Mechanical Ventilation in Surgical Patients (MEET VENUS)

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

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

Study Overview

• Status: Recruiting
• Conditions: Postoperative Complications; Surgery; Ventilator Lung
• Intervention / Treatment: Other: Intraoperative mechanical ventilation for surgery

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.

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Gianmaria Cammarota, Prof; Phone Number: +393213733406; Email: gianmaria.cammarota@uniupo.it
• Study Contact Backup: Name: Rachele Simonte, MD; Email: rachele.simonte@gmail.com

Study Locations

• Italy
  • Italy
    • Alessandria, Italy, Italy
      • Recruiting
      • Azienda Ospedaliero Universitaria di Alessandria
      • Contact: Gianmaria Cammarota, Associate Professor; Phone Number: +390131206252; Email: gianmaria.cammarota@uniupo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients subjected to IMV during general anesthesia for surgery will be included in a consecutive manner

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Intraoperative mechanical ventilation; Patients subjected to invasive mechanical ventilation (IMV) during general anesthesia for surgery	Other: Intraoperative mechanical ventilation for surgery; Any IMV during general anesthesia for surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pulmonary complications (PPCs)	Incidence and type of PPCs	within 5 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative adverse events (IAEs)	Incidence and type of IAEs	Intraoperatively
Intraoperative mechanical ventilation practice	Mechanical ventilation settings in patients undergoing general anesthesia for surgery	Intraoperatively
Postoperative clinical outcome	Hospital mortality	Postoperatively, on day 28 following surgery

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
• Collaborators: Medical University of Vienna; Monash University; University Of Perugia; The Netherlands Cancer Institute; University of Chieti
• Investigators: Principal Investigator: Gianmaria Cammarota, Prof, Università degli Studi del Piemonte Orientale; Study Director: Rachele Simonte, MD, University Of Perugia; Study Director: Edoardo M De Robertis, Prof, University Of Perugia; Study Director: Sabrine N.T. Hemmes, MD, Department of Anesthesiology The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands; Study Director: Marcus J Schultz, Prof, Department of Anaesthesia, General Intensive Care & Pain Management, Medical University of Vienna; Study Chair: Salvatore 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 Director: Ary Serpa Neto, Prof, Australian and New Zealand Intensive Care Research Centre (ANZIC-RC), School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: February 29, 2024
• First Submitted That Met QC Criteria: March 5, 2024
• First Posted (Actual): March 6, 2024

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 25, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Surgical Procedures, Operative
• Other Study ID Numbers: UPO#1!

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No