Checklists and Upright Positioning in Endotracheal Intubation of Critically Ill Patients (Check-UP) Trial (Check-UP)
2016년 9월 16일 업데이트: Todd Rice, Vanderbilt University
The use of a written, pre-procedure checklist and positioning the patient with the head of the bed elevated have been proposed as interventions capable of preventing complications during non-elective intubation and are used intermittently in routine care -- however neither have been examined in a prospective trial.
연구 개요
상세 설명
Endotracheal intubation is common in the care of critically ill patients.
Procedural complications including hypoxia and hypotension are frequent in urgent and emergent intubation and associated with an increased risk of death.
The use of a written, pre-procedure checklist and positioning the patient with the head of the bed elevated have been proposed as interventions capable of preventing complications during non-elective intubation and are used intermittently in routine care -- however neither have been examined in a prospective trial.
The investigators propose a randomized trial comparing use of a written checklist versus no written checklist and ramped versus sniffing position for endotracheal intubation of critically ill adults.
연구 유형
중재적
등록 (실제)
260
단계
- 4단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Alabama
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Birmingham, Alabama, 미국, 35294
- University of Alabama - Birmingham
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Louisiana
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New Orleans, Louisiana, 미국, 70115
- Ochsner Medical Center
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New Orleans, Louisiana, 미국, 70112
- Louisiana State University School of Medicine
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Tennessee
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Nashville, Tennessee, 미국, 37232
- Vanderbilt University
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Washington
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Seattle, Washington, 미국, 98104
- University of Washington
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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
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
Airway management events will be included in which:
- Patient is admitted to the Medical Intensive Care Unit (MICU)
- Planned procedure is endotracheal intubation
- Planned operator is a Pulmonary and Critical Care Medicine (PCCM) fellow
- Administration of sedation and/or neuromuscular blockade is planned
- Age ≥ 18 years old
Exclusion Criteria:
Airway management events will be excluded in which:
- Operator feels specific patient positioning during intubation is required
- Urgency of intubation precludes safe performance of study procedures
- Operator feels an alternative pre-procedure checklist or no checklist is required
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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간섭 없음: Sniffing Position, No Checklist
Patient in the sniffing position without the use of a written checklist
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활성 비교기: Sniffing Position, Checklist
Patient in the sniffing position with the use of a written checklist
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Use of a written checklist pre and peri-intubation
다른 이름들:
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활성 비교기: Head of Bed Up, No Checklist
Patient with the head of bed up and without the use of a checklist
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Raising the patient's head of bed to 25 degrees
다른 이름들:
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활성 비교기: Head of Bed Up, Checklist
Patient with the head of bed up and with the use of a checklist
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Use of a written checklist pre and peri-intubation
다른 이름들:
Raising the patient's head of bed to 25 degrees
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Lowest Arterial Oxygen Saturation (Both positioning and Checklist interventions)
기간: Time of Induction through 2 minutes after successful intubation
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Lowest non-invasively measured arterial oxygen saturation between the time of induction or neuromuscular blockade and two minutes after completion of the airway management procedure
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Time of Induction through 2 minutes after successful intubation
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Lowest Systolic Blood Pressure (Checklist intervention only)
기간: Time of Induction through 2 minutes after successful intubation
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Lowest non-invasively or invasively measured systolic blood pressure between medication administration and 2 minutes following successful placement of an endotracheal tube (in checklist comparison only)
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Time of Induction through 2 minutes after successful intubation
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence of Desaturation
기간: Time of Induction through 2 minutes after successful intubation
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Decrease in oxygen saturation of greater than 3% from induction to lowest oxygen saturation
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Time of Induction through 2 minutes after successful intubation
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Incidence of Hypoxemia
기간: Time of Induction through 2 minutes after successful intubation
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Defined by lowest oxygen saturation less than 90% and severe hypoxemia as defined by lowest oxygen saturation less than 80%
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Time of Induction through 2 minutes after successful intubation
