Clinical trial NCT05257525: Impact of Chest Wall Mechanics on Lung and Cardiovascular Function During Delayed Sternal Closure
Official title: Impact of Chest Wall Mechanics on Lung and Cardiovascular Function During Delayed Sternal Closure
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Palliation of Congenital Heart Diseases
Cardiopulmonary Bypass
Chest Wall Mechanics
Neonatal Delayed Sternal Closure
Keywords: chest wall mechanics
congenital heart disease
neonates
delayed sternal closure
cardiopulmonary bypass
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Children's Hospital Los Angeles
First posted: 2022-02-25
Enrollment: 40
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Percentage of patients with successful insertion and measurement of esophageal pressures
timeFrame: Immediately prior to chest closure and repeated measurements after chest closure
Secondary outcomes:
measure: End-inspiratory and end-expiratory transpulmonary pressure
timeFrame: Prior to and immediately after sternal chest wall closure procedure
measure: Transmural systolic pressures
timeFrame: Prior to and immediately after sternal chest wall closure procedure
measure: Transmural diastolic pressures
timeFrame: Prior to and immediately after sternal chest wall closure procedure
measure: Chest wall and lung compliance
timeFrame: Prior to and immediately after sternal chest wall closure procedure
measure: Changes in transmural pressures
timeFrame: Prior to and immediately after sternal chest wall closure procedure
measure: Duration of inotropic support
timeFrame: At 30 days post-operation or discharge (whichever comes first)
measure: Duration of support with supplemental oxygen
timeFrame: At 30 days post-operation or discharge (whichever comes first)
measure: Length ICU Stay
timeFrame: At 30 days post-operation or discharge (whichever comes first)
measure: Duration of mechanical ventilation
timeFrame: At 30 days post-operation or discharge (whichever comes first)
measure: Length of Hospital Stay
timeFrame: At 30 days post-operation or discharge (whichever comes first)
measure: Mortality
timeFrame: At 30 days post-operation or discharge (whichever comes first)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Luciana Rodriguez Guerineau, MD
role: PRINCIPAL_INVESTIGATOR
References: