Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06296277
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-18
First Post:
2024-02-29
Brief Title:
Mechanical Ventilation in Surgical Patients
Sponsor:
Azienda Ospedaliero Universitaria Maggiore della Carita
Organization:
Azienda Ospedaliero Universitaria Maggiore della Carita
Study Overview
Official Title:
Management of Mechanical Ventilation During Surgery an International Multicenter and Observational Data Registry
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MEET VENUS
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None