Direct Versus Video Laryngoscopy in Patients With Acromegaly

Официальное название

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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Modified Cormack-Lehane Grade With Direct and Video Laryngoscopy [Срок оценки: During tracheal intubation procedure]

Вторичные конечные точки (8)

• Mallampati Classification Score [Срок оценки: Preoperative airway assessment before induction of anesthesia]
• Time to Successful Intubation [Срок оценки: During tracheal intubation procedure]
• Number of Intubation Attempts [Срок оценки: During tracheal intubation procedure]
• Need for Adjunct Airway Maneuvers or Devices [Срок оценки: From induction of anesthesia until confirmation of successful endotracheal tube placement by capnography during the airway management procedure]
• Peri-Intubation Oxygen Desaturation [Срок оценки: From anesthesia induction to 5 minutes after intubation]
• Airway Trauma [Срок оценки: Immediately after intubation]
• Association Between Growth Hormone Level and Difficult Laryngoscopy [Срок оценки: Baseline preoperative assessment and during the tracheal intubation procedure]
• Association Between Insulin-Like Growth Factor 1 Level and Difficult Laryngoscopy [Срок оценки: Preoperative baseline assessment and during the tracheal intubation procedure]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Friedel ME, Johnston DR, Singhal S, Al Khalili K, Farrell CJ, Evans JJ, Nyquist GG, Rosen MR. Airway management and perioperative concerns in acromegaly patients undergoing endoscopic transsphenoidal surgery for pituitary tumors. Otolaryngol Head Neck Surg. 2013 Dec;149(6):840-4. doi: 10.1177/0194599813507236. Epub 2013 Oct 3. PMID 24091425
• Ali Z, Bithal PK, Prabhakar H, Rath GP, Dash HH. An assessment of the predictors of difficult intubation in patients with acromegaly. J Clin Neurosci. 2009 Aug;16(8):1043-5. doi: 10.1016/j.jocn.2008.11.002. Epub 2009 May 19. PMID 19457671
• Zhang Y, Guo X, Pei L, Zhang Z, Tan G, Xing B. High levels of IGF-1 predict difficult intubation of patients with acromegaly. Endocrine. 2017 Aug;57(2):326-334. doi: 10.1007/s12020-017-1338-x. Epub 2017 Jun 15. PMID 28620866

Идентификаторы

NCT: NCT07659912 · ACRO-VL-2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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