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NCT Number: NCT06296277

Mechanical Ventilation in Surgical Patients

This is an investigator-initiated, international, multicenter, prospective, cross-sectional study that aims to 1) describe the incidence and types of postoperative pulmonary complications (PPCs), 2) describe patient demographics, baseline characteristics, and intraoperative ventilation management, 3) describe the occurrence of intraoperative adverse events (IAEs), and 4) their associations with PPCs, 5) assess the practice of intraoperative mechanical ventilation.

Patients will be eligible for participation if: 1) adult and 2) receiving intraoperative ventilation during general anesthesia for surgery. Patients receiving ventilation outside of an operating room as well as patients receiving intraoperative ventilation during extracorporeal life support will be excluded

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Ospedaliero Universitaria di Alessandria

Alessandria, Italy

Location status: Recruiting

Location contact

Gianmaria Cammarota, Associate Professor

CONTACT

[email protected]

+390131206252

About this study

This is an investigator-initiated, international, multicenter, prospective, cross-sectional study The here proposed study aims to 1) describe the incidence and types of postoperative pulmonary complications (PPCs), 2) describe patient demographics, baseline characteristics, and intraoperative ventilation management, 3) describe the occurrence of intraoperative adverse events (IAEs), and 4) their associations with PPCs, 5) assess the practice of intraoperative mechanical ventilation.

Patients will be eligible for participation if: 1) adult and 2) receiving intraoperative ventilation during general anesthesia for surgery. Patients receiving ventilation outside of an operating room as well as patients receiving intraoperative ventilation during extracorporeal life support will be excluded.

The primary endpoint is to report the number of patients with PPCs occurring in the first 5 postoperative days. As secondary endpoint, the practice of mechanical ventilation in patients undergoing general anesthesia for surgery will be ascertained including key intraoperative ventilator characteristics and respiratory system mechanics. Other secondary endpoints will include: incidence and type of IAEs; postoperative complications other than PPCs in the first 5 postoperative days; intensive care unit (ICU) admission and length of stay, hospital length of stay, and hospital mortality on day 28.

Participating hospitals have the flexibility to choose a specific time period for data collection, but it is imperative that this process occurs within 8 weeks from receiving approval by the local Ethics Committee. Furthermore, each participating center will conduct data collection during a predetermined 7-day period. Local investigators will capture data in an electronic case recording form, including patient demographics and baseline characteristics, intraoperative ventilator settings and ventilation parameters, and outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults; and
  • Receiving intraoperative IMV (via tracheal intubation, or supraglottic device ) during general anesthesia for surgery

Exclusion criteria

  • Receiving intraoperative IMV outside of an operating room; and
  • Receiving intraoperative IMV during extracorporeal life support

Treatment and study plan

Intraoperative mechanical ventilation for surgery

Other

Any IMV during general anesthesia for surgery

Primary outcomes

  1. Postoperative pulmonary complications (PPCs)

    Time frame: within 5 days after surgery

    Incidence and type of PPCs

Secondary outcomes

  1. Intraoperative adverse events (IAEs)

    Time frame: Intraoperatively

    Incidence and type of IAEs

  2. Intraoperative mechanical ventilation practice

    Time frame: Intraoperatively

    Mechanical ventilation settings in patients undergoing general anesthesia for surgery

  3. Postoperative clinical outcome

    Time frame: Postoperatively, on day 28 following surgery

    Hospital mortality

Study contacts

Contact information is provided by the study sponsor or research team.

Gianmaria Cammarota, Prof

CONTACT

[email protected]

+393213733406

Rachele Simonte, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

Other

Collaborators

  • Medical University of Vienna
  • Monash University
  • The Netherlands Cancer Institute
  • University Of Perugia
  • University of Chieti

Registry information

Official study title

Management of Mechanical Ventilation During Surgery: an International, Multicenter, and Observational Data Registry

Acronym: MEET VENUS

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 6, 2024
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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