Clinical trial NCT06296277: Mechanical Ventilation in Surgical Patients
Official title: Management of Mechanical Ventilation During Surgery: an International, Multicenter, and Observational Data Registry
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Surgery
Ventilator Lung
Postoperative Complications
Lead sponsor: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Sponsor class: OTHER
Collaborators: name: University Of Perugia
name: University of Chieti
name: Medical University of Vienna
name: The Netherlands Cancer Institute
name: Monash University
First posted: 2024-03-06
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients subjected to IMV during general anesthesia for surgery will be included in a consecutive manner

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative pulmonary complications (PPCs)
timeFrame: within 5 days after surgery
Secondary outcomes:
measure: Intraoperative adverse events (IAEs)
timeFrame: Intraoperatively
measure: Intraoperative mechanical ventilation practice
timeFrame: Intraoperatively
measure: Postoperative clinical outcome
timeFrame: Postoperatively, on day 28 following surgery
Other outcomes:
Locations:
Study officials:
affiliation: Università degli Studi del Piemonte Orientale
name: Gianmaria Cammarota, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: University Of Perugia
name: Rachele Simonte, MD
role: STUDY_DIRECTOR
affiliation: University Of Perugia
name: Edoardo M De Robertis, Prof
role: STUDY_DIRECTOR
affiliation: Department of Anesthesiology The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands
name: Sabrine N.T. Hemmes, MD
role: STUDY_DIRECTOR
affiliation: Department of Anaesthesia, General Intensive Care & Pain Management, Medical University of Vienna
name: Marcus J Schultz, Prof
role: STUDY_DIRECTOR
affiliation: 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
name: Salvatore M Maggiore, Prof
role: STUDY_CHAIR
affiliation: Australian and New Zealand Intensive Care Research Centre (ANZIC-RC), School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia
name: Ary Serpa Neto, Prof
role: STUDY_DIRECTOR
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