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临床试验/NCT07020689
NCT07020689已完成不适用

Combined Airway & Bariatric Surgery (CABS) for Obesity Hypoventilation Syndrome

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2022年9月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
36
试验地点
1
主要终点
AHI

研究概览

简要总结

The aims of this prospective observational cohort study are threefold: (1) to assess the prevalence of obesity hypoventilation syndrome (OHS) in individuals with obesity and obstructive sleep apnea (OSA) and identify associated risk factors, (2) to determine clinical predictors of OHS, and (3) to evaluate the therapeutic outcomes of combined airway and bariatric surgery (CABS) in this population.

详细描述

This study was approved by the Institutional Review Board of Chang Gung Medical Foundation on August 8, 2022 (IRB No. 202201000A3). Written informed consent was obtained from all participants. All procedures adhered to the principles outlined in the Declaration of Helsinki and were reported in accordance with the Strengthening the Reporting of Observational Studies in Epidemiology (STROCSS) guidelines.

This was a two-year prospective observational cohort study conducted at the tertiary referral sleep center of Linkou Chang Gung Memorial Hospital from December 1, 2022, to November 30, 2024. Obesity hypoventilation syndrome (OHS) was diagnosed based on the presence of BMI ≥ 30 kg/m², PaCO₂ ≥ 45 mmHg on arterial blood gas (ABG) analysis, and sleep-disordered breathing, following the exclusion of other potential causes of alveolar hypoventilation using pulmonary function tests.

Adults aged 20 to 65 years were eligible if they met the following inclusion criteria: (1) BMI ≥ 30 kg/m², and (2) AHI ≥ 5 events/hour. Individuals were excluded if they had (1) persistent decompensated hypercapnic respiratory failure (arterial pH < 7.3), (2) acute respiratory failure requiring invasive mechanical ventilation, (3) significant neuromuscular disease, chest wall deformities, or pulmonary disease contributing to hypoventilation, (4) unstable coronary artery disease, or (5) cognitive impairment precluding informed consent or protocol adherence.

Following diagnosis, individuals with OHS were counseled on therapeutic options, including continuous positive airway pressure (CPAP) therapy, body weight reduction, or combined airway and bariatric surgery (CABS). The final decision was made through a shared decision-making process.

Outcome measures included (1) Polysomnography: All participants underwent attended level I polysomnography using the Nicolet UltraSom System (Nicolet, Madison, WI). AHI was the primary sleep parameter, defined as the total number of apneas (≥ 90% airflow reduction for ≥10 seconds) and hypopneas (> 50% airflow reduction with ≥ 3% oxygen desaturation or arousal) per hour of sleep. Scoring was performed by a single blinded sleep specialist. (2) Pulmonary function testing: Spirometry was performed using a handheld spirometer in accordance with international guidelines. Parameters included forced vital capacity (FVC), forced expiratory volume in 1 second (FEV₁), and FEV₁/FVC ratio. (3) Gas exchange: ABG analysis was conducted during daytime hours with the participant seated and breathing room air after resting for at least 60 minutes. (4) Epworth sleepiness scale: Daytime sleepiness was assessed using the Epworth Sleepiness Scale (ESS), a validated 8-item questionnaire with total scores ranging from 0 to 24; higher scores indicate greater daytime sleepiness.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • (1) BMI ≥ 30 kg/m², and (2) AHI ≥ 5 events/hour.

排除标准

  • (1) persistent decompensated hypercapnic respiratory failure (arterial pH < 7.3), (2) acute respiratory failure requiring invasive mechanical ventilation, (3) significant neuromuscular disease, chest wall deformities, or pulmonary disease contributing to hypoventilation, (4) unstable coronary artery disease, or (5) cognitive impairment precluding informed consent or protocol adherence.

结局指标

主要结局

AHI

时间窗: From enrollment to the end of treatment at 12 months.

All participants underwent attended level I polysomnography using the Nicolet UltraSom System (Nicolet, Madison, WI). Apnea-hypopnea index (AHI) was the primary sleep parameter, defined as the total number of apneas (≥ 90% airflow reduction for ≥10 seconds) and hypopneas (\> 50% airflow reduction with ≥ 3% oxygen desaturation or arousal) per hour of sleep. Scoring was performed by a single blinded sleep specialist.

次要结局

  • FEV₁/FVC ratio(From enrollment to the end of treatment at 12 months.)
  • PaCO₂(From enrollment to the end of treatment at 12 months)
  • ESS score(From enrollment to the end of treatment at 12 months.)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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