HFCWO in Prolonged Mechanical Ventilation Patients
2014년 3월 2일 업데이트: TCVGH, Taichung Veterans General Hospital
High-frequency Chest Wall Oscillation in Prolonged Mechanical Ventilation Patients-a Randomized Controlled Trial
The effectiveness, safety and tolerance/comfort of high-frequency chest wall oscillation (HFCWO) in prolonged mechanical ventilation patients remain unknown.
This study aimed to test the hypothesis that HFCWO could produce greater clearance volume of sputum, greater improvement rates in serial changes in the chest X-ray (CXR), and greater weaning success rates after extubation in Prolonged Mechanical Ventilation (PMV) patients with intra-tracheal intubation.
연구 개요
상세 설명
For over 20 years, studies have attempted to examine the effectiveness, safety and tolerance/comfort of HFCWO in the management of surgical and non-surgical patients who had impaired bronchial secretion clearance, including those with neuromuscular disorders, chronic obstructive pulmonary disease, cystic fibrosis, and blunt thoracic trauma, or those hospitalized for critical cardiac/abdominal/thoracic surgery. However, these outcomes of HFCWO on PMV patients remain unknown.
This parallel-design, randomized controlled trial aimed to test the hypothesis that HFCWO could produce greater clearance volume of sputum, greater improvement rates in serial changes in the chest X-ray (CXR), and greater weaning success rates after extubation in PMV patients with intra-tracheal intubation. Moreover, the safety and tolerance/comfort of HFCWO in PMV patients after removal of endotracheal tubes were also evaluated.
연구 유형
중재적
등록 (실제)
45
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Taichung, 대만, 40705
- Taichung Veterans General Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
20년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- continuous intra-tracheal intubation and mechanical ventilator support for at least 21 days
- age ≥20 year-old
- having an acute or chronic pulmonary condition requiring secretion mobilization as judged by the physician
- alert consciousness; completion of the Modified Borg Scale (MBS) and Hamilton Anxiety Scale (HAS)
- scheduled extubation within 24 hours after enrollment
- without any contraindication for HFCWO (i.e., recent spinal injuries which have not yet been stabilized and active hemorrhage with hemodynamic instability)
Exclusion Criteria:
1. those who had undergone tracheostomy
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: HFCWO
HFCWO for 15 min twice a day
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study subjects in the HFCWO group received HFCWO for 15 min twice a day for 5 days after extubation
다른 이름들:
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위약 비교기: placebo
not to receive high-frequency chest wall oscillation (HFCWO)
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Effectiveness as determined by weaning success rates
기간: up to 5 days after extubation
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Successful weaning was defined as continuous liberation from mechanical ventilator support longer than 5 days.
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up to 5 days after extubation
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Effectiveness as determined by daily clearance volume of sputum
기간: up to 5 days after extubation
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The daily clearance volume of sputum was determined by the numbers of sputum suction per day
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up to 5 days after extubation
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Effectiveness as determined by serial changes in sputum coloration
기간: up to 5 days after extubation
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The sputum coloration was determined by the Color Card for Body Fluid (CCBF).
The CCBF was designed to have 27 different categories to describe the color of the body fluid.
Each category was assigned an Arabic numeral and the larger the Arabic numeral, the darker the color of the body fluid.
The scoring of sputum coloration was based on the perception of the interviewer who was blinded to the intervention.
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up to 5 days after extubation
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Effectiveness as determined by chest X-ray improvement rates
기간: up to 5 days after extubation
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Baseline and follow-up CXRs were taken on the day of extubation and on the 5th day after extubation, respectively, in both groups.
Serial changes in CXR were graded as "improved", "no change", or "progressed", as determined by the severity of lung infiltrates, which were defined by two independent chest specialists blinded to the study groupings.
If no consistency between two specialists, the grading would be judged by the third chest specialist.
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up to 5 days after extubation
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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safety as determined by the changes of blood pressures before and after HFCWO
기간: up to 5 days after extubation
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systolic blood pressure (SBP) and diastolic blood pressure (DBP) were recorded before and after each HFCWO treatment by nurses who were unblinded to the study groupings.
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up to 5 days after extubation
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safety as determined by the changes of heart rates before and after HFCWO
기간: up to 5 days after extubation
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Heart rates (HR) was recorded before and after each HFCWO treatment by nurses who were unblinded to the study groupings.
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up to 5 days after extubation
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safety as determined by the changes of respiratory rates (RR) before and after HFCWO
기간: up to 5 days after extubation
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Respiratory rates (RR) were recorded before and after each HFCWO treatment by nurses who were unblinded to the study groupings.
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up to 5 days after extubation
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safety as determined by the changes of oxyhemoglobin saturations by pulse oximetry (SpO2) before and after HFCWO
기간: up to 5 days after extubation
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Oxyhemoglobin saturations by pulse oximetry (SpO2) were recorded before and after each HFCWO treatment by nurses who were unblinded to the study groupings.
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up to 5 days after extubation
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tolerance/comfort as determined by Modified Borg Scale (MBS)
기간: up to 5 days after extubation
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MBS was measured before and after treatment in HFCWO group and at the same time in non-HFCWO group by the interviewer who was blinded to the intervention from the day of extubation to the 5th post-extubation day.
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up to 5 days after extubation
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tolerance/comfort as determined by Hamilton Anxiety Scale (HAS)
기간: up to 5 days after extubation
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HAS was measured before and after treatment in HFCWO group and at the same time in non-HFCWO group by the interviewer who was blinded to the intervention from the day of extubation to the 5th post-extubation day.
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up to 5 days after extubation
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Chieh-Liang Wu, Ph.D., Taichung Veterans General Hospital
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2011년 1월 1일
기본 완료 (실제)
2012년 12월 1일
연구 완료 (실제)
2012년 12월 1일
연구 등록 날짜
최초 제출
2014년 2월 20일
QC 기준을 충족하는 최초 제출
2014년 3월 2일
처음 게시됨 (추정)
2014년 3월 4일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2014년 3월 4일
QC 기준을 충족하는 마지막 업데이트 제출
2014년 3월 2일
마지막으로 확인됨
2014년 3월 1일
추가 정보
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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