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| Name | Class |
|---|---|
| Children's Hospital Los Angeles | OTHER |
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This study aims to describe chest wall mechanics during delayed sternal closure (DSC) in neonates following cardiopulmonary bypass or palliation of congenital heart diseases.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Univentricular physiology | Other | Neonates with univentricular physiology |
|
| Biventricular physiology | Other | Neonates with biventricular physiology |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luciana Rodriguez Guerineau, MD | The Hospital for Sick Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hospital for Sick Children | Toronto | Ontario | Canada |
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.
6 months after publication or starting January 2023, whichever comes first
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.
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| 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) |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D013990 | Tidal Volume |
| ID | Term |
|---|---|
| D007320 | Inspiratory Capacity |
| D014797 | Vital Capacity |
| D014109 | Total Lung Capacity |
| D008176 | Lung Volume Measurements |
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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