Exercise Induced Laryngeal Obstruction; a Randomized Controlled Treatment Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 350
- 试验地点
- 2
- 主要终点
- Pulmonary function and exercise test - Spirometry 2
研究概览
简要总结
Exercise induced laryngeal obstruction (EILO) is a common cause of exertional breathing problems in young individuals, caused by paradoxical inspiratory adduction of laryngeal structures, and diagnosed by continuous visualization of the larynx during high intensity exercise.
详细描述
Exercise induced laryngeal obstruction (EILO) is a common cause of exertional breathing problems in young individuals, caused by paradoxical inspiratory adduction of laryngeal structures, and diagnosed by continuous visualization of the larynx during high intensity exercise.
Studies indicate that EILO responds positively to treatment interventions; however, the investigators lack randomized controlled studies to confirm this (10-15). This study aims to provide evidence-based information on interventions commonly applied to treat EILO. Background: Exercise induced laryngeal obstruction (EILO) is a common cause of exertional breathing problems in young individuals, caused by paradoxical inspiratory adduction of laryngeal structures, and diagnosed by continuous visualization of the larynx during high intensity exercise. Empirical data suggest that EILO consists of different subtypes that require different therapeutic approaches. However, currently applied treatment schemes do not rest on randomized controlled trials. This study aims to provide evidence-based information on treatment schemes commonly applied in patients with EILO.
Methods: Consenting patients consecutively diagnosed with EILO at Haukeland University Hospital will be randomized into four different conservative treatment arms, selected on the basis of promising reports from non-randomized studies: (A) standardized information and breathing advice only (IBA), (B) IBA plus inspiratory muscle training, (C) IBA plus speech therapy, and (D) IBA plus provision of both inspiratory muscle training and speech therapy. Differential effects in predefined EILO subtypes will be addressed. Patients failing the conservative approach and otherwise qualifying for surgical treatment by current department policy will be considered for randomization into (E) standard or (F) minimal laser supraglottoplasty, and a "wait-and-see" control group. Power calculations will be based on the main outcomes, laryngeal adduction during peak exercise, rated by a validated scoring system before and after the interventions.
Discussion: The study will provide evidence-based information on the treatment of EILO, listed as a priority in a recent statement issued by the European Respiratory Society, requested by clinicians and researchers engaged in this area, and relevant to 5-7% of young people.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •EILO with CLE score at peak exercise graded as ≥ 2 at glottic or supraglottic level and
- •Respiratory complaints to an extent that the patient wants further treatment and follow-up.
排除标准
- •Breathing problems caused by disorders other than EILO or well controlled asthma.
- •Perceived to be unable to perform repeated maximal cardiopulmonary treadmill exercise tests, or failing to accept the procedures required for repeated successful CLE tests, or unable to perform any of the other examinations required by the protocol.
- •Abnormal anatomy at rest in the laryngeal region or the upper airways.
- •Age below 12 years
结局指标
主要结局
Pulmonary function and exercise test - Spirometry 2
时间窗: Through study completion, on average 6 months
Recording of expiratory and inspiratory volumes and flows will be recorded: forced expiratory and inspiratory volume in first second (FEV1 and FIV1). Volumes measured in liters
Cardiopulmonary exercise (CPX) data - heart rates.
时间窗: Through study completion, on average 6 months
A treadmill will run according to a modified Bruce protocol, incrementing speed and/or grade every 1 min, aiming for peak oxygen uptake after 6-14 min. Variables of heart rates will be recorded in Hf/min.
Cardiopulmonary exercise (CPX) data - Variables of gas exchange
时间窗: Through study completion, on average 6 months
A treadmill will run according to a modified Bruce protocol, incrementing speed and/or grade every 1 min, aiming for peak oxygen uptake after 6-14 min. Variables of gas exchange are measured breath-by-breath. Oxygen absorption measured in mL(min)/kg. Co2 production and O2 production in mL/min.
Cardiopulmonary exercise (CPX) data - distance of run
时间窗: Through study completion, on average 6 months
A treadmill will run according to a modified Bruce protocol, incrementing speed and/or grade every 1 min, aiming for peak oxygen uptake after 6-14 min. Distance of run is recorded in meters
Cardiopulmonary exercise (CPX) data - respiratory rates.
时间窗: Through study completion, on average 6 months
A treadmill will run according to a modified Bruce protocol, incrementing speed and/or grade every 1 min, aiming for peak oxygen uptake after 6-14 min. Variables of respiratory and tidal volumes will be recorded in liters and ratios calculated.
Continuous laryngoscopy exercise (CLE) with pressure recordings
时间窗: During Phase 3, average duration 6 months.
Translaryngeal resistance will be measured during CLE-testing in the third phase. Calculation of resistance will be based on pressure recordings obtained by two pressure sensors placed above and below the larynx, and airflow measured breath by breath by the mouth. Pressure is measured in kPa.
Questionnaires
时间窗: Day 1
All patients will complete custom-made questionnaires recording demographic background variables and symptom scores. The questionnaires focus mainly on respiratory symptoms experienced by the patients, treatment they have been exposed to, and diagnoses they have been assigned. Relevant co-morbidities will also be recorded.
Pulmonary function and exercise test - Spirometry 3
时间窗: Through study completion, on average 6 months
Recording of expiratory and inspiratory volumes and flows will be recorded: forced expiratory and inspiratory flow at 50% of FVC (FEF and FIF50) and at 25-75% of FVC (FEF and FIF25-75). Volumes measured in liters.
Continuous Laryngoscopy Exercise test (CLE-test) and scoring
时间窗: Through study completion, on average 6 months
CLE-scores from the video recordings from the CLE-test will be evaluated. Two highly experienced raters will score all CLE tests according to a system that has been published previously. CLE scoring of glottic and supraglottic obstruction, grades 0 to 4.
Cardiopulmonary exercise (CPX) data - CO2 production
时间窗: Through study completion, on average 6 months
A treadmill will run according to a modified Bruce protocol, incrementing speed and/or grade every 1 min, aiming for peak oxygen uptake after 6-14 min. Variables of CO2 production will be recorded in mL/minute.
Pulmonary function and exercise test - Spirometry 1
时间窗: Through study completion, on average 6 months
Recording of expiratory and inspiratory volumes and flows will be recorded: Forced expiratory and inspiratory volume capacity (FVC and FIVC). Volumes measured in liters
Cardiopulmonary exercise (CPX) data - duration of run
时间窗: Through study completion, on average 6 months
A treadmill will run according to a modified Bruce protocol, incrementing speed and/or grade every 1 min, aiming for peak oxygen uptake after 6-14 min. Duration of run is recorded in minutes and seconds.
Cardiopulmonary exercise (CPX) data - oxygen consumption
时间窗: Through study completion, on average 6 months
A treadmill will run according to a modified Bruce protocol, incrementing speed and/or grade every 1 min, aiming for peak oxygen uptake after 6-14 min. Variables of oxygen consumption will be recorded. Oxygen consumption is measured in (mL/min)/kg
Cardiopulmonary exercise (CPX) data - Exercise tidal flow/volume loops
时间窗: Through study completion, on average 6 months
A treadmill will run according to a modified Bruce protocol, incrementing speed and/or grade every 1 min, aiming for peak oxygen uptake after 6-14 min. Exercise tidal flow/volume loops will be obtained at fixed interval during the session by plotting air flow (l/sec) and air volume the patient breathes during testing.
次要结局
未报告次要终点