A Study Comparing a Protective Ventilation Plan with Higher versus Lower Positive End Expiratory Pressure During General Anesthesia in Surgery for Obese Patients
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 14-005465
NCT ID: NCT02148692
Sponsor Protocol Number: ANE-PROBESE
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 |
|
More information
Publications
Publications are currently not available