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

2026年6月17日更新者：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.

研究概览

地位

尚未招聘

条件

详细说明

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.

研究类型

观察性的

注册 (估计的)

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

姓名：Muzaffer Gencer, associate professor
电话号码：+90 212 909 60 00
邮箱：dr.m.gencer07@gmail.com

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

成人
年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

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.

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

团体/队列数

队列和干预

团体/队列
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.

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Modified Cormack-Lehane Grade With Direct and Video Laryngoscopy 大体时间：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

次要结果测量

结果测量	措施说明	大体时间
Mallampati Classification Score 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Muzaffer GENCER

合作者

Başakşehir Çam & Sakura City Hospital

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年7月1日

初级完成 (估计的)

2026年8月31日

研究完成 (估计的)

2026年8月31日

研究注册日期

首次提交

2026年6月13日

首先提交符合 QC 标准的

2026年6月17日

首次发布 (实际的)

2026年6月22日

研究记录更新

最后更新发布 (实际的)