- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07590739
Effect Of Left Head Rotation On Glottic View During Video Laryngoscopy In Obese Adults (LeHeR)
Effect of Left Head Rotation Manoeuvre on Glottic View as Assessed With Percentage of Glottic Opening (POGO) Score During Video Laryngoscopy in Obese Adult Patients: A Prospective Observational Study
This study aims to evaluate whether the Left Head Rotation (LeHeR) maneuver improves visualization of the vocal cords during video laryngoscopy in obese adult patients undergoing general anesthesia. Obesity is associated with increased difficulty in airway management due to excess upper airway soft tissue and altered anatomy, which may impair visualization during intubation.
In this prospective observational study, 50 adult patients with a body mass index (BMI) ≥30 kg/m² will undergo video laryngoscopy using a C-MAC D-blade. The glottic view will be assessed using the Percentage of Glottic Opening (POGO) score in the standard sniffing position and after rotating the head 45 degrees to the left (LeHeR maneuver). A difference in POGO score between the two positions will be analyzed.
Secondary outcomes include ease of intubation, number of attempts, time to successful intubation, and occurrence of complications such as desaturation or airway trauma. The study is expected to determine whether the LeHeR maneuver is a simple and effective technique to improve airway visualization in obese patients.
연구 개요
상태
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Kalesh Divakar, MD
- 전화번호: +968 92452839
- 이메일: drkalesh@gmail.com
연구 연락처 백업
- 이름: Harihar V Hegde, MD
- 전화번호: +968 98845606
- 이메일: drharryhegde@yahoo.co.in
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria
- Adult patients aged 18-65 years
- Body mass index (BMI) ≥30 kg/m²
- ASA physical status I-III
- Scheduled for elective surgical procedures under general anesthesia requiring endotracheal intubation
Exclusion Criteria:
- Anticipated need for nasal intubation
- Facial or upper airway pathology preventing laryngoscope insertion
- Cervical spine instability or contraindication to head movement
- Pregnant patients
공부 계획
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디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Percentage of Glottic Opening (POGO) Score between Sniffing Position and Left Head Rotation
기간: Baseline during induction of anaesthesia at the time of video laryngoscopy on Day 1 (single intra-operative assessment)
|
The Percentage of Glottic Opening (POGO) score will be assessed during video laryngoscopy in the sniffing position and after 45-degree left head rotation (LeHeR maneuver).
The difference in POGO score between the two positions will be recorded for each participant.
|
Baseline during induction of anaesthesia at the time of video laryngoscopy on Day 1 (single intra-operative assessment)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Time to Successful Intubation
기간: During induction of anesthesia on Day 1
|
Time taken from insertion of the video laryngoscope blade into the oral cavity until successful placement of the endotracheal tube confirmed by capnography.
|
During induction of anesthesia on Day 1
|
|
Ease of Intubation
기간: During tracheal intubation on Day 1
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Ease of intubation assessed using Fremantle score as easy, modified, or unachievable based on number of attempts and need for adjuncts.
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During tracheal intubation on Day 1
|
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Number of Intubation Attempts
기간: During tracheal intubation on Day 1
|
Number of attempts required to achieve successful tracheal intubation.
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During tracheal intubation on Day 1
|
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Requirement of Airway Adjuncts
기간: During tracheal intubation on Day 1
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Need for additional maneuvers such as external laryngeal manipulation, cuff inflation, or use of Magill forceps during intubation.
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During tracheal intubation on Day 1
|
|
Incidence of Peri-intubation Complications
기간: During induction of anesthesia and tracheal intubation on day 1
|
Occurrence of complications such as oxygen desaturation (SpO₂ <95%) or airway trauma during intubation.
|
During induction of anesthesia and tracheal intubation on day 1
|
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
기타 연구 ID 번호
- MoH/CSR/26/31800
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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