COMPLETED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Postoperative pulmonary complications (PPCs) are a major cause of morbidity and mortality in surgical patients. National estimates suggest 1,062,000 PPCs per year, with 46,200 deaths, and 4.8 million additional days of hospitalization. The objective of the study is to develop and implement perioperative strategies to eliminate PPCs in abdominal surgery, the field with the largest absolute number of PPCs. We will conduct a randomized controlled pragmatic trial in 750 studied participants. The effectiveness of an individualized perioperative anesthesia-centered bundle will be compared to the usual anesthetic care in patients receiving open abdominal surgery. At the end of this project, the investigators expect to change clinical practice by establishing a new and clinically feasible anesthesia-centered strategy to reduce perioperative lung morbidity. The research will be conducted across 14 US academic centers, and will be funded by the National Institute of Health.

Official Title

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

Quick Facts

Study Start:2020-01-27
Study Completion:2023-07-13
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT04108130

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults (\>=18 years) scheduled for elective surgery with expected duration \>=2 hours
  2. * Open abdominal surgery including: gastric, biliary, pancreatic, hepatic, major bowel, ovarian, renal tract, bladder, prostatic, radical hysterectomy, and pelvic exenteration
  3. * Intermediate or high risk of PPCs defined by an ARISCAT (Assess Respiratory Risk in Surgical Patients in Catalonia Score) risk score\>=26
  1. * Inability or refusal to provide consent
  2. * 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.
  3. * Participation in any interventional research study within 30 days of the time of the study.
  4. * Previous surgery within 30 days prior to this study.
  5. * Pregnancy
  6. * Emergency surgery
  7. * Severe obesity (above Class I, BMI\>=35 kg/m2)
  8. * Significant lung disease: any diagnosed or treated respiratory condition that (a) requires home oxygen therapy or non-invasive ventilation (except nocturnal treatment of sleep apnea without supplemental oxygen), (b) severely limits exercise tolerance to \<4 metabolic equivalents (METs) (e.g., patients unable to do light housework, walk flat at 4 miles/h or climb one flight of stairs), (c) required previous lung surgery, or (d) includes presence of severe pulmonary emphysema or bullae
  9. * Significant heart disease: cardiac conditions that limit exercise tolerance to \<4 METs
  10. * Renal failure: peritoneal or hemodialysis requirement or preoperative creatinine \>=2 mg/dL
  11. * Neuromuscular disease that impairs ability to ventilate without assistance
  12. * Severe chronic liver disease (Child-Turcotte-Pugh Score \>9, Appendix I)
  13. * Sepsis
  14. * Malignancy or other irreversible condition for which 6-month mortality is estimated \>=20%
  15. * Bone marrow transplant

Contacts and Locations

Principal Investigator

Marcos F Vidal Melo, MD
PRINCIPAL_INVESTIGATOR
Columbia University

Study Locations (Sites)

University of California - San Francisco
San Francisco, California, 94115
United States
Stanford University
Stanford, California, 94305
United States
University of Colorado, Anschutz Medical Campus
Aurora, Colorado, 80045
United States
South Florida Veterans Affairs Foundation for Research and Education, Inc.
Miami, Florida, 33125
United States
Northwestern University
Evanston, Illinois, 60208
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
Beth Israel Deaconess Hospital
Boston, Massachusetts, 02215
United States
Univerisity of Massachusetts Amherst Center
Worcester, Massachusetts, 01655
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198
United States
Montefiore Hospital
Bronx, New York, 10467
United States
Columbia University Medical Center
New York, New York, 10032
United States
Memorial Sloan Kettering
New York, New York, 10065
United States
University of Rochester
Rochester, New York, 14642
United States
Duke University
Durham, North Carolina, 27710
United States

Collaborators and Investigators

Sponsor: Columbia University

  • Marcos F Vidal Melo, MD, PRINCIPAL_INVESTIGATOR, Columbia University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-01-27
Study Completion Date2023-07-13

Study Record Updates

Study Start Date2020-01-27
Study Completion Date2023-07-13

Terms related to this study

Additional Relevant MeSH Terms

  • Postoperative Pulmonary Complications