The Hospital for Sick Children
Toronto, Ontario, Canada
NCT Number: NCT05257525
This study aims to describe chest wall mechanics during delayed sternal closure (DSC) in neonates following cardiopulmonary bypass or palliation of congenital heart diseases.
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All sexes
Interventional
Not applicable
Toronto, Ontario, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Immediately prior to chest closure and repeated measurements after chest closure
Investigators hypothesize that successful esophageal catheter placement and measurement of Pes (full data set) will occur in ≥80% of enrolled subjects.
Time frame: Prior to and immediately after sternal chest wall closure procedure
cmH20
Time frame: Prior to and immediately after sternal chest wall closure procedure
mmHg
Time frame: Prior to and immediately after sternal chest wall closure procedure
mmHg
Time frame: Prior to and immediately after sternal chest wall closure procedure
mL/cmH20
Time frame: Prior to and immediately after sternal chest wall closure procedure
mmHg
Time frame: At 30 days post-operation or discharge (whichever comes first)
Hours
Time frame: At 30 days post-operation or discharge (whichever comes first)
Days
Time frame: At 30 days post-operation or discharge (whichever comes first)
Days
Time frame: At 30 days post-operation or discharge (whichever comes first)
Hours
Time frame: At 30 days post-operation or discharge (whichever comes first)
Days
Time frame: At 30 days post-operation or discharge (whichever comes first)
Yes/No
The Hospital for Sick Children
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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