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Custom ventilation during surgery may cut lung risks

NCT ID NCT03884543

Disease control Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 personalized breathing machine setting during open abdominal surgery could prevent lung complications like pneumonia or respiratory failure. Over 1,400 patients at risk for lung problems were randomly assigned to either the personalized strategy or standard care. The approach aimed to keep the lungs open with the least pressure needed.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
individualized high PEEP ventilation strategy
What this could lead to
If successful, this could lead to a standard way to ventilate patients during open abdominal surgery to reduce lung complications.
What could go wrong
This trial is completed but results may not apply to all surgeries or patients. The strategy involves adjustments that may not work for everyone.

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

1,468 people

The number who actually took part.

Started

Apr 2019

Finished

Jun 2025

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 to 100 years

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: * Scheduled for open abdominal surgery * High or intermediate risk for postoperative pulmonary complications according to ARISCAT score \[J.Canet et al, Anesthesiology 2010;113\] * General anesthesia Exclusion Criteria: * Laparoscopic surgery * Surgery in prone or lateral position * Combined procedure with open abdominal and intrathoracic surgery * Body mass index \> 40 kg/m2; * Reported pregnancy; * Mechanical ventilation \> than 30 minutes (e.g., in cases of general anesthesia because of surgery) within last 30 days; * Any major previous lung surgery; * History of previous severe chronic obstructive pulmonary disease (COPD) GOLD III or IV, or with (noninvasive) ventilation and/or oxygen therapy at home; * (previous) acute respiratory distress syndrome (ARDS); * Expected to require postoperative mechanical ventilation; * Persistent hemodynamic instability or intractable shock; * Severe cardiac disease (New York Heart Association class III or IV, or acute coronary syndrome, or persistent ventricular tachyarrhythmia's); * Consented for another interventional study during anesthesia or refusal to participate in the study

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As listed by the trial registrant

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

Postoperative respiratory complication

Contacts and locations

Locations

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    Amsterdam, Netherlands

  • Albert Schweitzer Ziekenhuis

    Dordrecht, Netherlands

  • Amsterdam UMC location VUmc

    Amsterdam, Netherlands

  • Bermanntrost BG Klinikum Halle

    Halle, Germany

  • Bernhoven Hospital

    Uden, Netherlands

  • Erasmus Medisch Centrum

    Rotterdam, Netherlands

  • HAGA

    The Hague, Netherlands

  • Haaglanden Medisch Centrum

    The Hague, Netherlands

  • Heinrich-Heine University Hospital Dusseldorf

    Düsseldorf, Germany

  • Leiden UMC

    Leiden, Netherlands

  • Maastricht UMC

    Maastricht, Netherlands

  • Martini Hospital

    Groningen, Netherlands

  • Medical Center Leeuwarden

    Leeuwarden, Netherlands

  • Noordwest ziekenhuizengroep Alkmaar

    Alkmaar, Netherlands

  • Onze Lieve Vrouwen Gasthuis

    Amsterdam, Netherlands

  • Ospedale Policlinico San Martino

    Genoa, Italy

  • Radboud UMC

    Nijmegen, Netherlands

  • Rijnstate Hospital

    Arnhem, Netherlands

  • Spaarne Gasthuis Hospital

    Haarlem, Netherlands

  • UMC Groningen

    Groningen, Netherlands

  • University hospital Carl Gustav Carus

    Dresden, Germany

  • University hospital Napoli

    Naples, Italy

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