Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use (MEASURE-ILD)
Development of an Intelligent Video Laryngoscope and Preliminary Verification for Emergency Application
The investigators are developing a video laryngoscope equipped with artificial intelligence technology to enable automatic identification of key airway anatomical structures and real-time guidance during intubation, with the aim of improving the success rate and efficiency of endotracheal intubation in emergency settings.
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Jintao Wei wei
- 전화번호: 19560480512
- 이메일: weijintao@zju.edu.cn
연구 장소
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Zhejiang
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Hangzhou, Zhejiang, 중국
- 모병
- Second Affiliated Hospital, Zhejiang University, School of Medicine
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연락하다:
- Jintao Wei
- 전화번호: +86 19560480512
- 이메일: weijintao@zju.edu.cn
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Shaoxing, Zhejiang, 중국, 312000
- 모병
- Shaoxing Central Hospital
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연락하다:
- dongzhi liu
- 이메일: weijintao@zju.edu.cn
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patient inclusion criteria: Adult patients in critical condition requiring endotracheal intubation via laryngoscopy (age ≥ 18 years).
Exclusion Criteria:
- pregnant women, prisoners, recent history of airway surgery, oral or pharyngeal malformations, inability to perform randomization due to the need for emergency endotracheal intubation, or when the investigator deemed it necessary or contraindicated to use AIVL, VL, or DL during the first intubation attempt.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Video Laryngoscope(VL)
Participants randomized to this arm (n=60) will undergo the first endotracheal intubation attempt using a conventional video laryngoscope (VL), without AI-assisted anatomical identification or intubation guidance. |
A conventional video laryngoscope will be used for the first endotracheal intubation attempt. The device displays the airway image without AI-assisted identification of anatomical structures or real-time AI intubation guidance. |
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실험적: AI-assisted Video Laryngoscope (AIVL)
Participants randomized to this arm (n=60) will undergo the first endotracheal intubation attempt using an AI-assisted video laryngoscope (AIVL), which provides real-time identification of airway anatomical structures and intubation guidance. Operators will receive standardized training on the device controls, guidance interface, and image display before use. Operators may decide whether to follow the AI guidance. |
When using the AIVL for the first attempt at laryngoscopy intubation, the operator shall receive pre-procedural training, which primarily covers the functional buttons, the prompt interface, and image display. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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First-pass intubation success rate
기간: The time from enrollment to completion of intubation (usually within 10 minutes).
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Proportion of participants with successful endotracheal tube placement on the first laryngoscopic attempt, confirmed by end-tidal carbon dioxide monitoring. |
The time from enrollment to completion of intubation (usually within 10 minutes).
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Intubation time
기간: The time from enrollment to completion of intubation (usually within 10 minutes).
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Time in seconds from insertion of the laryngoscope into the oral cavity until the endotracheal tube passes through the glottis. |
The time from enrollment to completion of intubation (usually within 10 minutes).
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Severe complications occurring within 2 minutes after intubation were defined as severe hypoxemia (peripheral SpO₂ <80%), severe hypotension (systolic blood pressure <65 mmHg), initiation of vasoactive agents, cardiac arrest, or death.
기간: From enrollment to the 2 minutes after intubation
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From enrollment to the 2 minutes after intubation
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AI recall
기간: The time from enrollment to completion of intubation (usually within 10 minutes).
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True-positive anatomical detections divided by true-positive plus false-negative detections, assessed against reference annotations. |
The time from enrollment to completion of intubation (usually within 10 minutes).
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Duration of mechanical ventilation
기간: From enrollment to the end of treatment at 8 weeks
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Duration of mechanical ventilation, measured in days. |
From enrollment to the end of treatment at 8 weeks
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28-day all-cause mortality
기간: From enrollment through day 28.
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Proportion of participants who die from any cause within 28 days after enrollment. |
From enrollment through day 28.
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ICU length of stay
기간: From enrollment through the end of treatment, up to 8 weeks.
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Duration of intensive care unit stay, measured in days. |
From enrollment through the end of treatment, up to 8 weeks.
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Total hospital length of stay
기간: From enrollment through the end of treatment, up to 8 weeks.
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Total duration of hospitalization, measured in days. |
From enrollment through the end of treatment, up to 8 weeks.
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AI precision
기간: Video acquired from enrollment to completion of intubation, usually within 10 minutes.
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True-positive anatomical detections divided by true-positive plus false-positive detections, assessed against reference annotations. |
Video acquired from enrollment to completion of intubation, usually within 10 minutes.
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AI specificity
기간: Video acquired from enrollment to completion of intubation, usually within 10 minutes.
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True-negative assessments divided by true-negative plus false-positive assessments, assessed against reference annotations. |
Video acquired from enrollment to completion of intubation, usually within 10 minutes.
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AI F1 score
기간: Video acquired from enrollment to completion of intubation, usually within 10 minutes.
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Harmonic mean of precision and recall: 2 x precision x recall / (precision + recall). |
Video acquired from enrollment to completion of intubation, usually within 10 minutes.
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Mean average precision (mAP)
기간: Video acquired from enrollment to completion of intubation, usually within 10 minutes.
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Mean of average precision across the evaluated anatomical classes against reference annotations. |
Video acquired from enrollment to completion of intubation, usually within 10 minutes.
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
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
키워드
기타 연구 ID 번호
- 2026-0142
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
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