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Direct Versus Video Laryngoscopy in Patients With Acromegaly (ACRO-VL)

2026년 6월 17일 업데이트: Muzaffer GENCER

Determination of the Appropriate Intubation Method in Patients With Acromegaly: Comparison of Direct Laryngoscopy and Video Laryngoscopy

Acromegaly is associated with craniofacial skeletal changes and upper airway soft tissue hypertrophy, which may increase the risk of difficult laryngoscopy and tracheal intubation. This prospective observational study aims to evaluate airway and intubation characteristics in patients with acromegaly undergoing surgery under general anesthesia and to compare direct laryngoscopy and video laryngoscopy findings.

Adult patients with acromegaly and patients with nonfunctioning pituitary adenomas scheduled for surgery under general anesthesia will be prospectively enrolled between July 1, 2026, and August 31, 2026. Preoperative airway assessment parameters, hormonal data including growth hormone and insulin-like growth factor-1 levels, Mallampati score, modified Cormack-Lehane grade, intubation-related variables, and peri-intubation complications will be recorded.

연구 개요

상태

아직 모집하지 않음

정황

상세 설명

This prospective observational study will be conducted at Basaksehir Cam and Sakura City Hospital between July 1, 2026, and August 31, 2026. The study population will include adult patients with acromegaly and adult patients with nonfunctioning pituitary adenomas who are scheduled for elective surgery under general anesthesia requiring endotracheal intubation.

Eligible patients will undergo routine preoperative airway assessment. Recorded variables will include age, sex, height, body weight, body mass index, history of obstructive sleep apnea syndrome, comorbid diseases, previous operations, presence of hypopituitarism, preoperative growth hormone level, preoperative insulin-like growth factor-1 level, IGF-1 index, Mallampati score, and other airway-related clinical parameters.

During airway management, laryngoscopic findings obtained with direct laryngoscopy and video laryngoscopy will be recorded. The modified Cormack-Lehane classification will be used to assess glottic visualization. Intubation-related variables, including first-attempt success, time to successful intubation, number of intubation attempts, need for adjunct airway maneuvers or devices, oxygen desaturation, and airway trauma, will also be documented.

The primary objective of the study is to compare laryngoscopic findings and intubation characteristics in patients with acromegaly and to evaluate whether video laryngoscopy provides advantages over direct laryngoscopy in this patient group. The secondary objective is to identify clinical, hormonal, and airway-related predictors of difficult laryngoscopy or difficult intubation in patients with acromegaly.

연구 유형

관찰

등록 (추정된)

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

이름: Muzaffer Gencer, associate professor
전화번호: +90 212 909 60 00
이메일: dr.m.gencer07@gmail.com

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

성인
고령자

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

비확률 샘플

연구 인구

Adult patients with acromegaly or nonfunctioning pituitary adenoma who are evaluated by the institutional pituitary diseases council and scheduled for elective surgery under general anesthesia requiring endotracheal intubation at Basaksehir Cam and Sakura City Hospital.

설명

Inclusion Criteria:

Age 18 years or older
Diagnosis of acromegaly and scheduled for surgery after evaluation by the institutional pituitary diseases council
Diagnosis of nonfunctioning pituitary adenoma and scheduled for surgery after evaluation by the institutional pituitary diseases council
Requirement for general anesthesia with endotracheal intubation
Ability and willingness to provide written informed consent

Exclusion Criteria:

Age younger than 18 years
Refusal to participate in the study
Presence of extrapituitary malignancy
Emergency surgery
Previous tracheostomy or major laryngeal/tracheal surgery
Severe limitation of mouth opening preventing standard laryngoscopic evaluation
Cervical spine instability or severe restriction of neck extension
Patients requiring awake fiberoptic intubation according to preoperative airway assessment
Patients for whom participation is considered unsafe by the responsible anesthesiologist

