Comparison of Apnea-Hypopnea Index in Patients With or Without Preventive Oxygen Therapy After Bariatric Surgery

Obesity Clinical Trial

— OXYBAR  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06432933
• Other study ID #: 2023-2352
• Status: Recruiting
• Phase: N/A
• Start date: April 9, 2024
• Est. completion date: July 2025

Study information

• Verified date: May 2024
• Source: Rijnstate Hospital
• Contact: Claudia Berends, Msc
• Phone: +31880055970
• Email: clberends[@]rijnstate.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Recruiting
• Enrollment: 152
• Est. completion date: July 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Bariatric Surgery Candidate
• Obesity
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Other:
• No preventive oxygen therapy (2L)
Participants will not receive preventive oxygen 2L during the first postoperative night after bariatric surgery.
• Preventive oxygen therapy (2L) standard care
Participants will receive preventive oxygen 2L during the first postoperative night after bariatric surgery, standard care.

Locations

Country	Name	City	State
Netherlands	Vitalys	Elst

Sponsors (1)

Lead Sponsor	Collaborator
Rijnstate Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Complication rate	All complication will be scored and will be compared between both arms	Until 30 days after surgery
Secondary	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	First postoperative night
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Mean saturation	Mean saturation will be measured by a home sleep study device (Watchpat300) and will be compared between both arms	First postoperative night
Secondary	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
Secondary	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
Secondary	Percentage of saturation <90%	will be measured by a home sleep study device (Watchpat300) and will be compared between both arms	First postoperative night
Secondary	Percentage of saturation <88%	will be measured by a home sleep study device (Watchpat300) and will be compared between both arms	First postoperative night
Secondary	Percentage of saturation <85%	will be measured by a home sleep study device (Watchpat300) and will be compared between both arms	First postoperative night
Secondary	Percentage of saturation <80%	will be measured by a home sleep study device (Watchpat300) and will be compared between both arms	First postoperative night
Secondary	Percentage of saturation <70%	will be measured by a home sleep study device (Watchpat300) and will be compared between both arms	First postoperative night
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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