Comparison of Apnea-Hypopnea Index in Patients With or Without Preventive Oxygen Therapy After Bariatric Surgery
- Conditions
- ObesityObstructive Sleep ApneaBariatric Surgery Candidate
- Interventions
- Other: Preventive oxygen therapy (2L) standard careOther: No preventive oxygen therapy (2L)
- Registration Number
- NCT06432933
- Lead Sponsor
- Rijnstate Hospital
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 152
- Undergo primary bariatric surgery (RYGB or SG)
- Speak and read the Dutch language
- Revisional bariatric surgery (e.g. sleeve conversion, RYGB after gastric banding)
- Same-day discharge after bariatric surgery
- Diagnosed OSA with treatment (CPAP, oral appliances)
- Professional drivers
- Use of alpha blockers
- Unable to speak or read the Dutch language
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description With preventive oxygentherapy Preventive oxygen therapy (2L) standard care - Without preventive oxygen therapy No preventive oxygen therapy (2L) -
- Primary Outcome Measures
Name Time Method Apnea-Hypopnea Index (AHI) First postoperative night 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
- Secondary Outcome Measures
Name Time Method Percentage of saturation <85% First postoperative night will be measured by a home sleep study device (Watchpat300) and will be compared between both arms
Mean saturation First postoperative night Mean saturation will be measured by a home sleep study device (Watchpat300) and will be compared between both arms
Mean saturation during desaturations, First postoperative night Mean saturation during desaturations will be measured by a home sleep study device (Watchpat300) and will be compared between both arms
Percentage of saturation <90% First postoperative night will be measured by a home sleep study device (Watchpat300) and will be compared between both arms
Percentage of saturation <80% First postoperative night will be measured by a home sleep study device (Watchpat300) and will be compared between both arms
Time (minutes) of saturation <80% First postoperative night will be measured by a home sleep study device (Watchpat300) and will be compared between both arms
Percentage of light sleep in total sleep time First postoperative night Percentage of light sleep will be measured by a home sleep study device (Watchpat300) and will be compared between both arms
The number of nursing interventions First postoperative night Nursing interventions will be scored on a form and the number of nursing interventions will be compared between both arms
Type of nursing interventions First postoperative night e.g. waking up the patient or starting or increasing oxygen therapy/flow, this will be compared between both arms.
AHI during Rapid Eye Movement (REM) sleep First postoperative night AHI during REM sleep will be measured by a home sleep study device (Watchpat300) and will be compared between both arms
Respiratory disturbance index (RDI) First postoperative night RDI will be measured by a home sleep study device (Watchpat300) and will be compared between both arms
Percentage of saturation <88% First postoperative night will be measured by a home sleep study device (Watchpat300) and will be compared between both arms
Complication rate Until 30 days after surgery All complication will be scored and will be compared between both arms
Number of desaturations First postoperative night Number of desaturations will be measured by a home sleep study device (Watchpat300) and will be compared between both arms
Time (minutes) of saturation <70% First postoperative night will be measured by a home sleep study device (Watchpat300) and will be compared between both arms
Percentage of Deep sleep in total sleep time First postoperative night Percentage of Deep sleep will be measured by a home sleep study device (Watchpat300) and will be compared between both arms
Oxygen Desaturation Index (ODI) First postoperative night ODI will be measured by a home sleep study device (Watchpat300) and will be compared between both arms
Percentage of saturation <70% First postoperative night will be measured by a home sleep study device (Watchpat300) and will be compared between both arms
Time (minutes) of saturation <85% First postoperative night will be measured by a home sleep study device (Watchpat300) and will be compared between both arms
Time (minutes) of saturation <90% First postoperative night will be measured by a home sleep study device (Watchpat300) and will be compared between both arms
Percentage of REM sleep in total sleep time First postoperative night Percentage of REM sleep will be measured by a home sleep study device (Watchpat300) and will be compared between both arms
Time (minutes) of saturation <88% First postoperative night will be measured by a home sleep study device (Watchpat300) and will be compared between both arms
Total sleep time (minutes) First postoperative night Total sleep time will be measured by a home sleep study device (Watchpat300) and will be compared between both arms
Percentage of awake time First postoperative night Percentage of awake time will be measured by a home sleep study device (Watchpat300) and will be compared between both arms
Trial Locations
- Locations (1)
Vitalys
🇳🇱Elst, Netherlands