A Study Comparing a Protective Ventilation Plan with Higher versus Lower Positive End Expiratory Pressure During General Anesthesia in Surgery for Obese Patients

Overview

About this study

The purpose of this study is to compare a ventilation strategy using higher levels of positive end expiratory pressure and recruitment maneuvers to one using lower levels of positive end expiratory pressure without recruitment maneuvers in obese patients at an intermediate-to-high risk for post surgery respiratory complications.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

Is scheduled for surgery under general anesthesia
Has intermediate-to-high risk for post operative pulmonary complications following surgery, according to the ARISCAT risk score (≥ 26)
BMI ≥ 35 kg/m2
Expected duration of surgery ≥ 2 h

Exclusion Criteria

Age < 18 years
Previous lung surgery (any)
Persistent hemodynamic instability, intractable shock (considered hemodynamically unsuitable for the study by the patient's managing physician)
History of previous severe chronic obstructive pulmonary disease (COPD) (non-invasive ventilation and/or oxygen therapy at home, repeated systemic corticosteroid therapy for acute exacerbations of COPD)
Recent immunosuppressive medication (patients receiving chemotherapy or radiation therapy up to two months prior to surgery)
Severe cardiac disease (New York Heart Association class III or IV, acute coronary syndrome or persistent ventricular tachyarrhythmias)
Invasive mechanical ventilation longer than 30 minutes (e.g., general anesthesia for surgery) within last 30 days
Pregnancy (excluded by anamneses and/or laboratory analysis)
Prevalent acute respiratory distress syndrome expected to require prolonged postoperative mechanical ventilation
Severe pulmonary arterial hypertension, defined as systolic pulmonary artery pressure > 40 mmHg
Intracranial injury or tumor
Neuromuscular disease (any)
Need for intraoperative prone or lateral decubitus position
Need for one-lung ventilation
Cardiac surgery
Neurosurgery
Planned reintubation following surgery
Enrolled in another interventional study
Refusal of informed consent

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Rochester, Minn. Mayo Clinic principal investigator Juraj Sprung, M.D., Ph.D.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

Juraj Sprung, M.D., Ph.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Clinical Trials