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The best perioperative strategy for obstructive sleep apnea (OSA) in bariatric surgery remains unclear. A strategy is to monitor patients and administer preventive oxygen therapy during the first postoperative night. However it is unknown what if preventive oxygen therapy is necessary.
The goal of this trial is to compare the Apnea-Hypopnea Index (AHI) in participants with or without preventive oxygen therapy.
Methods:
Participants are patients who underwent bariatric surgery without treated OSA and will be will be randomized into arm A or arm B:
Arm A: First postoperative night in the hospital with preventive oxygen therapy (standard care), Arm B: First postoperative night in hospital without preventive oxygen therapy (intervention).
Rationale: The prevalence of obstructive sleep apnea (OSA) in the bariatric surgery population is high and mostly undiagnosed. The best perioperative strategy to manage sleep apnea in bariatric patients remains unclear. A recent study found that monitoring patients with pulsoximetry and giving them preventive oxygen therapy during the first postoperative night is safe and cost effective. In a population with patients with OSA but without obesity, no significant difference in apnea hypopnea index (AHI) was found between patients with and without oxygen therapy during the first postoperative night. The question was raised if preventive oxygen therapy during the first postoperative night after bariatric surgery is needed.
Objective: The primary objective of this study is to compare AHI in patients with potentially undiagnosed OSA, treated with or without preventive oxygen therapy, during the first night after bariatric surgery. The secondary objective of this study is to compare sleep architecture in these patients
Study design: This is a randomized controlled non-inferiority trial consisting of two arms; Arm A: First postoperative night in the hospital with preventive oxygen therapy (standard care), Arm B: First postoperative night in hospital without preventive oxygen therapy (intervention).
Study population: Patients scheduled for primary bariatric surgery without treated OSA Intervention: During the first postoperative night at the hospital patients in intervention arm B will not receive preventive oxygen therapy.
Main study parameters/endpoints: Primary endpoint is AHI and secondary endpoints are 30 days complications rate, nursing intervention rate and parameters for sleep architecture and sleep related breathing, score of the Epworth Sleepiness Scale (ESS) and STOP BANG.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Without preventive oxygen therapy | Experimental |
| |
| With preventive oxygentherapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No preventive oxygen therapy (2L) | Other | Participants will not receive preventive oxygen 2L during the first postoperative night after bariatric surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Apnea-Hypopnea Index (AHI) | AHI will be measured by a home sleep study device (Watchpat300) and will be compared between both arms, the higher the AHI the more severe the sleep apnea | First postoperative night |
| Measure | Description | Time Frame |
|---|---|---|
| Complication rate | All complication will be scored and will be compared between both arms | Until 30 days after surgery |
| The number of nursing interventions | Nursing interventions will be scored on a form and the number of nursing interventions will be compared between both arms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Hazebroek, Prof.dr. | Rijnstate Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vitalys | Elst | 6662 NC | Netherlands |
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| Preventive oxygen therapy (2L) standard care | Other | Participants will receive preventive oxygen 2L during the first postoperative night after bariatric surgery, standard care. |
|
| First postoperative night |
| Type of nursing interventions | e.g. waking up the patient or starting or increasing oxygen therapy/flow, this will be compared between both arms. | First postoperative night |
| Oxygen Desaturation Index (ODI) | ODI will be measured by a home sleep study device (Watchpat300) and will be compared between both arms | First postoperative night |
| AHI during Rapid Eye Movement (REM) sleep | AHI during REM sleep will be measured by a home sleep study device (Watchpat300) and will be compared between both arms | First postoperative night |
| Respiratory disturbance index (RDI) | RDI will be measured by a home sleep study device (Watchpat300) and will be compared between both arms | First postoperative night |
| Mean saturation | Mean saturation will be measured by a home sleep study device (Watchpat300) and will be compared between both arms | First postoperative night |
| Mean saturation during desaturations, | Mean saturation during desaturations will be measured by a home sleep study device (Watchpat300) and will be compared between both arms | First postoperative night |
| Number of desaturations | Number of desaturations will be measured by a home sleep study device (Watchpat300) and will be compared between both arms | First postoperative night |
| Percentage of saturation <90% | will be measured by a home sleep study device (Watchpat300) and will be compared between both arms | First postoperative night |
| Percentage of saturation <88% | will be measured by a home sleep study device (Watchpat300) and will be compared between both arms | First postoperative night |
| Percentage of saturation <85% | will be measured by a home sleep study device (Watchpat300) and will be compared between both arms | First postoperative night |
| Percentage of saturation <80% | will be measured by a home sleep study device (Watchpat300) and will be compared between both arms | First postoperative night |
| Percentage of saturation <70% | will be measured by a home sleep study device (Watchpat300) and will be compared between both arms | First postoperative night |
| Time (minutes) of saturation <90% | will be measured by a home sleep study device (Watchpat300) and will be compared between both arms | First postoperative night |
| Time (minutes) of saturation <88% | will be measured by a home sleep study device (Watchpat300) and will be compared between both arms | First postoperative night |
| Time (minutes) of saturation <85% | will be measured by a home sleep study device (Watchpat300) and will be compared between both arms | First postoperative night |
| Time (minutes) of saturation <80% | will be measured by a home sleep study device (Watchpat300) and will be compared between both arms | First postoperative night |
| Time (minutes) of saturation <70% | will be measured by a home sleep study device (Watchpat300) and will be compared between both arms | First postoperative night |
| Total sleep time (minutes) | Total sleep time will be measured by a home sleep study device (Watchpat300) and will be compared between both arms | First postoperative night |
| Percentage of REM sleep in total sleep time | Percentage of REM sleep will be measured by a home sleep study device (Watchpat300) and will be compared between both arms | First postoperative night |
| Percentage of Deep sleep in total sleep time | Percentage of Deep sleep will be measured by a home sleep study device (Watchpat300) and will be compared between both arms | First postoperative night |
| Percentage of light sleep in total sleep time | Percentage of light sleep will be measured by a home sleep study device (Watchpat300) and will be compared between both arms | First postoperative night |
| Percentage of awake time | Percentage of awake time will be measured by a home sleep study device (Watchpat300) and will be compared between both arms | First postoperative night |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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