Inspiratory Flow Rate Capability in Pulmonary Fibrosis Patients
A Clinical Study on Inspiratory Flow Rate Capability in Pulmonary Fibrosis Patients
The goal of this observational study is to learn about the inspiratory flow rate capability in patients with pulmonary fibrosis (IPF or PPF) when using inhaler devices with different resistances. The main questions it aims to answer are:
What is the peak inspiratory flow rate (PIFR) that patients with pulmonary fibrosis can achieve through a medium-resistance inhaler device?
What is the peak inspiratory flow rate (PIFR) that patients with pulmonary fibrosis can achieve through a high-resistance inhaler device?
What is the inspiratory time (EIT) for each resistance level?
Participants will use a portable device called In-Check™ DIAL G16, which simulates the resistance of different dry powder inhalers. Each participant will perform two breathing tests at a medium-resistance setting and two breathing tests at a high-resistance setting, with a 2-minute rest between settings. The device measures how fast air is breathed in and how long each breath lasts.
This study will enroll 60 patients diagnosed with IPF or PPF at Shanghai Pulmonary Hospital. Participants will be involved for approximately 30 to 60 minutes, including training on how to use the device and the breathing tests. The study involves no drugs or invasive procedures.
연구 개요
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Jiuwu Bai
- 전화번호: +86 13651602925
- 이메일: yv59@163.com
연구 장소
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Shanghai Municipality
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Shanghai, Shanghai Municipality, 중국, 200433
- 모병
- Shanghai Pulmonary Hospital
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연락하다:
- Jiuwu Bai
- 전화번호: +86 13651602925
- 이메일: yv59@163.com
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-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Age 18-80 years (inclusive), either sex.
- Diagnosis of pulmonary fibrosis (IPF or PPF) according to the ATS/ERS/JRS/ALAT 2022 guidelines (with traceable diagnostic evidence such as medical records, confirmed by a radiologist).
- Forced vital capacity (FVC) ≥ 45% of predicted normal value within 2 months before screening.
- Diffusing capacity for carbon monoxide (DLCO) > 25% of predicted normal value within 2 months before screening.
- Voluntary participation with written informed consent.
Exclusion Criteria:
- Patients with impaired consciousness, dementia, or various psychiatric disorders.
- Patients unable to operate the inspiratory flow measurement device as instructed by the investigator.
- Patients with major diseases or conditions other than the IPF under study that, in the investigator's judgment, may put the patient at risk by participating in the trial.
- Any participant deemed unsuitable for enrollment by the investigator.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Pulmonary Fibrosis Patients
Patients aged 18-80 years with a diagnosis of idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF) according to the ATS/ERS/JRS/ALAT 2022 guidelines.
Participants will perform inspiratory flow tests using the In-Check™ DIAL G16 device at both medium-resistance and high-resistance settings.
No investigational drug or intervention is administered.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Peak Inspiratory Flow Rate (PIFR) at Medium Device Resistance
기간: Single visit (approximately 30-60 minutes)
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Peak inspiratory flow rate (PIFR, L/min) will be measured using the In-Check™ DIAL G16 device at the medium-resistance setting.
Each participant will perform two breathing tests at this setting.
The mean PIFR of the two valid measurements will be recorded.
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Single visit (approximately 30-60 minutes)
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Peak Inspiratory Flow Rate (PIFR) at High Device Resistance
기간: Single visit (approximately 30-60 minutes)
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Peak inspiratory flow rate (PIFR, L/min) will be measured using the In-Check™ DIAL G16 device at the high-resistance setting.
Each participant will perform two breathing tests at this setting.
The mean PIFR of the two valid measurements will be recorded.
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Single visit (approximately 30-60 minutes)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Inspiratory Time (EIT) at Medium and High Device Resistances
기간: Single visit (approximately 30-60 minutes)
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Inspiratory time (EIT, seconds) will be measured using the In-Check™ DIAL G16 device at two resistance settings: medium resistance and high resistance.
Each participant will perform two breathing tests at each resistance setting.
The mean EIT of the two valid measurements at each resistance level will be recorded and compared between the two settings.
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Single visit (approximately 30-60 minutes)
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- SHXHH-PF-DY-01
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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