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CPAP in Patients With Severe Obesity After Anesthesia

ConditionsObesity, AbdominalAnesthesia MorbidityApnea, Obstructive SleepAtelectases, Postoperative PulmonaryVentilator Lung
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital

About this trial

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:

1. Does a recruitment maneuver and CPAP set to intrathoracic pressure (ITP) improve cardiopulmonary function compared to standard CPAP settings in patients with severe obesity after anesthesia? 2. Does the location of adipose tissue influence the response to CPAP settings in patients with severe obesity after anesthesia?

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.

* Intervention 1: Recruitment maneuver and CPAP will set to the level of intrathoracic pressure * Intervention 2: CPAP set to home settings (if OSA is present) or between 8-10 cmH20 (if OSA is not present).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Receiving ≤ 6 liters of supplemental nasal cannula oxygen

Disqualifiers

Pregnancy, suspected pregnancy or less than six weeks postpartum Known or current pneumothorax

systolic blood pressure <90 mmHg or >180 mmHg

mean blood pressure <60 or >130 mmHg

Any use of intravenous vasoactive agent

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Recruitment and ITP-CPAPExperimental treatment 1 intervention
Group B: Standard CPAPActive comparator 1 intervention
Group C: Atmospheric pressurePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

End expiratory lung impedance

End expiratory lung impedance, a surrogate of end expiratory lung volume, measured from EIT

Time frame
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)

Secondary outcomes

1

Regional lung ventilation

% of relative ventilation to ventral and dorsal lung regions, measured from EIT

Time frame
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)
2

Right ventricular function

Defined by tricuspid annular plane systolic excursion, measured from transthoracic echocardiogram

Time frame
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)
3

Mean pulmonary artery pressure

Defined by pulmonary artery acceleration time using transthoracic echocardiography

Time frame
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)
4

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

Time frame
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)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

Source ClinicalTrials.gov

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