Feasibility of Constant Work Rate Testing to Detect Exercise-induced Laryngeal Obstruction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- prevalence and degree of glottic or supraglottic collapse in EILO patients
研究概览
简要总结
TITLE Feasibility of constant work rate testing to detect exercise-induced laryngeal obstruction
DESIGN Prospective observational pilot study
AIMS To investigate if constant work rate testing at different work rates will sufficiently induce detectable exercise-induced laryngeal obstruction (EILO) using CLE.
POPULATION Adult patients with EILO
DURATION 01.09.2022 - 30.06.2023
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is willing and able to give informed consent for participation in the study.
- •Male or Female, aged 18 or above with a clinical suspicion of having EILO.
- •Individuals with concurrent asthma can participate in the study provided that their asthma is well-controlled, determined by a negative bronchoprovocation test.
排除标准
- •No EILO found in Clinical standard-of-care CLE test
- •Not able to complete the exercise test for other reasons than breathlessness or leg fatigue (e.g. injury, disease or disability preventing cycling to maximal exertion).
- •Comorbidities other than asthma, which, judged by the investigator, might confound the test results or pose a medical risk to the patient (e.g. cardiac disease, exercise-induced anaphylaxis).
- •Current smokers (< 6 months of stopping) or individuals with a significant smoking history (>10 pack years).
- •Pregnancy.
结局指标
主要结局
prevalence and degree of glottic or supraglottic collapse in EILO patients
时间窗: Changes from baseline during the procedure and immediately after cessation of the exercise test.
Laryngoscopic detection of supraglottic or a glottic obstruction of the same severity as observed during incremental testing, during a submaximal constant work rate exercise test (70 %, 80 % and 90 %) using a visual grade scale (0-3, with 0 reflecting no obstruction, and 3 being the most severe degree of obstruction).
Time of onset of the laryngeal obstruction
时间窗: A time of onset determined during the procedures
A specific point in time where observed laryngeal obstruction is first discernible will be determined during the evaluation of the laryngoscopic videos. This is to descriptively quantify this outcome.
Observed duration of the laryngeal obstruction
时间窗: Duration measured in seconds during the procedures
The investigators will further evaluate the laryngoscopic videos and determine the duration of the participant's laryngeal obstruction. This duration is defined as the time period from the time of onset during submaximal exercise, until remission of the observed obstruction or end of the test.
次要结局
- Patient reported symptom scores: Nijmegen(At baseline)
- Patient reported symptom scores: Multidimensional Dyspnoea Profile (MDP).(At baseline)
- Patient reported symptom score: Dyspnoea-12(At baseline)
- Leg fatigue scores during exercise(At baseline and at one minute intervals during the CLE tests (up to 60 minutes))
- Rate of perceived exertion (RPE) scores during exercise(At baseline and at one minute intervals during the CLE tests (up to 60 minutes))
- Inter-rater agreement of the prevalence and degree of glottic or supraglottic collapse in EILO patients(During data analysis (month 1).)
- Modified borg dyspnoea during exercise(At baseline and at one minute intervals during the CLE tests (up to 60 minutes))
研究者
Emil Walsted
Principal Investigator
Bispebjerg Hospital