Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06296277 |
| Other study ID # |
UPO#1! |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2024 |
| Est. completion date |
March 31, 2025 |
Study information
| Verified date |
March 2024 |
| Source |
Azienda Ospedaliero Universitaria Maggiore della Carita |
| Contact |
Gianmaria Cammarota, Prof |
| Phone |
+393213733406 |
| Email |
gianmaria.cammarota[@]uniupo.it |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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
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.
