Clinical trial NCT06452784: Pre- and Postoperative Apnea-Hypopnea Index After Same-Day Discharge Bariatric Surgery
Official title: Assessment of Pre- and Postoperative Apnea-Hypopnea Index After Same-Day Discharge Bariatric Surgery in Patients With Potentially Undiagnosed Obstructive Sleep Apnea
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obstructive Sleep Apnea
Bariatric Surgery Candidate
Same-day Discharge
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
First posted: 2024-06-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing primary same-day discharge bariatric surgery, with exclusion of patients with treated OSA, patients using alpha blockers or professional drivers

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 (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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Apnea hypopnea index (AHI)
timeFrame: Measurements will take place 7 days before and 1 and 3 days after surgery
Secondary outcomes:
measure: Oxygen Desaturation Index (ODI)
timeFrame: Measurements will take place 7 days before and 1 and 3 days after surgery
measure: The AHI during rapid eye movement (sleep)
timeFrame: Measurements will take place 7 days before and 1 and 3 days after surgery
measure: Respiratory disturbance index (RDI),
timeFrame: Measurements will take place 7 days before and 1 and 3 days after surgery
measure: Percentage of time with a saturation <90%
timeFrame: Measurements will take place 7 days before and 1 and 3 days after surgery
measure: Time of a saturation <90%
timeFrame: Measurements will take place 7 days before and 1 and 3 days after surgery
measure: Mean saturation
timeFrame: Measurements will take place 7 days before and 1 and 3 days after surgery
measure: Mean saturation during desaturations
timeFrame: Measurements will take place 7 days before and 1 and 3 days after surgery
measure: Number of desaturations
timeFrame: 10 days
measure: Total sleep time (minutes)
timeFrame: Measurements will take place 7 days before and 1 and 3 days after surgery
measure: Percentage of total sleep in REM sleep
timeFrame: Measurements will take place 7 days before and 1 and 3 days after surgery
measure: Time in REM sleep (minutes)
timeFrame: Measurements will take place 7 days before and 1 and 3 days after surgery
measure: Percentage of total sleep in deep sleep
timeFrame: Measurements will take place 7 days before and 1 and 3 days after surgery
measure: The time in deep sleep (minutes)
timeFrame: Measurements will take place 7 days before and 1 and 3 days after surgery
measure: Percentage of total sleep in light sleep
timeFrame: Measurements will take place 7 days before and 1 and 3 days after surgery
measure: The time in light sleep (minutes)
timeFrame: Measurements will take place 7 days before and 1 and 3 days after surgery
measure: Percentage of awake time
timeFrame: Measurements will take place 7 days before and 1 and 3 days after surgery
measure: The awake time (minutes)
timeFrame: Measurements will take place 7 days before and 1 and 3 days after surgery
Other outcomes:
Locations:
city: Elst
country: Netherlands
facility: Vitalys
Study officials:
affiliation: Vitalys part of Rijnstate
name: Eric Hazebroek, Professor
role: PRINCIPAL_INVESTIGATOR
References: