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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiopulmonary Bypass; Palliation of Congenital Heart Diseases; Chest Wall Mechanics; Neonatal Delayed Sternal Closure
• Intervention / Treatment: Other: Esophageal manometry catheter at various PEEP levels and tidal volumes

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Luciana Rodriguez Guerineau, MD; Phone Number: 208019 416-813-7654; Email: luciana.rodriguezguerineau@sickkids.ca
• Study Contact Backup: Name: Eva Ta, MSc, RN; Phone Number: 305670 416-813-7654; Email: eva.ta@sickkids.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • The Hospital for Sick Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 4 weeks (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Univentricular physiology; Neonates with univentricular physiology	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.
Other: Biventricular physiology; Neonates with biventricular physiology	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Collaborators: Children's Hospital Los Angeles
• Investigators: Principal Investigator: Luciana Rodriguez Guerineau, MD, The Hospital for Sick Children

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: January 25, 2022
• First Submitted That Met QC Criteria: February 17, 2022
• First Posted (Actual): February 25, 2022

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 5, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: cardiopulmonary bypass; neonates; congenital heart disease; chest wall mechanics; delayed sternal closure
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: 1000075860

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

All de-identified individual participant data (IPD) that underlie results in a publication will be shared upon request. The study protocol, statistical analysis plan, informed consent form, and analytic code will be shared starting (6 months after publication or starting January 2023, whichever comes first) upon request in writing.

Requests for IPD will be reviewed by the study PI and SickKids institute. IPD will be provided to researchers interested in furthering academia and research development only. IPD requests may also be subjected to SickKids' institutional agreements/contracts. IPD mechanism of sharing and types of analysis/data shared will be directed and determined by SickKids' institutional research contracts requirements.

• IPD Sharing Time Frame: 6 months after publication or starting January 2023, whichever comes first
• IPD Sharing Access Criteria: Requests for IPD will be reviewed by the study PI and SickKids institute. IPD will be provided to researchers interested in furthering academia and research development only. IPD requests may also be subjected to SickKids' institutional agreements/contracts. IPD mechanism of sharing and types of analysis/data shared will be directed and determined by SickKids' institutional research contracts requirements.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No