CompletedNot Applicable

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

Canada10 participantsStarted 2022-08-26

Plain-language 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.

Who can participate

Age range

28 Days

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of patients with successful insertion and measurement of esophageal pressures

Timeframe: Immediately prior to chest closure and repeated measurements after chest closure

Trial details

NCT IDNCT05257525

SponsorThe Hospital for Sick Children

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-26

View on ClinicalTrials.gov More Palliation of Congenital Heart Diseases trials