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

Not Applicable

Active, not recruiting

• Conditions: Chest Wall Mechanics; Neonatal Delayed Sternal Closure; Palliation of Congenital Heart Diseases; Cardiopulmonary Bypass
• Interventions: Other: Esophageal manometry catheter at various PEEP levels and tidal volumes

• Registration Number: NCT05257525
• Lead Sponsor: The Hospital for Sick Children

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.

Study Timeline

• Study First Submitted: 2022-01-25
• Study First Submitted QC: 2022-02-17
• Study First Posted: 2022-02-25
• Study Start: 2022-08-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-05
• Last Update Posted: 2024-01-09
• Primary Completion: 2024-04
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Univentricular physiology	Esophageal manometry catheter at various PEEP levels and tidal volumes	Neonates with univentricular physiology
Biventricular physiology	Esophageal manometry catheter at various PEEP levels and tidal volumes	Neonates with biventricular physiology

Primary Outcome Measures

Name	Time	Method
Percentage of patients with successful insertion and measurement of esophageal pressures	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.

Secondary Outcome Measures

Name	Time	Method
Transmural diastolic pressures	Prior to and immediately after sternal chest wall closure procedure	mmHg
Chest wall and lung compliance	Prior to and immediately after sternal chest wall closure procedure	mL/cmH20
Changes in transmural pressures	Prior to and immediately after sternal chest wall closure procedure	mmHg
Duration of inotropic support	At 30 days post-operation or discharge (whichever comes first)	Hours
Mortality	At 30 days post-operation or discharge (whichever comes first)	Yes/No
Length ICU Stay	At 30 days post-operation or discharge (whichever comes first)	Days
Duration of mechanical ventilation	At 30 days post-operation or discharge (whichever comes first)	Hours
Length of Hospital Stay	At 30 days post-operation or discharge (whichever comes first)	Days
End-inspiratory and end-expiratory transpulmonary pressure	Prior to and immediately after sternal chest wall closure procedure	cmH20
Transmural systolic pressures	Prior to and immediately after sternal chest wall closure procedure	mmHg
Duration of support with supplemental oxygen	At 30 days post-operation or discharge (whichever comes first)	Days

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada