Preventing Hypoxemia With Manual Ventilation During Endotracheal Intubation (PreVent) Trial (PreVent)
2018년 9월 12일 업데이트: Matthew Semler, Vanderbilt University Medical Center
Complications are common during endotracheal intubation of critically ill adults.
Manual ventilation between induction and intubation ("bag-valve-mask" ventilation) has been proposed as a means of preventing hypoxemia, the most common complication of intubation outside the operating room.
Safety and efficacy data, however, are lacking.
PreVent is a randomized trial comparing manual ventilation between induction and laryngoscopy to no manual ventilation between induction an laryngoscopy during endotracheal intubation of critically ill adults.
The primary efficacy endpoint will be the lowest arterial oxygen saturation.
The primary safety endpoints will be the lowest oxygen saturation, highest fraction of inspired oxygen, and highest positive end-expiratory pressure in the 24 hours after the procedure.
연구 개요
상세 설명
PreVent is a prospective, parallel-group, pragmatic, randomized trial comparing manual ventilation between induction and laryngoscopy to no manual ventilation between induction an laryngoscopy during endotracheal intubation of critically ill adults.
The primary aim of the PreVent trial is to compare the effect of manual ventilation between induction and intubation versus no manual ventilation on the lowest arterial oxygen saturation experienced by critically ill adults undergoing endotracheal intubation.
The PreVent trial is anticipated to begin enrollment in January 2017 and will enroll adults undergoing endotracheal intubation with sedation and/or neuromuscular blockade in participating units.
Patients will be randomized 1:1 to manual ventilation versus no manual ventilation.
In the manual ventilation group, manual ventilation using a bag-valve-mask will be provided from the time of induction until the time of endotracheal intubation, except during laryngoscopy.
In the no manual ventilation group, no manual ventilation will be provided between induction and endotracheal intubation, except for the treatment of hypoxemia.
The primary efficacy endpoint will be the lowest arterial oxygen saturation during the procedure.
The primary safety endpoints will be the lowest oxygen saturation, highest fraction of inspired oxygen, and highest positive end expiratory pressure in the 24 hours after intubation.
Conduct of the trial will be overseen by a Data Safety Monitoring Board.
An interim analysis will be performed after the enrollment of 175 patients.
The analysis of the trial will be conducted in accordance with a pre-specified statistical analysis plan made publicly available prior to the conclusion of enrollment.
The initial planned enrollment of 350 patients was increased by the Data and Safety Monitoring Board at the interim analysis to a final planned enrollment of 400 patients.
연구 유형
중재적
등록 (실제)
401
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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Alabama
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Birmingham, Alabama, 미국, 35294
- The University of Alabama at Birmingham
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Louisiana
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New Orleans, Louisiana, 미국, 70121
- Ochsner Health System
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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, 37209
- Vanderbilt University Medical Center
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Washington
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Seattle, Washington, 미국, 98104
- Harborview Medical Center, 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:
- Patient is located in a participating unit
- Planned procedure is endotracheal intubation
- Planned operator is a provider expected to routinely perform endotracheal intubation in the participating unit
- Administration of sedation and/or neuromuscular blockade is planned
- Age ≥ 18 years old
Exclusion Criteria:
- Urgency of intubation precludes safe performance of study procedures
- Operator feels a specific approach to ventilation between induction and intubation is required
- Pregnant women
- Prisoners
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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활성 비교기: Manual Ventilation
Beginning after the administration of sedation/neuromuscular blockade, manual ventilation will be provided by bag-valve-mask until the initiation of laryngoscopy.
In patients requiring more than one attempt at laryngoscopy, bag-valve-mask ventilation will resume between laryngoscopy attempts.
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Beginning after the administration of sedation/neuromuscular blockade, manual ventilation will be provided by bag-valve-mask until the initiation of laryngoscopy.
In patients requiring more than one attempt at laryngoscopy, bag-valve-mask ventilation will resume between laryngoscopy attempts.
다른 이름들:
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활성 비교기: No Manual Ventilation
Between the administration of sedation/neuromuscular blockade and intubation, ventilation will not be provided unless the patient experiences an arterial oxygen saturation less than 90%.
For patients who experience an oxygen saturation less than 90% after induction, bag-valve-mask ventilation may be provided.
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Between the administration of sedation/neuromuscular blockade and intubation, ventilation will not be provided unless the patient experiences an arterial oxygen saturation less than 90%.
For patients who experience an oxygen saturation less than 90% after induction, bag-valve-mask ventilation may be provided.
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
기간: Induction to 2 minutes after completion of the airway management procedure
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The lowest arterial oxygen saturation measured by continuous pulse oximetry (SpO2) between induction and 2 minutes after completion of the airway management procedure.
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Induction to 2 minutes after completion of the airway management procedure
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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병원 내 사망률
기간: 28일
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28일
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Incidence of lowest oxygen saturation less than 90%
기간: Induction to 2 minutes after completion of the airway management procedure
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Incidence of lowest oxygen saturation less than 90% in the time from induction to 2 minutes after completion of the airway management procedure.
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Induction to 2 minutes after completion of the airway management procedure
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Incidence of lowest oxygen saturation less than 80%
기간: Induction to 2 minutes after completion of the airway management procedure
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Incidence of lowest oxygen saturation less than 80% in the time from induction to 2 minutes after completion of the airway management procedure.
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Induction to 2 minutes after completion of the airway management procedure
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Change in saturation from induction to lowest oxygen saturation
기간: Induction to 2 minutes after completion of the airway management procedure
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Change in saturation from induction to lowest oxygen saturation within 2 minutes after completion of the airway management procedure.
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Induction to 2 minutes after completion of the airway management procedure
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Incidence of desaturation
기간: Induction to 2 minutes after completion of the airway management procedure
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Incidence of desaturation as defined by a decrease in oxygen saturation of greater than 3% from induction to lowest oxygen saturation within 2 minutes after completion of the airway management procedure.
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Induction to 2 minutes after completion of the airway management procedure
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Lowest oxygen saturation in the 24 hours after intubation.
기간: 24 hours after intubation
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24 hours after intubation
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Highest fraction of inspired oxygen in the 24 hours after intubation.
기간: 24 hours after intubation
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24 hours after intubation
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Highest positive end expiratory pressure in the 24 hours after intubation.
기간: 24 hours after intubation
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24 hours after intubation
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Lowest oxygen saturation, highest fraction of inspired oxygen, and highest positive end expiratory pressure from 0-1, 1-6, and 6- 24 hours after intubation.
기간: 24 hours after intubation
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Lowest oxygen saturation, highest fraction of inspired oxygen, and highest positive end expiratory pressure from 0-1, 1-6, and 6- 24 hours after intubation.
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24 hours after intubation
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Operator-reported pulmonary aspiration
기간: Induction to 2 minutes after completion of the airway management procedure
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Visualization of oropharyngeal or gastric contents in the pharynx, larynx, or trachea between induction and completion of airway management.
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Induction to 2 minutes after completion of the airway management procedure
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New infiltrate on chest imaging in the 48 hours after intubation
기간: 48 hours after intubation
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Determination of new infiltrate will be made by two blinded experts (pulmonary/critical care attendings or fellows) with adjudication by a third expert in the case of discordant results
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48 hours after intubation
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Operator-reported pulmonary aspiration, new chest x-ray infiltrate, OR lowest oxygen saturation < 80% (composite outcome)
기간: 48 hours after intubation
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48 hours after intubation
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New pneumothorax or pneumomediastinum on chest imaging in the 24 hours after intubation
기간: 24 hours after intubation
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24 hours after intubation
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Incidence of esophageal intubation
기간: Induction to 2 minutes after completion of the airway management procedure
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Induction to 2 minutes after completion of the airway management procedure
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Lowest systolic blood pressure (peri-procedural)
기간: Induction to 2 minutes after completion of the airway management procedure
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Lowest systolic blood pressure between induction and two minutes after completion of the airway management procedure
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Induction to 2 minutes after completion of the airway management procedure
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New systolic blood pressure < 65 mmHg or new need for vasopressor
기간: Induction to 2 minutes after completion of the airway management procedure
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New systolic blood pressure < 65 mmHg or new need for vasopressor between medication administration and 2 minutes following successful placement of an endotracheal tube
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Induction to 2 minutes after completion of the airway management procedure
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Cardiac arrest within one hour of intubation
기간: One hour after intubation.
