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New anesthesia bundle cuts deadly lung complications in half?

NCT ID NCT04108130

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a set of anesthesia techniques could lower the risk of serious lung complications after open abdominal surgery. About 794 adults at high risk for lung problems took part across 14 US hospitals. The approach included personalized ventilation and fluid management to protect the lungs during and after surgery.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

794 people

The number who actually took part.

Started

Jan 2020

Finished

Jul 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 (Assess Respiratory Risk in Surgical Patients in Catalonia Score) 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/m2) * 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 * 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, Appendix I) * Sepsis * Malignancy or other irreversible condition for which 6-month mortality is estimated \>=20% * Bone marrow transplant

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Beth Israel Deaconess Hospital

    Boston, Massachusetts, 02215, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Duke University

    Durham, North Carolina, 27710, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Memorial Sloan Kettering

    New York, New York, 10065, United States

  • Montefiore Hospital

    The Bronx, New York, 10467, United States

  • Northwestern University

    Evanston, Illinois, 60208, United States

  • South Florida Veterans Affairs Foundation for Research and Education, Inc.

    Miami, Florida, 33125, United States

  • Stanford University

    Stanford, California, 94305, United States

  • Univerisity of Massachusetts Amherst Center

    Worcester, Massachusetts, 01655, United States

  • University of California - San Francisco

    San Francisco, California, 94115, United States

  • University of Colorado, Anschutz Medical Campus

    Aurora, Colorado, 80045, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198, United States

  • University of Rochester

    Rochester, New York, 14642, United States

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