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

NCT05257525 | Completed DMC

• 1 other identifier: 1000075860
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• End-inspiratory and end-expiratory transpulmonary pressure

  Prior to and immediately after sternal chest wall closure procedure

• Transmural systolic pressures

  Prior to and immediately after sternal chest wall closure procedure

• Transmural diastolic pressures

  Prior to and immediately after sternal chest wall closure procedure

• Chest wall and lung compliance

  Prior to and immediately after sternal chest wall closure procedure

• Changes in transmural pressures

  Prior to and immediately after sternal chest wall closure procedure

Study Arms (2)

Univentricular physiology

OTHER

Neonates with univentricular physiology

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

Biventricular physiology

OTHER

Neonates with biventricular physiology

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

Interventions

Esophageal manometry catheter at various PEEP levels and tidal volumes OTHER

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.

Biventricular physiology; Univentricular physiology

Eligibility Criteria

• Age: Up to 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Children's Hospital Los Angeles: collaborator

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Tidal Volume

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Inspiratory Capacity; Vital Capacity; Total Lung Capacity; Lung Volume Measurements; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Luciana Rodriguez Guerineau, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: February 25, 2022
• Study Start: August 26, 2022
• Primary Completion: October 26, 2023
• Study Completion: January 8, 2024
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: 6 months after publication or starting January 2023, whichever comes first
• 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.

Locations

CA (1)