Palliation of Congenital Heart DiseasesNCT05257525
Impact of Chest Wall Mechanics on Lung and Cardiovascular Function During Delayed Sternal Closure
A study testing Esophageal manometry catheter at various PEEP levels and tidal volumes in people with Palliation of Congenital Heart Diseases and Cardiopulmonary Bypass, run by The Hospital for Sick Children at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- Palliation of Congenital Heart Diseases, Cardiopulmonary Bypass, Chest Wall Mechanics
- What is being tested?
- Esophageal manometry catheter at various PEEP levels and tidal volumes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 26 Aug 2022to 8 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to describe chest wall mechanics during delayed sternal closure (DSC) in neonates following cardiopulmonary bypass or palliation of congenital heart diseases.
Read the 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.
- Conditions
- Palliation of Congenital Heart Diseases, Cardiopulmonary Bypass, Chest Wall Mechanics, Neonatal Delayed Sternal Closure
- Being tested
- Esophageal manometry catheter at various PEEP levels and tidal volumes
- Keywords
- chest wall mechanics, congenital heart disease, neonates, delayed sternal closure, cardiopulmonary bypass
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esophageal manometry catheter at various PEEP levels and tidal volumesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Univentricular physiology | Other | Neonates with univentricular physiology Receives: Other: Esophageal manometry catheter at various PEEP levels and tidal volumes |
| Biventricular physiology | Other | Neonates with biventricular physiology Receives: Other: Esophageal manometry catheter at various PEEP levels and tidal volumes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately prior to chest closure and repeated measurements after chest closure
Secondary outcomes (11)
End-inspiratory and end-expiratory transpulmonary pressure
cmH20
Measured: Prior to and immediately after sternal chest wall closure procedure
Transmural systolic pressures
mmHg
Measured: Prior to and immediately after sternal chest wall closure procedure
Transmural diastolic pressures
mmHg
Measured: Prior to and immediately after sternal chest wall closure procedure
Chest wall and lung compliance
mL/cmH20
Measured: Prior to and immediately after sternal chest wall closure procedure
Changes in transmural pressures
mmHg
Measured: Prior to and immediately after sternal chest wall closure procedure
Duration of inotropic support
Hours
Measured: At 30 days post-operation or discharge (whichever comes first)
Duration of support with supplemental oxygen
Days
Measured: At 30 days post-operation or discharge (whichever comes first)
Length ICU Stay
Days
Measured: At 30 days post-operation or discharge (whichever comes first)
Duration of mechanical ventilation
Hours
Measured: At 30 days post-operation or discharge (whichever comes first)
Length of Hospital Stay
Days
Measured: At 30 days post-operation or discharge (whichever comes first)
Mortality
Yes/No
Measured: At 30 days post-operation or discharge (whichever comes first)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start26 Aug 2022
- Primary completion26 Oct 2023
- Study completion8 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palliation of Congenital Heart DiseasesStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Los Angeles
- Responsible party
- Principal investigator, Luciana Rodriguez Guerineau, The Hospital for Sick Children
- Investigators
- Luciana Rodriguez Guerineau, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05257525
- Sponsor's protocol ID
- 1000075860
- Status last verified
- Jul 2025
- First submitted
- 25 Jan 2022
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Chest Wall Mechanics on Lung and Cardiovascular Function During Delayed Sternal Closure
- ClinicalTrials.gov ID
- NCT05257525
- Acronym / sponsor ID
- 1000075860
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Children's Hospital Los Angeles
- Study start
- 26 Aug 2022 (actual)
- Primary completion
- 26 Oct 2023 (actual)
- Study completion
- 8 Jan 2024 (actual)
- First posted
- 25 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Univentricular physiology | Other | Other: Esophageal manometry catheter at various PEEP levels and tidal volumesNeonates with univentricular physiology |
| Biventricular physiology | Other | Other: Esophageal manometry catheter at various PEEP levels and tidal volumesNeonates with biventricular physiology |
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Esophageal manometry catheter at various PEEP levels and tidal volumesParticipants 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, Univentricular physiology |
Primary outcome
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.
11 secondary outcomes
End-inspiratory and end-expiratory transpulmonary pressure
Time frame: Prior to and immediately after sternal chest wall closure procedure
Transmural systolic pressures
Time frame: Prior to and immediately after sternal chest wall closure procedure
Transmural diastolic pressures
Time frame: Prior to and immediately after sternal chest wall closure procedure
Chest wall and lung compliance
Time frame: Prior to and immediately after sternal chest wall closure procedure
Changes in transmural pressures
Time frame: Prior to and immediately after sternal chest wall closure procedure
Duration of inotropic support
Time frame: At 30 days post-operation or discharge (whichever comes first)
Duration of support with supplemental oxygen
Time frame: At 30 days post-operation or discharge (whichever comes first)
Length ICU Stay
Time frame: At 30 days post-operation or discharge (whichever comes first)
Duration of mechanical ventilation
Time frame: At 30 days post-operation or discharge (whichever comes first)
Length of Hospital Stay
Time frame: At 30 days post-operation or discharge (whichever comes first)
Mortality
Time frame: At 30 days post-operation or discharge (whichever comes first)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Palliation of Congenital Heart Diseases
Enrolling by invitationObservational study
International Multicenter Outcomes of Transcatheter Pulmonary Flow Restrictors in Congenital and Acquired Heart Disease
Congenital Heart Disease
Enrolling by invitation
Palliative Care Needs of Children With Rare Diseases and Their Families
Trisomy 13 Syndrome, Arthrogryposis Congenita Multiplex With Intestinal Atresia
Active, not recruitingPhase 1
Intramyocardial Injection of Autologous UCB-MNC During Fontan Surgery for SRV Dependent CHD
Congenital Heart Disease, SRV Dependent
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luciana Rodriguez Guerineau, MD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Esophageal manometry catheter at various PEEP levels and tidal volumes in people with Palliation of Congenital Heart Diseases and Cardiopulmonary Bypass, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with successful insertion and measurement of esophageal pressures (time frame: Immediately prior to chest closure and repeated measurements after chest closure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.