Intraoperative Protective Ventilation and Postoperative Pulmonary Complications
Completed · Not applicable
Conditions studied: Complication of Ventilation Therapy, Postoperative Respiratory Complications
In brief
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.
Key facts
- Study ID
- NCT02671721
- Run by
- Massachusetts General Hospital
- People needed
- 40
- Starts
- 2016-06-01
- Expected to finish
- 2017-06-01
- Last updated by the study team
- 2019-02-08
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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