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Completed

NCT Number: NCT05257525

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

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.

Primary outcomes

  1. Percentage of patients with successful insertion and measurement of esophageal pressures

    Time frame: 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 outcomes

  1. End-inspiratory and end-expiratory transpulmonary pressure

    Time frame: Prior to and immediately after sternal chest wall closure procedure

    cmH20

  2. Transmural systolic pressures

    Time frame: Prior to and immediately after sternal chest wall closure procedure

    mmHg

  3. Transmural diastolic pressures

    Time frame: Prior to and immediately after sternal chest wall closure procedure

    mmHg

  4. Chest wall and lung compliance

    Time frame: Prior to and immediately after sternal chest wall closure procedure

    mL/cmH20

  5. Changes in transmural pressures

    Time frame: Prior to and immediately after sternal chest wall closure procedure

    mmHg

  6. Duration of inotropic support

    Time frame: At 30 days post-operation or discharge (whichever comes first)

    Hours

  7. Duration of support with supplemental oxygen

    Time frame: At 30 days post-operation or discharge (whichever comes first)

    Days

  8. Length ICU Stay

    Time frame: At 30 days post-operation or discharge (whichever comes first)

    Days

  9. Duration of mechanical ventilation

    Time frame: At 30 days post-operation or discharge (whichever comes first)

    Hours

  10. Length of Hospital Stay

    Time frame: At 30 days post-operation or discharge (whichever comes first)

    Days

  11. Mortality

    Time frame: At 30 days post-operation or discharge (whichever comes first)

    Yes/No

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

  • Children's Hospital Los Angeles

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Feb 25, 2022
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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