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

NCT06432933 | Completed

• 1 other identifier: 2023-2352
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

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).

Conditions

Obstructive Sleep Apnea; Obesity; Bariatric Surgery Candidate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (24)

• Complication rate

  Until 30 days after surgery

• The number of nursing interventions

  First postoperative night

• Type of nursing interventions

  First postoperative night

• Oxygen Desaturation Index (ODI)

  First postoperative night

• AHI during Rapid Eye Movement (REM) sleep

  First postoperative night

Study Arms (2)

Without preventive oxygen therapy

EXPERIMENTAL

Other: No preventive oxygen therapy (2L)

With preventive oxygentherapy

ACTIVE COMPARATOR

Other: Preventive oxygen therapy (2L) standard care

Interventions

No preventive oxygen therapy (2L) OTHER

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

Without preventive oxygen therapy

Preventive oxygen therapy (2L) standard care OTHER

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

With preventive oxygentherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rijnstate Hospital: lead

Study Sites (1)

Vitalys

Elst, 6662 NC, Netherlands

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Obesity

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Eric Hazebroek, Prof.dr.

  Rijnstate Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: May 29, 2024
• Study Start: April 9, 2024
• Primary Completion: March 21, 2025
• Study Completion: March 21, 2025
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)