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

NCT ID: NCT06432933

Last Updated: 2025-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 153 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-09
• Study Completion Date: 2025-03-21

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.

Conditions

Obstructive Sleep Apnea; Obesity; Bariatric Surgery Candidate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Without preventive oxygen therapy

Group Type: EXPERIMENTAL

No preventive oxygen therapy (2L)

Intervention Type: OTHER

Participants will not receive preventive oxygen 2L during the first postoperative night after bariatric surgery.

With preventive oxygentherapy

Group Type: ACTIVE_COMPARATOR

Preventive oxygen therapy (2L) standard care

Intervention Type: OTHER

Participants will receive preventive oxygen 2L during the first postoperative night after bariatric surgery, standard care.

Interventions

No preventive oxygen therapy (2L)

Participants will not receive preventive oxygen 2L during the first postoperative night after bariatric surgery.

Intervention Type: OTHER

Preventive oxygen therapy (2L) standard care

Participants will receive preventive oxygen 2L during the first postoperative night after bariatric surgery, standard care.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rijnstate Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric Hazebroek, Prof.dr.

Role: PRINCIPAL_INVESTIGATOR

Rijnstate Hospital

Locations

Vitalys

Elst, , Netherlands

Countries

Netherlands

Other Identifiers

2023-2352

Identifier Type: -

Identifier Source: org_study_id