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

R

Rijnstate Hospital

Status

Enrolling

Conditions

Bariatric Surgery Candidate
Obesity
Obstructive Sleep Apnea

Treatments

Other: No preventive oxygen therapy (2L)
Other: Preventive oxygen therapy (2L) standard care

Study type

Interventional

Funder types

Other

Identifiers

NCT06432933
2023-2352

Details and patient eligibility

About

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).

Full 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.

Enrollment

152 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

152 participants in 2 patient groups

Without preventive oxygen therapy
Experimental group
Treatment:
Other: No preventive oxygen therapy (2L)
With preventive oxygentherapy
Active Comparator group
Treatment:
Other: Preventive oxygen therapy (2L) standard care

Trial contacts and locations

1

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Central trial contact

Claudia Berends, Msc

Data sourced from clinicaltrials.gov

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