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

Cardiopulmonary Bypass Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05257525
• Other study ID #: 1000075860
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: April 2024

Study information

• Verified date: January 2024
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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).

Related Conditions & MeSH terms

• Cardiopulmonary Bypass
• Heart Defects, Congenital
• Heart Diseases

Intervention

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.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Children's Hospital Los Angeles

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with successful insertion and measurement of esophageal pressures	Investigators hypothesize that successful esophageal catheter placement and measurement of Pes (full data set) will occur in =80% of enrolled subjects.	Immediately prior to chest closure and repeated measurements after chest closure
Secondary	End-inspiratory and end-expiratory transpulmonary pressure	cmH20	Prior to and immediately after sternal chest wall closure procedure
Secondary	Transmural systolic pressures	mmHg	Prior to and immediately after sternal chest wall closure procedure
Secondary	Transmural diastolic pressures	mmHg	Prior to and immediately after sternal chest wall closure procedure
Secondary	Chest wall and lung compliance	mL/cmH20	Prior to and immediately after sternal chest wall closure procedure
Secondary	Changes in transmural pressures	mmHg	Prior to and immediately after sternal chest wall closure procedure
Secondary	Duration of inotropic support	Hours	At 30 days post-operation or discharge (whichever comes first)
Secondary	Duration of support with supplemental oxygen	Days	At 30 days post-operation or discharge (whichever comes first)
Secondary	Length ICU Stay	Days	At 30 days post-operation or discharge (whichever comes first)
Secondary	Duration of mechanical ventilation	Hours	At 30 days post-operation or discharge (whichever comes first)
Secondary	Length of Hospital Stay	Days	At 30 days post-operation or discharge (whichever comes first)
Secondary	Mortality	Yes/No	At 30 days post-operation or discharge (whichever comes first)