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An Anesthesia-Centered Bundle to Reduce Postoperative Pulmonary Complications: The PRIME-AIR Study (PRIME-AIR)

Overview

About this study

PRIME-AIR is a multicenter, prospective, controlled open-label parallel-group clinical trial to test the effect of an individualized perioperative anesthesia-centered bundle on the number and severity of postoperative pulmonary complications (PPCs). Eligible patients will be adults undergoing major open abdominal surgery with intermediate or high risk for developing PPCs. These represent a large population of abdominal surgery patients sustaining the relevance and generalizability of the study. We plan to study a total of 750 adult patients undergoing abdominal surgery with general anesthesia and mechanical ventilation. Patients will receive the intervention perioperatively and will be followed by hospital visits and a daily phone call until discharged home or until 7 days after surgery. Phone calls or hospital visits will also be done immediately after postoperative days 7, 30 and 90 to determine additional 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:

- Adults (≥ 18 years) scheduled for elective surgery with expected duration ≥ 2 hours

- Open abdominal surgery including: gastric, biliary, pancreatic, hepatic, major bowel, ovarian, renal tract, bladder, prostatic, radical hysterectomy, and pelvic
exenteration

- Intermediate or high risk of PPCs defined by an ARISCAT risk score ≥ 26

Exclusion Criteria:

- Inability or refusal to provide consent

- 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.

- Participation in any interventional research study within 30 days of the time of the study.

- Previous surgery within 30 days prior to this study.

- Pregnancy

- Emergency surgery

- Severe obesity (above Class I, BMI ≥ 35 kg/m^2)

- 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., patients unable to do light housework, walk flat at 4 miles/h or climb one flight of stairs);
  • required previous lung surgery; or
  • includes presence of severe pulmonary emphysema or bullae.

- 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-Turcotte-Pugh Score > 9)

- Sepsis

- Malignancy or other irreversible condition for which 6-month mortality is estimated ≥ 20%

- Bone marrow transplant

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 Contact

Rochester, Minn.

Mayo Clinic principal investigator

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

Closed for enrollment

Contact information:

Amy Amsbaugh R.R.T., L.R.T.

(507) 538-7538

Amsbaugh.Amy@mayo.edu

More information

Publications

  • Pneumoperitoneum and nonphysiological positioning required for robotic surgery increase cardiopulmonary risk because of the use of larger airway pressures (Paws) to maintain tidal volume (VT). However, the quantitative partitioning of respiratory mechanics and transpulmonary pressure (PL) during robotic surgery is not well described. We tested the following hypothesis: (1) the components of driving pressure (transpulmonary and chest wall components) increase in a parallel fashion at robotic surgical stages (Trendelenburg and robot docking); and (2) deep, when compared to routine (moderate), neuromuscular blockade modifies those changes in PLs as well as in regional respiratory mechanics. Read More on PubMed
  • The physiological concept, pathophysiological implications and clinical relevance and application of driving pressure and transpulmonary pressure to prevent ventilator-induced lung injury are discussed. Read More on PubMed
  • An intraoperative higher level of positive end-expiratory positive pressure (PEEP) with alveolar recruitment maneuvers improves respiratory function in obese patients undergoing surgery, but the effect on clinical outcomes is uncertain. Read More on PubMed
  • The effects of individualised perioperative lung-protective ventilation (based on the open-lung approach [OLA]) on postoperative complications is unknown. We aimed to investigate the effects of intraoperative and postoperative ventilatory management in patients scheduled for abdominal surgery, compared with standard protective ventilation. Read More on PubMed
  • In this study, we examined whether (1) positive end-expiratory pressure (PEEP) has a protective effect on the risk of major postoperative respiratory complications in a cohort of patients undergoing major abdominal surgeries and craniotomies, and (2) the effect of PEEP is differed by surgery type. Read More on PubMed
  • To evaluate the effects of intraoperative protective ventilation on major postoperative respiratory complications and to define safe intraoperative mechanical ventilator settings that do not translate into an increased risk of postoperative respiratory complications. Read More on PubMed
  • Lung protective ventilation strategies utilizing lower tidal volumes per predicted body weight (PBW) and positive end-expiratory pressure (PEEP) have been suggested to be beneficial in a variety of surgical populations. Recent clinical studies have used control groups ventilated with high tidal volumes without PEEP based on the assumption that this reflects current clinical practice. We hypothesized that ventilation strategies have changed over time, that most anesthetics in U.S. academic medical centers are currently performed with lower tidal volumes, and that most receive PEEP. Read More on PubMed
  • The role of positive end-expiratory pressure in mechanical ventilation during general anaesthesia for surgery remains uncertain. Levels of pressure higher than 0 cm H2O might protect against postoperative pulmonary complications but could also cause intraoperative circulatory depression and lung injury from overdistension. We tested the hypothesis that a high level of positive end-expiratory pressure with recruitment manoeuvres protects against postoperative pulmonary complications in patients at risk of complications who are receiving mechanical ventilation with low tidal volumes during general anaesthesia for open abdominal surgery. Read More on PubMed
  • Lung-protective ventilation with the use of low tidal volumes and positive end-expiratory pressure is considered best practice in the care of many critically ill patients. However, its role in anesthetized patients undergoing major surgery is not known. Read More on PubMed

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