A Study of Characteristics of Forced Oscillometry In Patients with Interstitial Lung Disease.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- To compare reactance at 5 Hz (X5) determined by Forced
研究概览
简要总结
1.All newly diagnosed patients of Interstitial lung disease satisfying the inclusion criteria will be enrolled in the study after obtaining written informed consent.
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Healthy individuals from community will be enrolled in the study after obtaining written informed consent.
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Demographic details, and anthropometric data of cases with ILD and healthy individuals will be recorded on a predesigned proforma.
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Clinical data, Forced Vital Capacity from Spirometry, Total lung capacity from body plethysmography and six-minute walk distance from six minute walk test of cases with ILD will be noted.
5.Enrolled participants will undergo Forced oscillometry
according to the current European Respiratory Society guidelines.5 Forced Oscillometry device will be preformed using Tremoflo C100 airway oscillometry system, Thorasys,Montreal,Quebec,Canada,in accordance with the recent ERS
guidelines.
I. After explaining the technique, the participant will be allowed to breathe normally into the system.
II. A minimum of three tests, each of 30 s duration, will be performed for each participant.
III. Participants will be seated comfortably throughout, holding their heads in a neutral position and wear nose clips.
IV. The participant will be asked to place their hands firmly on their cheeks to minimize the shunt effect of the upper airways.
V. Participants will be instructed to keep their mouth tightly sealed around the mouthpiece and to keep their tongue low in the mouth by tucking it under the mouthpiece.
VI. They will also be asked to avoid swallowing or talking.. Participants will be encouraged quietly throughout each test, to reassure them and to ensure as much freedom from technical errors as possible.
- X5 inspiratory and expiratory reactance, resonant frequency, reactance area will be measured.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Cases: Already diagnosed cases of Interstitial lung disease.
- •Patients providing prior written informed consent Controls: Healthy adults above 18 years of age without symptoms of any respiratory disease like shortness of breath, cough, expectoration, wheezing, pleuritic chest pain and who are not a known case of any respiratory disease.
排除标准
- •Patients with concomitant respiratory diseases that could interfere with the results (malignancies, heart failure, emphysema, chest wall deformity, neuromuscular diseases, etc.)
- •Patients requiring oxygen at rest
- •Those not able to perform Forced Oscillometry, Spirometry,Lung volume estimation by Body Plethysmography, six minute walk test.
结局指标
主要结局
To compare reactance at 5 Hz (X5) determined by Forced
时间窗: At baseline
oscillometry technique between patients with ILD and healthy
时间窗: At baseline
individuals.
时间窗: At baseline
次要结局
未报告次要终点
研究者
Heyma krishna Manoharan
AIIMS Rajkot, Gujarat