Direct Versus Video Laryngoscopy in Patients With Acromegaly
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMuzaffer GENCER
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Age younger than 18 years
Refusal to participate in the study
Presence of extrapituitary malignancy
Emergency surgery
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
40 Participants
are grouped into 2 trial groupsGroup A: Acromegaly Group
Group B: Nonfunctioning Pituitary Adenoma Group
Trial outcomes
Primary outcomes
1
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 procedureSecondary outcomes
1
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 anesthesia2
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 procedure3
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 procedure4
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 procedureLocations
Sponsors and contacts
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Muzaffer GENCER
Lead sponsor
Başakşehir Çam & Sakura City Hospital
Sponsor institution
Başakşehir Çam & Sakura City Hospital
Collaborator
Source ClinicalTrials.gov
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