Comparison of Apnea-Hypopnea Index in Patients With or Without Preventive Oxygen Therapy After Bariatric Surgery
NCT06432933 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 153
Last updated 2025-07-18
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
Interventions
- OTHER
-
No preventive oxygen therapy (2L)
Participants will not receive preventive oxygen 2L during the first postoperative night after bariatric surgery.
- OTHER
-
Preventive oxygen therapy (2L) standard care
Participants will receive preventive oxygen 2L during the first postoperative night after bariatric surgery, standard care.
Sponsors & Collaborators
-
Rijnstate Hospital
lead OTHER
Principal Investigators
-
Eric Hazebroek, Prof.dr. · Rijnstate Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-04-09
- Primary Completion
- 2025-03-21
- Completion
- 2025-03-21
Countries
- Netherlands
Study Locations
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