Vitalys
Elst, 6662 NC, Netherlands
NCT Number: NCT06452784
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.
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Notify Me18 year and older
All sexes
Observational
Elst, 6662 NC, Netherlands
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Measurements will take place 7 days before and 1 and 3 days after surgery
The AHI will be measured by the Watchpat One and compared between the different timepoints.
Time frame: Measurements will take place 7 days before and 1 and 3 days after surgery
The ODI will be measured by the Watchpat One and compared between the different timepoints.
Time frame: Measurements will take place 7 days before and 1 and 3 days after surgery
The AHI during REM sleep will be measured by the Watchpat One and compared between the different timepoints.
Time frame: Measurements will take place 7 days before and 1 and 3 days after surgery
The RDI will be measured by the Watchpat One and compared between the different timepoints.
Time frame: Measurements will take place 7 days before and 1 and 3 days after surgery
The percentage of time with a saturation <90% will be measured by the Watchpat One and compared between the different timepoints.
Time frame: Measurements will take place 7 days before and 1 and 3 days after surgery
Time of a saturation <90% will be measured by the Watchpat One and compared between the different timepoints.
Time frame: Measurements will take place 7 days before and 1 and 3 days after surgery
Mean saturation will be measured by the Watchpat One and compared between the different timepoints.
Time frame: Measurements will take place 7 days before and 1 and 3 days after surgery
Mean desaturation during desaturations will be measured by the Watchpat One and compared between the different timepoints.
Time frame: 10 days
The number of desaturations will be measured by the Watchpat One and compared between the different timepoints.
Time frame: Measurements will take place 7 days before and 1 and 3 days after surgery
The total sleep time will be measured by the Watchpat One and compared between the different timepoints.
Time frame: Measurements will take place 7 days before and 1 and 3 days after surgery
The percentage of REM sleep will be measured by the Watchpat One and compared between the different timepoints.
Time frame: Measurements will take place 7 days before and 1 and 3 days after surgery
The time in REM sleep will be measured by the Watchpat One and compared between the different timepoints.
Time frame: Measurements will take place 7 days before and 1 and 3 days after surgery
The percentage of deep sleep will be measured by the Watchpat One and compared between the different timepoints.
Time frame: Measurements will take place 7 days before and 1 and 3 days after surgery
The time in deep sleep will be measured by the Watchpat One and compared between the different timepoints.
Time frame: Measurements will take place 7 days before and 1 and 3 days after surgery
The percentage of light sleep will be measured by the Watchpat One and compared between the different timepoints.
Time frame: Measurements will take place 7 days before and 1 and 3 days after surgery
The time in light sleep will be measured by the Watchpat One and compared between the different timepoints.
Time frame: Measurements will take place 7 days before and 1 and 3 days after surgery
The percentage of awake time will be measured by the Watchpat One and compared between the different timepoints.
Time frame: Measurements will take place 7 days before and 1 and 3 days after surgery
The awake time will be measured by the Watchpat One and compared between the different timepoints.
Rijnstate Hospital
Other
Assessment of Pre- and Postoperative Apnea-Hypopnea Index After Same-Day Discharge Bariatric Surgery in Patients With Potentially Undiagnosed Obstructive Sleep Apnea
Acronym: DAGBAR
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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