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The goal of this study is to compare two continuous positive airway pressure (CPAP) settings on heart and lung function in patients with severe obesity after anesthesia. The main questions it aims to answer are:
Participants will undergo monitoring of their intrathoracic pressure using an esophageal catheter. In the recovery area after anesthesia, participants will receive two CPAP settings, each for 20 minutes.
The current proposed crossover study is a single center, open-label clinical trial in patients who have severe obesity (defined by body mass index greater than or equal to 40 kg/m2) and are recovering from anesthesia. The primary aim is to describe the difference cardiopulmonary function between two settings for continuous positive airway pressure (CPAP), using electrical impedance tomography (EIT), transthoracic echocardiography, and esophageal pressure monitoring to measure response. The secondary aim is to determine whether the location of adipose tissue modifies responses to CPAP settings.
The study protocol consists of placing an esophageal catheter to monitor intrathoracic pressure in the operating room when the participant is under anesthesia. In the post-anesthesia care unit, participants will receive two CPAP settings, in random order, for 20 minutes each. One setting is a recruitment maneuver and CPAP set to the level of end-expiratory pressure (intrathoracic pressure). Another setting is a CPAP set to home levels (if known) or 8-10 cmH20 if not on home CPAP. There will be a 10 minute washout period between interventions. Investigators will monitor airway and esophageal pressure, ventilation with electrical impedance tomography, right heart function with transthoracic echocardiography, and abdominal muscle contraction with ultrasound. Waist and hip circumference will be measured prior to CPAP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Recruitment and ITP-CPAP | Experimental | Recruitment maneuver followed by CPAP set to intrathoracic pressure (ITP) |
|
| Standard CPAP | Active Comparator | CPAP set to home level of CPAP (if known) or CPAP set to standard levels (8-10 cmH20) |
|
| Atmospheric pressure | Placebo Comparator | Breathing without CPAP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recruitment/ITP-CPAP (Intervention A) | Device | Participant will receive a recruitment maneuver followed by CPAP set to the level of end-expiratory esophageal pressure (measured during atmospheric pressure breathing). The intervention will last for 20 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| End expiratory lung impedance | End expiratory lung impedance, a surrogate of end expiratory lung volume, measured from EIT | Assessed at baseline during atmospheric pressure breathing (no CPAP), assessed at the end of intervention A (20 minutes), assessed at end of intervention B (20 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Regional lung ventilation | % of relative ventilation to ventral and dorsal lung regions, measured from EIT | Assessed at baseline during atmospheric pressure breathing (no CPAP), assessed at the end of intervention A (20 minutes), assessed at end of intervention B (20 minutes) |
| Right ventricular function |
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Inclusion Criteria:
Adult patients (≥ 18 years old) scheduled for elective non-cardiothoracic surgery requiring general anesthesia with an endotracheal tube
Planned admission to the post-anesthesia care unit (PACU) after surgery
BMI ≥ 40 kg/m2
At the time of baseline measurements in the PACU, patients meet the following criteria:
Exclusion Criteria:
Pregnancy, suspected pregnancy or less than six weeks postpartum Known or current pneumothorax
Hemodynamic instability at the time of study assessment in the PACU defined as:
Respiratory insufficiency in PACU defined as:
Known chronic lung disease requiring supplemental oxygen at home
Known systolic heart dysfunction (left ventricular ejection fraction ≤ 30%)
Contraindication for esophageal catheter placement:
Contraindication for electrical impedance tomograph belt placement:
Concern for study inclusion by the perioperative nurse or anesthesia team
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Timothy Gaulton, MD, MSc | Contact | 617-643-7733 | tgaulton@mgh.harvard.edu | |
| Lorenzo Berra | Contact | lberra@mgh.harvard.edu |
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All data analysis codes developed for this project in MATLAB (for electrical impedance tomography) or R will be thoroughly documented and made openly accessible on GitHub. We will make de-identified data available via the vivli platform (http://vivli.org/), non-profit clinical research data sharing platform. All data will be shared publicly under a data use agreement through a managed access process.
Individual participant data and supporting information will be available after data analysis and manuscript publication.
Individual participant data can be accessed from a data use agreement once data is uploaded on vivil
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| ID | Term |
|---|---|
| D056128 | Obesity, Abdominal |
| D020181 | Sleep Apnea, Obstructive |
| D001261 | Pulmonary Atelectasis |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| Standard CPAP (Intervention B) | Device | Participant will receive their home CPAP (if on CPAP at home) or CPAP at 8-10 cmH20 (if not on CPAP at home or no known diagnosis of OSA). The intervention will last for 20 minutes. |
|
| Atmospheric Pressure | Device | Participant will breathe at atmosphere pressure (no CPAP) with supplemental oxygen as needed per clinical guidance. |
|
Defined by tricuspid annular plane systolic excursion, measured from transthoracic echocardiogram |
| Assessed at baseline during atmospheric pressure breathing (no CPAP), assessed at the end of intervention A (20 minutes), assessed at end of intervention B (20 minutes) |
| Mean pulmonary artery pressure | Defined by pulmonary artery acceleration time using transthoracic echocardiography | Assessed at baseline during atmospheric pressure breathing (no CPAP), assessed at the end of intervention A (20 minutes), assessed at end of intervention B (20 minutes) |
| Inspiratory effort | delta esophageal pressure, calculated as the negative deflections of esophageal pressure from the onset of inspiration and Pressure time product, the time-based integral of the Pes tracing during inspiration, per breath and per minute, measured from esophageal pressure tracing | Assessed at baseline during atmospheric pressure breathing (no CPAP), assessed at the end of intervention A (20 minutes), assessed at end of intervention B (20 minutes) |
| Abdominal muscle thickness | Thickness of the muscles involved in expiration, measured by ultrasound - lateral abdominal wall muscles (external oblique, internal oblique, and transversus abdominis muscles) | Assessed at baseline during atmospheric pressure breathing (no CPAP), assessed at the end of intervention A (20 minutes), assessed at end of intervention B (20 minutes) |
| Respiratory rate | breath per minute | Assessed at baseline during atmospheric pressure breathing (no CPAP), assessed at the end of intervention A (20 minutes), assessed at end of intervention B (20 minutes) |
| Oxygen saturation | Defined from pulse oximetry | Assessed at baseline during atmospheric pressure breathing (no CPAP), assessed at the end of intervention A (20 minutes), assessed at end of intervention B (20 minutes) |
| Systemic blood pressure | Defined by non-invasive blood pressure measurement | Assessed at baseline during atmospheric pressure breathing (no CPAP), assessed at the end of intervention A (20 minutes), assessed at end of intervention B (20 minutes) |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D008171 | Lung Diseases |