Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06452784
Status:
RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-06-05
Brief Title:
Pre- and Postoperative Apnea-Hypopnea Index After Same-Day Discharge Bariatric Surgery
Sponsor:
Rijnstate Hospital
Organization:
Rijnstate Hospital
Study Overview
Official Title:
Assessment of Pre- and Postoperative Apnea-Hypopnea Index After Same-Day Discharge Bariatric Surgery in Patients With Potentially Undiagnosed Obstructive Sleep Apnea
Status:
RECRUITING
Status Verified Date:
2024-06
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:
DAGBAR
Brief Summary:
A recent development is same-day discharge in bariatric surgery this seems to be safe if proper discharge criteria are used However yet there is no guideline for these discharge criteria including for patients with potential Obstructive Sleep Apnea OSA To establish proper discharge criteria concerning OSA more information about changes in OSA during the first days after bariatric surgery is required
The aim of this study is to assess postoperative Apnea-Hypopnea Index AHI changes during the first and third night after Same-Day Discharge bariatric surgery in patients with potentially untreated OSA
Methods Patients n60 will undergo a Home Sleep Apnea test pre-operatively and during the first en third postoperative night after bariatric surgery to asses the AHI and sleep architecture
The aim of this study is to assess postoperative Apnea-Hypopnea Index AHI changes during the first and third night after Same-Day Discharge bariatric surgery in patients with potentially untreated OSA
Methods Patients n60 will undergo a Home Sleep Apnea test pre-operatively and during the first en third postoperative night after bariatric surgery to asses the AHI and sleep architecture
Detailed Description:
Rationale
Bariatric surgery is a highly effective and sustainable treatment against obesity Recently there has been a trend towards Same-Day Discharge SDD bariatric surgery SDD bariatric surgery has proven to be safe when proper discharge criteria are used However there is no consensus or guideline for discharge criteria for SDD bariatric surgery In particular discharge criteria for patients with obstructive sleep apnea OSA diverge between hospitals In some but not all hospitals having untreated OSA is a contra-indication for SDD bariatric surgery
In Rijnstate hospital bariatric patients are not routinely tested for OSA preoperatively meaning that they potentially have undiagnosed OSA Having potentially undiagnosed OSA is not a contra-indication for SDD bariatric surgery in Rijnstate hospital Hospitals could be hesitant for SDD bariatric surgery in patients with OSA because it is known that the apnea hypopnea index AHI increases postoperatively In a population without obesity the highest postoperative AHI was found during the third postoperative night During this third postoperative night patients with a normal postoperative course will already sleep at home both after inpatient and SDD bariatric surgery This raises the question whether having untreated OSA should be a contra-indication for SDD bariatric surgery However it is unknown if the same postoperative changes in AHI and sleep architecture occur in patients undergoing bariatric surgery Objective The primary objective of this study is to assess postoperative Apnea-Hypopnea Index AHI changes during the first and third night after Same-Day Discharge bariatric surgery in patients with potentially untreated OSA The secondary objective of this study is to compare postoperative AHI changes between patients with a pre-operative AHI of 0-14 or 15 The tertiary objective of this study is to describe and compare pre- and postoperative sleep architecture
Study design
This is a prospective observational study AHI and sleep architecture will be assessed and compared before and after Same-Day discharge SDD bariatric surgery during the first and third postoperative night with Home Sleep Apnea Tests
Study population Patients scheduled for primary SDD bariatric surgery without treated OSA
Main study parametersendpoints Primary endpoint is AHI Secondary and tertiary endpoints are 30 days complications rate and parameters for sleep architecture and sleep related breathing
Bariatric surgery is a highly effective and sustainable treatment against obesity Recently there has been a trend towards Same-Day Discharge SDD bariatric surgery SDD bariatric surgery has proven to be safe when proper discharge criteria are used However there is no consensus or guideline for discharge criteria for SDD bariatric surgery In particular discharge criteria for patients with obstructive sleep apnea OSA diverge between hospitals In some but not all hospitals having untreated OSA is a contra-indication for SDD bariatric surgery
In Rijnstate hospital bariatric patients are not routinely tested for OSA preoperatively meaning that they potentially have undiagnosed OSA Having potentially undiagnosed OSA is not a contra-indication for SDD bariatric surgery in Rijnstate hospital Hospitals could be hesitant for SDD bariatric surgery in patients with OSA because it is known that the apnea hypopnea index AHI increases postoperatively In a population without obesity the highest postoperative AHI was found during the third postoperative night During this third postoperative night patients with a normal postoperative course will already sleep at home both after inpatient and SDD bariatric surgery This raises the question whether having untreated OSA should be a contra-indication for SDD bariatric surgery However it is unknown if the same postoperative changes in AHI and sleep architecture occur in patients undergoing bariatric surgery Objective The primary objective of this study is to assess postoperative Apnea-Hypopnea Index AHI changes during the first and third night after Same-Day Discharge bariatric surgery in patients with potentially untreated OSA The secondary objective of this study is to compare postoperative AHI changes between patients with a pre-operative AHI of 0-14 or 15 The tertiary objective of this study is to describe and compare pre- and postoperative sleep architecture
Study design
This is a prospective observational study AHI and sleep architecture will be assessed and compared before and after Same-Day discharge SDD bariatric surgery during the first and third postoperative night with Home Sleep Apnea Tests
Study population Patients scheduled for primary SDD bariatric surgery without treated OSA
Main study parametersendpoints Primary endpoint is AHI Secondary and tertiary endpoints are 30 days complications rate and parameters for sleep architecture and sleep related breathing
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