Direct Versus Video Laryngoscopy in Patients With Acromegaly

N/ANot Yet RecruitingNCT07659912

Muzaffer GENCER40 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Modified Cormack-Lehane Grade With Direct and Video Laryngoscopy

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.

Time frame: During tracheal intubation procedure

Secondary Outcomes

Mallampati Classification Score

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.

Time frame: Preoperative airway assessment before induction of anesthesia

Time to Successful Intubation

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.

Time frame: During tracheal intubation procedure

Number of Intubation Attempts

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.

Time frame: During tracheal intubation procedure

Need for Adjunct Airway Maneuvers or Devices

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.

Time frame: From induction of anesthesia until confirmation of successful endotracheal tube placement by capnography during the airway management procedure

Peri-Intubation Oxygen Desaturation

Peri-intubation oxygen desaturation will be defined as a decrease in peripheral oxygen saturation below 90% during airway management.

Time frame: From anesthesia induction to 5 minutes after intubation

Airway Trauma

Airway trauma will be assessed by the presence of mucosal bleeding, dental trauma, lip injury, or other visible airway-related injury after intubation.

Time frame: Immediately after intubation

Association Between Growth Hormone Level and Difficult Laryngoscopy

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.

Time frame: Baseline preoperative assessment and during the tracheal intubation procedure

Association Between Insulin-Like Growth Factor 1 Level and Difficult Laryngoscopy

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.

Time frame: Preoperative baseline assessment and during the tracheal intubation procedure

Direct Versus Video Laryngoscopy in Patients With Acromegaly

Overview

Conditions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts