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

The Hospital for Sick Children

Status: Active, not recruiting

Conditions: Palliation of Congenital Heart Diseases; Cardiopulmonary Bypass; Neonatal Delayed Sternal Closure; Chest Wall Mechanics

Treatments: Other: Esophageal manometry catheter at various PEEP levels and tidal volumes

Study type: Interventional

Funder types: Other

Identifiers

NCT05257525

1000075860

Details and patient eligibility

About

This study aims to describe chest wall mechanics during delayed sternal closure (DSC) in neonates following cardiopulmonary bypass or palliation of congenital heart diseases.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: Under 28 days old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Univentricular physiology

Other group

Description:

Neonates with univentricular physiology

Treatment:

Other: Esophageal manometry catheter at various PEEP levels and tidal volumes

Biventricular physiology

Other group

Description:

Neonates with biventricular physiology

Treatment:

Other: Esophageal manometry catheter at various PEEP levels and tidal volumes