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

그룹/코호트 수

코호트 및 개입

그룹/코호트
Acromegaly Group Adult patients diagnosed with acromegaly who are scheduled for elective surgery under general anesthesia requiring endotracheal intubation.
Nonfunctioning Pituitary Adenoma Group Adult patients diagnosed with nonfunctioning pituitary adenoma who are scheduled for elective surgery under general anesthesia requiring endotracheal intubation.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
Modified Cormack-Lehane Grade With Direct and Video Laryngoscopy 기간: During tracheal intubation procedure	The modified Cormack-Lehane grade obtained during direct laryngoscopy and video laryngoscopy will be recorded and compared to evaluate glottic visualization and the degree of laryngoscopic difficulty.	During tracheal intubation procedure

2차 결과 측정

결과 측정	측정값 설명	기간
Mallampati Classification Score 기간: Preoperative airway assessment before induction of anesthesia	The preoperative Mallampati Classification score will be recorded as part of the routine airway assessment and evaluated for its association with difficult laryngoscopy or difficult intubation. The Mallampati Classification ranges from Class I to Class IV, with a minimum value of Class I and a maximum value of Class IV. Higher scores indicate poorer visualization of the oropharyngeal structures and a worse airway assessment, reflecting a greater likelihood of difficult laryngoscopy or difficult intubation.	Preoperative airway assessment before induction of anesthesia
Time to Successful Intubation 기간: During tracheal intubation procedure	Time to successful intubation will be defined as the time, measured in seconds, from insertion of the laryngoscope into the oral cavity to confirmation of endotracheal tube placement by capnography.	During tracheal intubation procedure
Number of Intubation Attempts 기간: During tracheal intubation procedure	The total number of laryngoscopy attempts required for successful endotracheal intubation will be recorded. An intubation attempt will be defined as each insertion of the laryngoscope into the oral cavity with the intention of endotracheal tube placement.	During tracheal intubation procedure
Need for Adjunct Airway Maneuvers or Devices 기간: From induction of anesthesia until confirmation of successful endotracheal tube placement by capnography during the airway management procedure	The need for adjunct airway maneuvers or devices will be recorded as a binary outcome, defined as whether any additional airway maneuver or device is required to achieve successful endotracheal intubation. Adjuncts may include external laryngeal manipulation, stylet, bougie, change of laryngoscope, supraglottic airway device, or fiberoptic bronchoscopy.	From induction of anesthesia until confirmation of successful endotracheal tube placement by capnography during the airway management procedure
Peri-Intubation Oxygen Desaturation 기간: From anesthesia induction to 5 minutes after intubation	Peri-intubation oxygen desaturation will be defined as a decrease in peripheral oxygen saturation below 90% during airway management.	From anesthesia induction to 5 minutes after intubation
Airway Trauma 기간: Immediately after intubation	Airway trauma will be assessed by the presence of mucosal bleeding, dental trauma, lip injury, or other visible airway-related injury after intubation.	Immediately after intubation
Association Between Growth Hormone Level and Difficult Laryngoscopy 기간: Baseline preoperative assessment and during the tracheal intubation procedure	Preoperative growth hormone levels will be recorded and analyzed for their association with the modified Cormack-Lehane grade and difficult laryngoscopy. Difficult laryngoscopy will be assessed during tracheal intubation based on the modified Cormack-Lehane grade.	Baseline preoperative assessment and during the tracheal intubation procedure
Association Between Insulin-Like Growth Factor 1 Level and Difficult Laryngoscopy 기간: Preoperative baseline assessment and during the tracheal intubation procedure	Preoperative insulin-like growth factor 1 levels and insulin-like growth factor 1 index will be recorded and analyzed for their association with the modified Cormack-Lehane grade and difficult laryngoscopy. Difficult laryngoscopy will be assessed during tracheal intubation based on the modified Cormack-Lehane grade.	Preoperative baseline assessment and during the tracheal intubation procedure

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Muzaffer GENCER

협력자

Başakşehir Çam & Sakura City Hospital

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

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 (추정된)

2026년 7월 1일

기본 완료 (추정된)

2026년 8월 31일

연구 완료 (추정된)

2026년 8월 31일

연구 등록 날짜

최초 제출

2026년 6월 13일

QC 기준을 충족하는 최초 제출

2026년 6월 17일

처음 게시됨 (실제)

2026년 6월 22일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)