- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01663480
To Identify the Proportionality of Respiratory Work Under Different NAVA Level
Assessment of Patient-ventilator Breath Contribution (PVBC) During Neurally Adjusted Ventilatory Assist (NAVA) in Patients With Acute Respiratory Failure
The primary purpose of mechanical ventilation is to sufficiently unload the respiratory muscles and maintain adequate ventilation in spontaneously breathing patients. When the mechanical ventilatory assist is synchronized to the patient's inspiratory effort, both the patient and the mechanical ventilator will contribute to the lung-distending pressure, necessary to overcome inspiratory load and generate the tidal volume (Vt). Unfortunately, conventional modes of mechanical ventilation cannot quantify the impact of the ventilatory assist performed by the ventilator and the patient. Inadequate levels of assist are associated with adverse effects such as development of fatigue or patient-ventilator dissynchrony and diaphragm impairment, and over assist also lead to diaphragm atrophy and weaning delay.
The newly introduced neurally adjusted ventilatory assist (NAVA) has made it possible to measure the neural activity of the respiratory centers (expressed by the diaphragm electrical activity, EAdi). EAdi is a validated variable to quantify the neural respiratory drive, little is known about its usefulness to evaluate the contribution of the patient's inspiratory muscle effort relative to that of the mechanical ventilator, which would be of crucial importance to appropriately titrate the level of assist.
During NAVA, the patient's efficiency to transform neural effort (EAdi) into Vt, expressed as neuroventilatory efficiency (NVE), may be a useful predictor for determining the contribution of the patient and the ventilator to generate a breath.
연구 개요
상태
정황
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Jiangsu
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Nanjing, Jiangsu, 중국, 210009
- Southeast Univerity
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:(1) Intubated or tracheostomied patients with ARF due to COPD (10 patients) or other reasons (10 patients) who were undergoing assisted mechanical ventilation, (2) be able to tolerate short time (30 minutes) spontaneous breathing (PEEP≤5cmH2O, without assist), (3) awake and do not need high dose of sedation
Exclusion Criteria:(1) age <18 or >80 years, (2) ready for extubation, (3) history of esophageal varices, (4) gastro-esophageal surgery in the previous 12 months or gastro-esophageal bleeding in the previous 30 days, (5) coagulation disorders (INR ratio>1.5 and APTT>44 s), (6) history of acute central or peripheral nervous system disorder or severe neuromuscular disease, (7) history of leukemia, severe chronic liver or chronic cardiac disease, (8) solid organ transplantation, (9) malignant tumor.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
PVBC index
기간: every 3 mins
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PVBC2predicts the contribution of the inspiratory muscles versus that of the ventilator during NAVA
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every 3 mins
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공동 작업자 및 조사자
스폰서
수사관
- 연구 책임자: Haibo Qiu, southeast univerity, China
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
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. .