patients with lung diseases. Measuring the pressure transmitted to the lungs and heart after heart surgery and delayed chest wall closure may help investigators understand how the chest wall contributes to the heart and lung interaction.

Conditions

Interventions

TypeNameDescription
OTHEREsophageal manometry catheter at various PEEP levels and tidal volumesParticipants 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.

Timeline

Start date
2022-08-26
Primary completion
2023-10-26
Completion
2024-01-08
First posted
2022-02-25
Last updated
2025-07-16

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT05257525. Inclusion in this directory is not an endorsement.