Pre- and Postoperative Apnea-Hypopnea Index After Same-Day Discharge Bariatric Surgery

Obstructive Sleep Apnea Clinical Trial

— DAGBAR  

Official title:

Assessment of Pre- and Postoperative Apnea-Hypopnea Index After Same-Day Discharge Bariatric Surgery in Patients With Potentially Undiagnosed Obstructive Sleep Apnea

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06452784
• Other study ID #: 2024-2418
• Status: Recruiting
• Start date: May 31, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: June 2024
• Source: Rijnstate Hospital
• Contact: Claudia Berends, Msc
• Phone: +31880055970
• Email: clberends[@]rijnstate.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 (n=60) 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.

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 parameters/endpoints: Primary endpoint is AHI. Secondary and tertiary endpoints are 30 days complications rate, and parameters for sleep architecture and sleep related breathing.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 30, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Undergo primary bariatric surgery (Roux and y gastric bypass or sleeve gastrectomy)

• Eligible for same-day discharge

• In possession and able to use a smartphone

Exclusion Criteria:

• Revisional bariatric surgery (e.g. sleeve conversion, RYGB after gastric banding)

• Not eligible for same-day discharge

• Diagnosed OSA with treatment (CPAP, oral appliances)

• Professional drivers

• Use of alpha blockers

• Unable to speak or read the Dutch language

• Not in possession or not able to use a smartphone

Related Conditions & MeSH terms

• Apnea
• Bariatric Surgery Candidate
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
Netherlands	Vitalys	Elst

Sponsors (1)

Lead Sponsor	Collaborator
Rijnstate Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea hypopnea index (AHI)	The AHI will be measured by the Watchpat One and compared between the different timepoints.	Measurements will take place 7 days before and 1 and 3 days after surgery
Secondary	Oxygen Desaturation Index (ODI)	The ODI will be measured by the Watchpat One and compared between the different timepoints.	Measurements will take place 7 days before and 1 and 3 days after surgery
Secondary	The AHI during rapid eye movement (sleep)	The AHI during REM sleep will be measured by the Watchpat One and compared between the different timepoints.	Measurements will take place 7 days before and 1 and 3 days after surgery
Secondary	Respiratory disturbance index (RDI),	The RDI will be measured by the Watchpat One and compared between the different timepoints.	Measurements will take place 7 days before and 1 and 3 days after surgery
Secondary	Percentage of time with a saturation <90%	The percentage of time with a saturation <90% will be measured by the Watchpat One and compared between the different timepoints.	Measurements will take place 7 days before and 1 and 3 days after surgery
Secondary	Time of a saturation <90%	Time of a saturation <90% will be measured by the Watchpat One and compared between the different timepoints.	Measurements will take place 7 days before and 1 and 3 days after surgery
Secondary	Mean saturation	Mean saturation will be measured by the Watchpat One and compared between the different timepoints.	Measurements will take place 7 days before and 1 and 3 days after surgery
Secondary	Mean saturation during desaturations	Mean desaturation during desaturations will be measured by the Watchpat One and compared between the different timepoints.	Measurements will take place 7 days before and 1 and 3 days after surgery
Secondary	Number of desaturations	The number of desaturations will be measured by the Watchpat One and compared between the different timepoints.	10 days
Secondary	Total sleep time (minutes)	The total sleep time will be measured by the Watchpat One and compared between the different timepoints.	Measurements will take place 7 days before and 1 and 3 days after surgery
Secondary	Percentage of total sleep in REM sleep	The percentage of REM sleep will be measured by the Watchpat One and compared between the different timepoints.	Measurements will take place 7 days before and 1 and 3 days after surgery
Secondary	Time in REM sleep (minutes)	The time in REM sleep will be measured by the Watchpat One and compared between the different timepoints.	Measurements will take place 7 days before and 1 and 3 days after surgery
Secondary	Percentage of total sleep in deep sleep	The percentage of deep sleep will be measured by the Watchpat One and compared between the different timepoints.	Measurements will take place 7 days before and 1 and 3 days after surgery
Secondary	The time in deep sleep (minutes)	The time in deep sleep will be measured by the Watchpat One and compared between the different timepoints.	Measurements will take place 7 days before and 1 and 3 days after surgery
Secondary	Percentage of total sleep in light sleep	The percentage of light sleep will be measured by the Watchpat One and compared between the different timepoints.	Measurements will take place 7 days before and 1 and 3 days after surgery
Secondary	The time in light sleep (minutes)	The time in light sleep will be measured by the Watchpat One and compared between the different timepoints.	Measurements will take place 7 days before and 1 and 3 days after surgery
Secondary	Percentage of awake time	The percentage of awake time will be measured by the Watchpat One and compared between the different timepoints.	Measurements will take place 7 days before and 1 and 3 days after surgery
Secondary	The awake time (minutes)	The awake time will be measured by the Watchpat One and compared between the different timepoints.	Measurements will take place 7 days before and 1 and 3 days after surgery