Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06432933
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-04-03
Brief Title:
Comparison of Apnea-Hypopnea Index in Patients With or Without Preventive Oxygen Therapy After Bariatric Surgery
Sponsor:
Rijnstate Hospital
Organization:
Rijnstate Hospital
Study Overview
Official Title:
Comparison of Apnea-Hypopnea Index in Patients With Potentially Undiagnosed Obstructive Sleep Apnea Treated With or Without Preventive Oxygen Therapy During the First Night After Bariatric Surgery
Status:
RECRUITING
Status Verified Date:
2024-05
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:
OXYBAR
Brief Summary:
The best perioperative strategy for obstructive sleep apnea OSA in bariatric surgery remains unclear A strategy is to monitor patients and administer preventive oxygen therapy during the first postoperative night However it is unknown what if preventive oxygen therapy is necessary
The goal of this trial is to compare the Apnea-Hypopnea Index AHI in participants with or without preventive oxygen therapy
Methods
Participants are patients who underwent bariatric surgery without treated OSA and will be will be randomized into arm A or arm B
Arm A First postoperative night in the hospital with preventive oxygen therapy standard care Arm B First postoperative night in hospital without preventive oxygen therapy intervention
The goal of this trial is to compare the Apnea-Hypopnea Index AHI in participants with or without preventive oxygen therapy
Methods
Participants are patients who underwent bariatric surgery without treated OSA and will be will be randomized into arm A or arm B
Arm A First postoperative night in the hospital with preventive oxygen therapy standard care Arm B First postoperative night in hospital without preventive oxygen therapy intervention
Detailed Description:
Rationale The prevalence of obstructive sleep apnea OSA in the bariatric surgery population is high and mostly undiagnosed The best perioperative strategy to manage sleep apnea in bariatric patients remains unclear A recent study found that monitoring patients with pulsoximetry and giving them preventive oxygen therapy during the first postoperative night is safe and cost effective In a population with patients with OSA but without obesity no significant difference in apnea hypopnea index AHI was found between patients with and without oxygen therapy during the first postoperative night The question was raised if preventive oxygen therapy during the first postoperative night after bariatric surgery is needed
Objective The primary objective of this study is to compare AHI in patients with potentially undiagnosed OSA treated with or without preventive oxygen therapy during the first night after bariatric surgery The secondary objective of this study is to compare sleep architecture in these patients
Study design This is a randomized controlled non-inferiority trial consisting of two arms Arm A First postoperative night in the hospital with preventive oxygen therapy standard care Arm B First postoperative night in hospital without preventive oxygen therapy intervention
Study population Patients scheduled for primary bariatric surgery without treated OSA Intervention During the first postoperative night at the hospital patients in intervention arm B will not receive preventive oxygen therapy
Main study parametersendpoints Primary endpoint is AHI and secondary endpoints are 30 days complications rate nursing intervention rate and parameters for sleep architecture and sleep related breathing score of the Epworth Sleepiness Scale ESS and STOP BANG
Objective The primary objective of this study is to compare AHI in patients with potentially undiagnosed OSA treated with or without preventive oxygen therapy during the first night after bariatric surgery The secondary objective of this study is to compare sleep architecture in these patients
Study design This is a randomized controlled non-inferiority trial consisting of two arms Arm A First postoperative night in the hospital with preventive oxygen therapy standard care Arm B First postoperative night in hospital without preventive oxygen therapy intervention
Study population Patients scheduled for primary bariatric surgery without treated OSA Intervention During the first postoperative night at the hospital patients in intervention arm B will not receive preventive oxygen therapy
Main study parametersendpoints Primary endpoint is AHI and secondary endpoints are 30 days complications rate nursing intervention rate and parameters for sleep architecture and sleep related breathing score of the Epworth Sleepiness Scale ESS and STOP BANG
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