Autotitrating Versus Standard Non-invasive Ventilation (NIV) in Acute Exacerbation of Respiratory Failure
Autotitrating Non-invasive Ventilation (NIV) Versus Standard NIV; a Randomised Crossover Trial in Patients With Acute Exacerbation of Chronic Respiratory Failure
The aim of the study is to compare the efficacy and tolerance of autotitrating non-invasive ventilation (NIV) versus standard NIV in patients admitted to hospital with acute exacerbation of chronic respiratory failure.
The investigators hypothesise that autotitrating NIV will ventilate patients with acute exacerbations of chronic respiratory failure as effectively as standard NIV.
연구 개요
상세 설명
The aim of the study is to compare the effect of two types of noninvasive ventilator (a small machine that assists breathing) in patients admitted to hospital with a sudden worsening of their existing breathing insufficiency, including an increase of carbon dioxide in the blood (hypercapnia) and acidity of the blood. Noninvasive ventilation (NIV) is standard therapy for patients with acute hypercapnic exacerbations (sudden worsening of existing breathing insufficiency) of both chronic obstructive pulmonary disease (COPD) and nonCOPD patients.
The most common type of NIV is bilevel pressure support which assists patient breathing by delivering different levels of air pressure during inspiration and expiration via a mask covering the nose or nose and mouth. Standard bilevel NIV (VPAP™) has been further developed to create a new automatically adjusting NIV (AutoVPAP™). Automatically adjusting NIV varies the inspiratory air pressure according to the airflow rates generated by the patient. This may improve patient comfort, hours of NIV use and recovery time.
Patients over the age of 18 admitted to Royal Brompton Hospital respiratory ward will be considered for entry into this randomised crossover study. If eligible for inclusion and willing to take part patients will be setup on automatically adjusting NIV or standard NIV, assigned in random order. After 24 hours on the first NIV the patient will be swapped to the alternative NIV for a further 24 hours of treatment.
연구 유형
단계
- 해당 없음
연락처 및 위치
연구 장소
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London, 영국, SW3 6NP
- Royal Brompton Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- patients admitted or transferred to Royal Brompton Hospital with acute exacerbation of chronic respiratory failure, or inpatients who suffer a deterioration in respiratory status, defined as 7.25 < pH < 7.35, PaCO2 > 6.0kPa, and respiratory rate > 20bpm
Exclusion Criteria:
- < 18 years old
- pH < 7.25
- need for immediate intubation
- uncontrolled cardiac failure
- hypotensive (systolic blood pressure < 90mmHg)
- acute myocardial infarction
- acute dysrhythmia
- other system failure (e.g. acute renal failure, liver failure)
- moderate or severe bulbar weakness
- inability to understand rationale and/or consent form for study
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: autotitrating NIV
approximately 24 hours using autotitrating non-invasive ventilation for as many hours as possible whilst an inpatient in hospital
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Automatically titrated non-invasive ventilator, with target gross alveolar ventilation, end expiratory positive pressure, and back up respiratory rate determined by the clinician based on height and weight.
The NIV must be used for as many hours as possible over the 24 hour period but breaks for meals, physiotherapy and bathroom are allowed.
다른 이름들:
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활성 비교기: Standard non-invasive ventilation
approximately 24 hours using standard non-invasive ventilation for as many hours as possible whilst an inpatient in hospital.
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Standard non-invasive ventilator, with inspiratory and expiratory positive pressure determined by the healthcare professional.
The NIV must be used for as many hours as possible over the 24 hour period but breaks for meals, physiotherapy and bathroom are allowed.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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pH at 1+ hour
기간: 1 hour
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pH of arterial blood after 1 hour of treatment with non-invasive ventialtion compared baseline value
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1 hour
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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pH at 4+ hours
기간: 4+ hours of NIV treatment
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pH of arterial blood after 4 hours of treatment with non-invasive ventialtion compared to baseline value
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4+ hours of NIV treatment
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Respiratory Rate at 1+ hour
기간: 1+ hour of NIV treatment
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Respiratory rate after 1 hour of treatment with non-invasive ventilation compared to baseline value
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1+ hour of NIV treatment
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Respiratory rate at 4+ hours
기간: 4+ hours of NIV treatment
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Respiratory rate after 4 hours of treatment with non-invasive ventilation compared to baseline value
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4+ hours of NIV treatment
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overnight mean transcutaneous carbon dioxide
기간: 24 hours
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mean overnight transcutaneous carbon dioxide during sleep period
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24 hours
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PaCO2 at 1+ hours
기간: 1+ hours of NIV treatment
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Carbon dixoide level of arterial blood after 1 hour of treatment with non-invasive ventilation compared to baseline
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1+ hours of NIV treatment
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PaCO2 at 4+ hours
기간: 4+ hours of NIV treatment
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Carbon dioxide level in arterial blood after 4 hours of treatment with non-invasive ventilation compared to baseline value
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4+ hours of NIV treatment
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PaO2 at 1+ hour
기간: 1+ hour of NIV treatment
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Oxygen level in arterial blood after 1 hour of treatment with non-invasive ventilation compared to baseline value
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1+ hour of NIV treatment
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PaO2 at 4+ hours
기간: 4+ hours of NIV treatment
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Oxygen level in arterial blood after 4+ hours of treatment with non-invasive ventilation compared to baseline value
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4+ hours of NIV treatment
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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 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 10/H0808/56
- R&D No. 2010LF008B (기타 식별자: Research & Development Department, RBH)
- CI/2010/0027 (기타 식별자: Medicines & Healthcare Products Regularoty Agency (devices))
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