The PRIME-AIR Study: Positive End-Expiratory Pressure, Recruitment, Incentive Spirometry, Muscle Relaxant Optimization, Preoperative Education, Postoperative Early Ambulation, Individualized, and Reinforced

Data Access NOTE: Please refer to the "Authorized Access" section below for information about how access to the data from this accession differs from many other dbGaP accessions.The PRIME-AIR study ("Positive end-expiratory pressure, Recruitment, Incentive spirometry, Muscle relaxant optimization, preoperative Education, postoperative early Ambulation, Individualized, and Reinforced") was a prospective multi-center randomized controlled pragmatic trial, with a blinded assessor, to compare post-operative pulmonary complications (PPCs) in patients with an individualized anesthetic-centered intervention (including individualized mechanical ventilation positive end-expiratory pressure (PEEP) management to maximize respiratory system compliance and minimize driving pressures, a neuromuscular agent and subsequent reversal, and post-operative lung expansion and early mobilization) versus usual care.]]>
Inclusion Criteria:Participants must meet all of the following inclusion criteria to participate in this study: Adults at least 18 years of age on date of surgery;Scheduled for elective surgery;Planned operation is open abdominal surgery including: gastric, biliary, pancreatic, hepatic, major bowel, ovarian, renal tract, bladder, prostatic, hysterectomy, and pelvic exenteration;Surgery anticipated to last ≥ 2 hours; and,At least Intermediate risk of PPCs defined by an ARISCAT risk score >=26 on the day of surgery.Exclusion Criteria:Participants are excluded from the study if they meet any of the following criteria:Participant inability to provide consent (for cognitive or other reasons);Anticipated inability or significant difficulty to perform any study interventions, including incentive spirometry, ambulation and/or maintaining follow-up contact with study personnel for up to 90 days after the date of surgery;Known participation in any interventional research study within the past 30 days. (This refers to interventions that would result in potential physiological effects such as drug studies, not observational studies or noninvasive interventions without physiological effect);Previous surgery within 30 days prior to this study. (Any surgical procedure. Participants undergoing endoscopic procedures can be included in the study);Pregnancy;Emergency surgery (Any surgical procedure labelled as urgent or emergent);Severe obesity (above Class I, Body Mass Index, BMI, >=35 kg/m2);Significant lung disease: any diagnosed or treated respiratory condition that:requires home oxygen therapy or non-invasive ventilation (except nocturnal treatment of sleep apnea without supplemental oxygen), severely limits exercise tolerance to <4 METs (e.g., participants unable to do light housework, walk flat at 4 miles/h or climb one flight of stairs),required previous lung surgery, orincludes presence of severe pulmonary emphysema or bullae. (Lung disease with increased risk of pneumothorax – bullae, severe emphysema, bronchopleural fistulae; Previous lung surgeries would include all types of lung resection surgery);Significant heart disease: cardiac conditions that limit exercise tolerance to <4 METs; Renal failure: peritoneal or hemodialysis requirement or preoperative creatinine >=2 mg/dL;Severe chronic liver disease (Child-Turcotte-Pugh Score >9, see appendix);Neuromuscular disease that impairs ability to ventilate without assistance;Malignancy or other irreversible condition for which 6-month mortality is estimated >=20%;Bone marrow transplant; or,Current Sepsis: life-threatening organ dysfunction caused by a dysregulated host response to infection. Organ dysfunction is defined by an acute increase in the Sequential [Sepsis-related] Organ Failure Assessment (SOFA) score of 2 points (see appendix).Pulmonary hypertension]]>
The study opened to enrollment in January, 2020. Enrollment was suspended in March, 2020, because of the COVID-19 pandemic, and reopened in July, 2020. Enrollment was completed in April, 2023.]]>