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Change in Saturation
기간: Time of Induction through 2 minutes after successful intubation
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Change in oxygen saturation from baseline to lowest oxygen saturation
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Time of Induction through 2 minutes after successful intubation
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Grade of First Glottic View
기간: Time of Induction through 2 minutes after successful intubation
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Cormack-Lehane grade of view on first intubation attempt
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Time of Induction through 2 minutes after successful intubation
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First Pass Success
기간: Time of Induction through 2 minutes after successful intubation
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Placement of an endotracheal tube in the trachea after the first insertion of the laryngoscope into the oral cavity without the use of any other devices
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Time of Induction through 2 minutes after successful intubation
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Number of Intubation Attempts
기간: Time of Induction through 2 minutes after successful intubation
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Number of attempts required for successful tube placement
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Time of Induction through 2 minutes after successful intubation
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Time to Intubation
기간: Time of Induction through 2 minutes after successful intubation
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Time (in minutes) from pushing of induction meds to successful placement of endotracheal tube
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Time of Induction through 2 minutes after successful intubation
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Need for Assistance
기간: Time of Induction through 2 minutes after successful intubation
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Incidence of need for additional intubating equipment, second operator
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Time of Induction through 2 minutes after successful intubation
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Non-hypoxic complications
기간: Time of Induction through 2 minutes after successful intubation
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Incidence of non-oxygenation complications - composite of all other recorded complications
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Time of Induction through 2 minutes after successful intubation
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Malposition of Endotracheal Tube
기간: Time of Induction through 2 minutes after successful intubation
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Incidence of post-intubation tube malposition on Chest X-Ray (CXR)
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Time of Induction through 2 minutes after successful intubation
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Repositioning Patient
기간: Time of Induction through 2 minutes after successful intubation
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Incidence of repositioning patient after procedure initiation
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Time of Induction through 2 minutes after successful intubation
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In-Hospital Mortality
기간: From enrollment through the earlier of hospital discharge or 365 days
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Death before hospital discharge
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From enrollment through the earlier of hospital discharge or 365 days
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Ventilator-free Days
기간: From enrollment through study day 28
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Days alive and free from mechanical ventilation
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From enrollment through study day 28
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ICU-Free Days
기간: From enrollment through study day 28
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Days alive and out of the ICU
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From enrollment through study day 28
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 책임자: Todd W Rice, MD, MSc, Vanderbilt University Medical Center
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Janz DR, Semler MW, Joffe AM, Casey JD, Lentz RJ, deBoisblanc BP, Khan YA, Santanilla JI, Bentov I, Rice TW; Check-UP Investigators*; Pragmatic Critical Care Research Group. A Multicenter Randomized Trial of a Checklist for Endotracheal Intubation of Critically Ill Adults. Chest. 2018 Apr;153(4):816-824. doi: 10.1016/j.chest.2017.08.1163. Epub 2017 Sep 14.
- Semler MW, Janz DR, Russell DW, Casey JD, Lentz RJ, Zouk AN, deBoisblanc BP, Santanilla JI, Khan YA, Joffe AM, Stigler WS, Rice TW; Check-UP Investigators( *); Pragmatic Critical Care Research Group. A Multicenter, Randomized Trial of Ramped Position vs Sniffing Position During Endotracheal Intubation of Critically Ill Adults. Chest. 2017 Oct;152(4):712-722. doi: 10.1016/j.chest.2017.03.061. Epub 2017 May 6.
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
2015년 7월 1일
기본 완료 (실제)
2016년 9월 1일
연구 완료 (실제)
2016년 9월 1일
연구 등록 날짜
최초 제출
2015년 7월 6일
QC 기준을 충족하는 최초 제출
2015년 7월 10일
처음 게시됨 (추정)
2015년 7월 14일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2016년 9월 19일
QC 기준을 충족하는 마지막 업데이트 제출
2016년 9월 16일
마지막으로 확인됨
2016년 9월 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. .