- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04350970
High-flow Nasal Cannula and Exercise Tolerance in COPD
Acute Effects of High-flow Nasal Cannula and Non-invasive Ventilation on Constant-load Exercise Tolerance in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
연구 개요
상세 설명
The patients underwent an initial clinical examination, with anthropometric evaluation, blood gas analysis, pulmonary function tests and measurement of maximum respiratory pressures. The exercise protocol started in the sector of Ergometry and Cardiopulmonary Exercise Testing. After completing the maximum incremental cardiopulmonary exercise test, two additional visits were scheduled for the three constant load tests. All patients studied underwent an evaluation of cardiopulmonary exercise testing (CPET). During maximum-incremental CPET, breath by breath: oxygen consumption (V̇O2, mL/min), carbon dioxide production (V̇CO2, mL/min), respiratory exchange rate (RER), minute ventilation VE (L/min), respiratory rate (bpm), equivalent ventilation for O2 and CO2 (V̇E/V̇O2 and V̇E/V̇CO2). In addition, cardiac monitoring was performed by 12-lead electrocardiogram (ECG) throughout the procedure. On the day of the experiment, the patients underwent two cardiopulmonary exercises with constant-load at 90% of the previously determined peak, separated by an interval of at least 1 hour.
The NIV parameters were adjusted for each patient with Trilogy 100 (Philips™). Spontaneous ventilation mode was set before the protocol for all patients, and a previous period of NIV adaptation was performed to titrate the inspiratory and expiratory pressures. The adaptation period started with the minimum Inspiratory Positive Airway Pressure (IPAP) value of 15cmH2O, and, every 2 minutes, increasing the pressure every 2 cmH2O according to the patient's tolerance.16 The Expiratory Positive Airway Pressure (EPAP) was programmed to vary between 4 and 6 cmH2O. Before the start of the examination, an adaptation was performed with the selected mask and initial ventilator settings for 20 min. No additional oxygen was offered.
The high flow system used was Optiflow® (Fisher & Paykel Healthcare, Auckland, New Zealand). Before the test, flow titration was performed for the patient, which started with the administration of a minimum gas flow of 30L/min and, every 2 minutes, the flow was increased by 5L/min according to patient tolerance. The test only started after 20 minutes of adaptation.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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CE
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Fortaleza, CE, 브라질, 60.430-370
- Federal University of Ceará
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Previous COPD
- FEV1 ≤ 50%
- Optimized medication
Exclusion Criteria:
- COPD Exacerbation
- Cardiac disease
- Previous neurologic disorders
- Unable to complete all protocol
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Control
The cardiopulmonary exercise test was performed with patient breathing room air.
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All patients underwent two cardiopulmonary exercises with constant-load at 90% of the peak workload.
The control test was performed with no additional therapy.
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활성 비교기: NIV
The cardiopulmonary exercise test was performed with non-invasive ventilation during the test.
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All patients underwent two cardiopulmonary exercises with constant-load at 90% of the peak workload.
The NIV was used during all exercise test.
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활성 비교기: HFNT
The cardiopulmonary exercise test was performed with a High flow nasal therapy during the test.
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All patients underwent two cardiopulmonary exercises with constant-load at 90% of the peak workload.
The high flow nasal therapy was used during all exercise test.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Exercise dinamic hyperinflation
기간: one week after all tests
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To determine the dinamic hyperinflation during exercise test with 3-different situations , Control, NIV and HFNT.
During all testes the dinamic hyperinflation will be measured by inspiratory capacity (at rest and at the end o exercise test) and will be demonstrated as porcentage os maximum.
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one week after all tests
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Exercise Tolerance
기간: one week after all tests
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To determine the exercise tolerance with 3-different situations , Control, NIV and HFNT.
Time of exercise test will be measured to determine which test could be the best for COPD patients.
In additional, the workload will (treadmill inclination and speed) be check to show which intervention has the better response.
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one week after all tests
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Dyspnea
기간: one week after all tests
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To determine the dyspnea during exercise test with 3-different situations , Control, NIV and HFNT.
After all situations, Borg scale will be performed to check the dyspnea score at the end of exercise.
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one week after all tests
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
- 3.009.159
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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