An observational study in Surgery, Ventilator Lung and Postoperative Complications, sponsored by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-28.
Sponsored by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria · Observational
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
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.
1,332 studies on the registry are indexed under Postoperative Complications; 311 are open to participants now.
This study's planned enrollment of 10,000 is above the median of 251 across 537 observational studies indexed under Postoperative Complications.
Browse Postoperative Complications studies →Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria is the lead sponsor of 37 studies on the registry; 13 are open to participants now.
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Patients subjected to IMV during general anesthesia for surgery will be included in a consecutive manner
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Exclusion Criteria:
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
Postoperative pulmonary complications (PPCs)
Incidence and type of PPCs
Time frame: within 5 days after surgery
Intraoperative adverse events (IAEs)
Incidence and type of IAEs
Time frame: Intraoperatively
Intraoperative mechanical ventilation practice
Mechanical ventilation settings in patients undergoing general anesthesia for surgery
Time frame: Intraoperatively
Postoperative clinical outcome
Hospital mortality
Time frame: Postoperatively, on day 28 following surgery
Plan to share: Undecided
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Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria