Clinical trial NCT06432933: Comparison of Apnea-Hypopnea Index in Patients With or Without Preventive Oxygen Therapy After Bariatric Surgery
Official title: Comparison of Apnea-Hypopnea Index, in Patients With Potentially Undiagnosed Obstructive Sleep Apnea, Treated With or Without Preventive Oxygen Therapy, During the First Night After Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea
Obesity
Bariatric Surgery Candidate
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
First posted: 2024-05-29
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Undergo primary bariatric surgery (RYGB or SG)
* Speak and read the Dutch language

Exclusion Criteria:

* 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

Primary outcomes:
measure: Apnea-Hypopnea Index (AHI)
timeFrame: First postoperative night
Secondary outcomes:
measure: Complication rate
timeFrame: Until 30 days after surgery
measure: The number of nursing interventions
timeFrame: First postoperative night
measure: Type of nursing interventions
timeFrame: First postoperative night
measure: Oxygen Desaturation Index (ODI)
timeFrame: First postoperative night
measure: AHI during Rapid Eye Movement (REM) sleep
timeFrame: First postoperative night
measure: Respiratory disturbance index (RDI)
timeFrame: First postoperative night
measure: Mean saturation
timeFrame: First postoperative night
measure: Mean saturation during desaturations,
timeFrame: First postoperative night
measure: Number of desaturations
timeFrame: First postoperative night
measure: Percentage of saturation <90%
timeFrame: First postoperative night
measure: Percentage of saturation <88%
timeFrame: First postoperative night
measure: Percentage of saturation <85%
timeFrame: First postoperative night
measure: Percentage of saturation <80%
timeFrame: First postoperative night
measure: Percentage of saturation <70%
timeFrame: First postoperative night
measure: Time (minutes) of saturation <90%
timeFrame: First postoperative night
measure: Time (minutes) of saturation <88%
timeFrame: First postoperative night
measure: Time (minutes) of saturation <85%
timeFrame: First postoperative night
measure: Time (minutes) of saturation <80%
timeFrame: First postoperative night
measure: Time (minutes) of saturation <70%
timeFrame: First postoperative night
measure: Total sleep time (minutes)
timeFrame: First postoperative night
measure: Percentage of REM sleep in total sleep time
timeFrame: First postoperative night
measure: Percentage of Deep sleep in total sleep time
timeFrame: First postoperative night
measure: Percentage of light sleep in total sleep time
timeFrame: First postoperative night
measure: Percentage of awake time
timeFrame: First postoperative night
Other outcomes:
Locations:
city: Elst
country: Netherlands
facility: Vitalys
Study officials:
affiliation: Rijnstate Hospital
name: Eric Hazebroek, Prof.dr.
role: PRINCIPAL_INVESTIGATOR
References: