Intraoperative Protective Ventilation and Postoperative Pulmonary Complications
United States40 participantsStarted 2016-06
Plain-language summary
The purpose of this pilot study is to identify the optimal way to ventilate patients during abdominal surgery in order to reduce the amount of post-operative pulmonary complications in patients at moderate and high-risk for them.
Who can participate
Age range18 Years ā 100 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults ( 18 years) scheduled for elective surgery expected to last 2 h,
* elective intraperitoneal abdominal or pelvic surgery including: gastric; biliary; pancreatic; hepatic; major bowel, ovarian, renal tract, bladder, and prostatic; radical hysterectomy; and pelvic exenteration;
* at least intermediate risk of PPCs defined by a risk score 26
Exclusion Criteria:
* Inability or refusal to provide consent
* Refusal of clinicians caring for patient to follow the protocol
* Participation in interventional investigation within 30 days of the time of the study
* Pregnancy
* Emergency surgery
* Severe obesity (above Class I, BMI 35)
* Significant lung disease: any diagnosed or treated respiratory condition that (a) requires home oxygen therapy or non-invasive ventilation, (b) severely limits exercise tolerance to \<4 METs (e.g. patients unable to do light housework, walk flat at 4 miles/h or climb one flight of stairs), or (c) required previous lung surgery80
* Significant heart disease: cardiac conditions that limit exercise tolerance to \<4 METs
* Renal failure: peritoneal or hemodialysis requirement or preoperative creatinine 2 mg/dL;
* Neuromuscular disease that impairs ability to ventilate without assistance
* Severe chronic liver disease (Child-Pugh Score of 10 -15)
* Sepsis
* Malignancy or other irreversible condition for which 6-month mortality is estimated 50%
* Bone marrow transplant.