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One hour after intubation.
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Death within one hour of intubation
기간: One hour after intubation
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One hour after intubation
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Cormack-Lehane grade of glottic view
기간: Induction to 2 minutes after completion of the airway management procedure
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Induction to 2 minutes after completion of the airway management procedure
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Operator-assessed difficulty of intubation
기간: Induction to 2 minutes after completion of the airway management procedure
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Induction to 2 minutes after completion of the airway management procedure
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Incidence of successful intubation on the first laryngoscopy attempt
기간: Induction to 2 minutes after completion of the airway management procedure
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Induction to 2 minutes after completion of the airway management procedure
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Number of laryngoscopy attempts
기간: Induction to 2 minutes after completion of the airway management procedure
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Induction to 2 minutes after completion of the airway management procedure
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Time from induction to successful intubation
기간: Induction to 2 minutes after completion of the airway management procedure
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Induction to 2 minutes after completion of the airway management procedure
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Need for additional airway equipment or a second operator
기간: Induction to 2 minutes after completion of the airway management procedure
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Induction to 2 minutes after completion of the airway management procedure
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Ventilator-free days
기간: 28 days
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Ventilator-free days to day 28 will be defined as the number of days alive and with unassisted breathing to day 28 after enrollment, assuming a patient survives for at least two consecutive calendar days after initiating unassisted breathing and remains free of assisted breathing.
If a patient returns to assisted breathing and subsequently achieves unassisted breathing prior to day 28, VFD will be counted from the end of the last period of assisted breathing to day 28.
If the patient is receiving assisted ventilation at day 28 or dies prior to day 28, VFD will be 0. If a patient is discharged while receiving assisted ventilation, VFD will be 0. All data will be censored at the first of hospital discharge or 28 days.
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28 days
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Intensive care unit-free days
기간: 28 days
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ICU-free days to 28 days after enrollment will be defined as the number of days alive and not admitted to an intensive care unit service after the patient's final discharge from the intensive care unit in that hospitalization before 28 days.
Patients who are never discharged from the intensive care unit will receive a value of 0. Patients who die before day 28 will receive a value of 0. For patients who return to an ICU and are subsequently discharged prior to day 28, ICU-free days will be counted from the date of final ICU discharge.
All data will be censored at the first of hospital discharge or 28 days.
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28 days
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: 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
- Casey JD, Janz DR, Russell DW, Vonderhaar DJ, Joffe AM, Dischert KM, Brown RM, Zouk AN, Gulati S, Heideman BE, Lester MG, Toporek AH, Bentov I, Self WH, Rice TW, Semler MW; PreVent Investigators and the Pragmatic Critical Care Research Group. Bag-Mask Ventilation during Tracheal Intubation of Critically Ill Adults. N Engl J Med. 2019 Feb 28;380(9):811-821. doi: 10.1056/NEJMoa1812405. Epub 2019 Feb 18.
- Casey JD, Janz DR, Russell DW, Vonderhaar DJ, Joffe AM, Dischert KM, Brown RM, Lester MG, Zouk AN, Gulati S, Stigler WS, Rice TW, Semler MW; PreVent Investigators and the Pragmatic Critical Care Research Group. Manual ventilation to prevent hypoxaemia during endotracheal intubation of critically ill adults: protocol and statistical analysis plan for a multicentre randomised trial. BMJ Open. 2018 Aug 10;8(8):e022139. doi: 10.1136/bmjopen-2018-022139.
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 (실제)
2017년 3월 15일
기본 완료 (실제)
2018년 5월 6일
연구 완료 (실제)
2018년 7월 6일
연구 등록 날짜
최초 제출
2017년 1월 16일
QC 기준을 충족하는 최초 제출
2017년 1월 19일
처음 게시됨 (추정)
2017년 1월 20일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 9월 13일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 9월 12일
마지막으로 확인됨
2018년 9월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- IRB #161962
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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. .
기관내삽관에 대한 임상 시험
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Rady Children's Hospital, San Diego종료됨
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Second Military Medical University완전한Transillumination-guided Fiberoptic Intubation 삽관법중국
Manual Ventilation에 대한 임상 시험
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Istanbul Medeniyet University모병
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