Mechanical Ventilation in Surgical Patients

NCT06296277 | Not Yet Recruiting

• 1 other identifier: UPO#1!
• Study Type: observational
• Target: 10,000
• Locations: 0 countries
• Sites: N/A

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

Conditions

Surgery; Ventilator Lung; Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• Postoperative pulmonary complications (PPCs)

  Incidence and type of PPCs

  within 5 days after surgery

Secondary Outcomes (3)

• Intraoperative adverse events (IAEs)

  Intraoperatively

• Intraoperative mechanical ventilation practice

  Intraoperatively

• Postoperative clinical outcome

  Postoperatively, on day 28 following surgery

Study Arms (1)

Intraoperative mechanical ventilation

Patients subjected to invasive mechanical ventilation (IMV) during general anesthesia for surgery

Other: Intraoperative mechanical ventilation for surgery

Interventions

Intraoperative mechanical ventilation for surgery OTHER

Any IMV during general anesthesia for surgery

Intraoperative mechanical ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria: lead
• University Of Perugia: collaborator
• University of Chieti: collaborator
• Medical University of Vienna: collaborator
• The Netherlands Cancer Institute: collaborator
• Monash University: collaborator

MeSH Terms

Conditions

Postoperative Complications

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gianmaria Cammarota, Prof

  Università degli Studi del Piemonte Orientale

  PRINCIPAL INVESTIGATOR

• 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 DIRECTOR

• 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 CHAIR

• 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 DIRECTOR

Central Study Contacts

Gianmaria Cammarota, Prof

CONTACT

+393213733406; gianmaria.cammarota@uniupo.it

Rachele Simonte, MD

CONTACT

rachele.simonte@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Gianmaria Cammarota

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 6, 2024
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: June 6, 2025

Record last verified: 2025-06