Ignite Creation Date:
2024-05-06 @ 9:59 AM
Last Modification Date:
2024-10-26 @ 12:23 PM
Study NCT ID:
NCT03135691
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-16
First Post:
2017-01-30
Brief Title:
Intraop Ventilation Management and Postop Pulmonary Complications in High Risk Patients for OSA
Sponsor:
Ohio State University
Organization:
Ohio State University
Study Overview
Official Title:
Intraoperative Ventilation Management and Postoperative Pulmonary Complications in Patients at High Risk for Obstructive Sleep Apnea
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
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:
None
Brief Summary:
Lung protective ventilation LPV has been proposed to reduce the incidence of postoperative pulmonary complications PPCs and protect against ventilator induced lung injury VILI
Detailed Description:
LPV was first introduced in the intensive care units but has been recently adopted in the operating rooms Obstructive sleep apnea OSA is a widely prevalent condition in obese patients and requires special attention in the operating room Screening for OSA risk in surgical patients is a common practice The STOP-BANG questionnaire is a common screening tool for OSA Snoring Tiredness Observed apnea high blood Pressure BMI Age Neck circumference and male Gender The American Society of Anesthesiologists practice guidelines for the perioperative management of patients with OSA do not recommend any specific ventilation strategy to prevent PPCs in this population To the knowledge of the investigators the association between intraoperative ventilation strategies and PPCs in laparoscopic bariatric surgery patients who have a high STOP-BANG score has not been adequately investigated The investigators propose a retrospective chart review of patients 18 years of age and older who underwent laparoscopic bariatric surgery in reverse Trendelenburg position using pressure controlled ventilation PCVPCV-VG at the Ohio State University Wexner Medical Center between January 01 2012 and November 22 2016 to determine whether intraoperative driving pressure is a predictor of postoperative pulmonary complications No procedures will be done for the sake of conducting this study except for a retrospective review of patient charts Preoperative and intraoperative variables will be collected to determine their predictive value of postoperative complications No risks to the patients health or well being are anticipated due to the conduct of the proposed study No immediate benefits to the patients from whom data was collected is anticipated either Results obtained from this study may provide valuable information on the preferred ventilation strategies in the operating room for future patients who have a high risk of postoperative lung complications
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