- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03984175
Clinical Decision Support for Mechanical Ventilation of Patients With ARDS
Implementation of Computerized Clinical Decision Support for Mechanical Ventilation of Patients With Acute Respiratory Distress Syndrome
연구 개요
상세 설명
A multidisciplinary team of implementation researchers and clinical effectiveness researchers has been assembled to adapt the Consolidated Framework for Implementation Research (CFIR) for this planning study. The team identified the baseline clinical care delivery for LTVV in patients with ARDS across Intermountain hospitals and identified the barriers and facilitators to this standard of care. This pilot implementation study will focus on a Pilot Solution aimed at achieving ideal clinical care delivery of LTVV for patients with ARDS.
Abbreviations for Mechanical Ventilation:
PEEP: positive end expiratory pressure FIO2: fraction of inspired oxygen CPAP: continuous positive airway pressure PS: pressure support VC: volume control VC+: hybrid mode for volume targeted ventilation on Puritan Bennett ventilators PRVC: pressure regulated volume control, hybrid mode for volume targeted ventilation on Draeger ventilators PF ratio: ratio of partial pressure of arterial oxygen (PaO2 mmHg) divided by the FIO2 expressed in liters
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Colin K Grissom, MD
- 전화번호: 801-507-6554
- 이메일: colin.grissom@imail.org
연구 장소
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Utah
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Murray, Utah, 미국, 84107
- 모병
- Intermountain Medical Center
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연락하다:
- Valerie Aston
- 전화번호: 801-507-4606
- 이메일: valerie.aston@imail.org
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부수사관:
- Ithan Peltan, MD
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부수사관:
- Samuel Brown, MD
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부수사관:
- Lindsay Leither, DO
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부수사관:
- Michael Lanspa, MD
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부수사관:
- Joseph Bledsoe, MD
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부수사관:
- Scott Stevens, MD
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연락하다:
- Carlos Barbagelata
- 전화번호: 801-507-4607
- 이메일: carlos.barbagelata@imail.org
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부수사관:
- Lori Carpenter
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부수사관:
- Andrew Knighton, PhD
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부수사관:
- Scott Narus, MD
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부수사관:
- Rajendu Srivastava, MD
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Invasive mechanical ventilation
- PF ratio <255
- Bilateral infiltrates on chest radiograph (adjudicated by a co-investigator)
- Presence of ≥1 risk factor for ARDS as determined by review of the HER
Exclusion Criteria:
- Age <18 years
- Pulmonary capillary wedge pressure >18 mm Hg if a right heart catheter is present
- Prisoner
- Known to be pregnant
- Death <24 hours from initial intubation
- Placed comfort care <24 hours from initial intubation
- Mechanically ventilated for >7 days prior to meeting ARDS criteria
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Patients with ARDS at three Intermountain tertiary hospitals
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Implementation of processes to improve compliance with low tidal volume ventilation in patients with ARDS using a computerized protocol
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
LTVV Compliance
기간: through study completion - 6 months
|
Defined as: % of time each patient is on a compliant tidal volume for the duration of mechanical ventilation. Measured as: VC, PRVC, or VC+ with volume set to 6.5 ml/kg or less for each patient (proportion of mechanically ventilated hours, excluding hours on appropriate CPAP/PS) |
through study completion - 6 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
PEEP FI02 Compliance (continuous variable)
기간: through study completion - 6 months
|
Defined as: % of time each patient is on a compliant FI02 and PEEP combination. Measured as: using recommended (per most recently run oxygenation protocol) PEEP-FIO2 combinations, (proportion of ventilated hours, excluding the first four hours of mechanical ventilation and excluding hours on appropriate CPAP/PS) |
through study completion - 6 months
|
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Utilization of Ventilation Protocol (continuous)
기간: through study completion - 6 months
|
Defined as: % of time each patient is managed with the computerized ventilation protocol. Measured as: Running the computerized ventilation protocol whenever a ventilator check is performed and an arterial blood gas was done within the previous hour, excluding hours on appropriate CPAP/PS |
through study completion - 6 months
|
|
Utilization of Oxygenation Protocol (continuous)
기간: through study completion - 6 months
|
Defined as: % of time each patient is managed with the computerized oxygenation protocol. Measured as: Running the computerized oxygenation protocol at least every four hours when a ventilator check was performed, excluding hours on appropriate CPAP/PS |
through study completion - 6 months
|
|
LTVV Compliance >90% (binary)
기간: through study completion - 6 months
|
Defined as: meeting, or not meeting, the target LTVV compliance of >90% for each patient. Measured as: VC, PRVC, or VC+ with volume set to 6.5 ml/kg or less for 90% or more of mechanically ventilated hours, excluding hours on appropriate CPAP/PS |
through study completion - 6 months
|
|
PEEP FI02 Compliance >70% (binary)
기간: through study completion - 6 months
|
Defined as: meeting, or not meeting, the target PEEP FI02 compliance of >70% for each patient. Measured as: Using recommended (per most recently run oxygenation protocol) PEEP-FIO2 combinations for at least 70% of mechanically ventilated hours (excluding the first four hours of mechanical ventilation and excluding hours on appropriate CPAP/PS) |
through study completion - 6 months
|
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Ventilator-Free Days (VFD) to Day 28
기간: through study completion - 6 months
|
through study completion - 6 months
|
|
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% of Patients who do not survive to day 28
기간: through study completion - 6 months
|
through study completion - 6 months
|
공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- 1050867
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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