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Mechanical Ventilation in Surgical Patients

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06296277
Acronym
MEET VENUS
Enrollment
10000
Registered
2024-03-06
Start date
2026-03-01
Completion date
2027-08-31
Last updated
2026-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Complications, Surgery, Ventilator Lung

Brief summary

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

Detailed description

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.

Interventions

OTHERIntraoperative mechanical ventilation for surgery

Any IMV during general anesthesia for surgery

Sponsors

Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Lead SponsorOTHER
University Of Perugia
CollaboratorOTHER
University of Chieti
CollaboratorOTHER
Medical University of Vienna
CollaboratorOTHER
The Netherlands Cancer Institute
CollaboratorOTHER
Monash University
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative pulmonary complications (PPCs)within 5 days after surgeryIncidence and type of PPCs

Secondary

MeasureTime frameDescription
Intraoperative adverse events (IAEs)IntraoperativelyIncidence and type of IAEs
Intraoperative mechanical ventilation practiceIntraoperativelyMechanical ventilation settings in patients undergoing general anesthesia for surgery
Postoperative clinical outcomePostoperatively, on day 28 following surgeryHospital mortality

Countries

Italy

Contacts

CONTACTGianmaria Cammarota, Prof
gianmaria.cammarota@uniupo.it+393213733406
CONTACTRachele Simonte, MD
rachele.simonte@gmail.com
PRINCIPAL_INVESTIGATORGianmaria Cammarota, Prof

Università degli Studi del Piemonte Orientale

STUDY_DIRECTORRachele Simonte, MD

University Of Perugia

STUDY_DIRECTOREdoardo M De Robertis, Prof

University Of Perugia

STUDY_DIRECTORSabrine N.T. Hemmes, MD

Department of Anesthesiology The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands

STUDY_DIRECTORMarcus J Schultz, Prof

Department of Anaesthesia, General Intensive Care & Pain Management, Medical University of Vienna

STUDY_CHAIRSalvatore M Maggiore, Prof

Department of Anesthesiology and Intensive Care, Ospedale SS Annunziata & Department of Innovative Technologies in Medicine and Odonto-stomatology, Università Gabriele D'Annunzio di Chieti-Pescara, Chieti, Italy

STUDY_DIRECTORAry Serpa Neto, Prof

Australian and New Zealand Intensive Care Research Centre (ANZIC-RC), School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 29, 2026