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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All study participants | Alle study participants will receive standard of care. For this study participants will complete two short questionnaires (the STOPBANG and ESS) and will undergo three home sleep apnea tests with the WatchPat one. These will be performed during the night seven days prior to surgery and during night one and three after surgery. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| The AHI during rapid eye movement (sleep) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing primary same-day discharge bariatric surgery, with exclusion of patients with treated OSA, patients using alpha blockers or professional drivers
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| Name | Affiliation | Role |
|---|---|---|
| Eric Hazebroek, Professor | Vitalys part of Rijnstate | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vitalys | Elst | 6662 NC | Netherlands |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Number of desaturations | The number of desaturations will be measured by the Watchpat One and compared between the different timepoints. | 10 days |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |