Evaluation of obstructive sleep apnea (OSA) management in obesity surgery.

Evaluation of continuous monitoring by pulse oximetry without obstructive sleep apnea (OSA) screening vs. perioperative continuous positive airway pressure (CPAP) treatment following OSA screening in patients undergoing bariatric surgery: a multicenter prospective study.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON21420

Enrollment

1380

Registered

2018-01-31

Start date

2018-03-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The population of our study consists of morbidly obese patients scheduled to undergo bariatric surgery (gastric bypass or sleeve gastrectomy), selected following the criteria of the International Federation of Obesity Surgery (IFSO) for bariatric surgery, such as body mass index (BMI) > 40 kg/m2 or BMI > 35 kg/m2 with significant, obesity related comorbidity. OSA is defined as periodic reduction (hypopnea) or cessation (apnea) of breathing, caused by partial or complete occlusion of the upper a

Interventions

Morbid obese patients undergoing bariatric surgery will be monitored by continuous pulse oximetry 24h post-operatively (Intervention). This perioperative management of OSA will be compared to pre-oper

Eligibility

Inclusion criteria

Inclusion criteria: - Scheduled for gastric bypass or sleeve gastrectomy - BMI ≥ 35 kg/m2 (IFSO criteria for bariatric surgery) - Age: 18-65 years

Exclusion criteria

Exclusion criteria: - BMI 65 years - Previous bariatric surgery - Unable to speak or read the Dutch language

Design outcomes

Primary

Measure	Time frame
Cost-effectiveness measured by: -Quality-adjusted-life-years (QALY¡¯s) calculated with the European Quality of Life-5 Dimensions (EQ-5D) -Productivity cost questionnaire (PCQ) -Use of health care resources.	—

Secondary

Measure	Time frame
Pulmonary/cardiac/neurovascular complications Length of hospital stay Morbidity Mortality Generic quality of life: RAND-36 OSA-related quality of life: FOSQ-10 questionnaires CPAP compliance Resolution of OSA symptoms: Epworth Sleepiness Scale ¡°ESS¡± Weight loss Postoperative hypoxemic episodes during the first night after bariatric surgery: - Mean SpO2 -Number of episodes SpO2 < 90% -Number of episodes SpO2 4% below baseline saturation -Duration of desaturations -Lowest SpO2	—

Measure

Time frame

Pulmonary/cardiac/neurovascular complications Length of hospital stay Morbidity Mortality Generic quality of life: RAND-36 OSA-related quality of life: FOSQ-10 questionnaires CPAP compliance Resolution of OSA symptoms: Epworth Sleepiness Scale ¡°ESS¡± Weight loss Postoperative hypoxemic episodes during the first night after bariatric surgery: - Mean SpO2 -Number of episodes SpO2 < 90% -Number of episodes SpO2 4% below baseline saturation -Duration of desaturations -Lowest SpO2

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Contacts

Public ContactS.L. Veldhuisen, van

Department of Surgery, Rijnstate Hospital

svanveldhuisen@rijnstate.nl+31 880055970

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)