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Direct Versus Video Laryngoscopy in Patients With Acromegaly

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07659912
Acronym
ACRO-VL
Enrollment
40
Registered
2026-06-22
Start date
2026-07-01
Completion date
2026-08-31
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acromegaly, Nonfunctioning Pituitary Adenoma

Keywords

Acromegaly, Difficult Intubation, Direct Laryngoscopy, Video Laryngoscopy, Cormack-Lehane Classification, Airway Management, Growth Hormone, Insulin-Like Growth Factor 1, Pituitary Adenoma

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

Muzaffer GENCER
Lead SponsorOTHER_GOV
Başakşehir Çam & Sakura City Hospital
CollaboratorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Modified Cormack-Lehane Grade With Direct and Video LaryngoscopyDuring tracheal intubation procedureThe 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.

Secondary

MeasureTime frameDescription
Mallampati Classification ScorePreoperative airway assessment before induction of anesthesiaThe 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 to Successful IntubationDuring tracheal intubation procedureTime 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.
Number of Intubation AttemptsDuring tracheal intubation procedureThe 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.
Need for Adjunct Airway Maneuvers or DevicesFrom induction of anesthesia until confirmation of successful endotracheal tube placement by capnography during the airway management procedureThe 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.
Peri-Intubation Oxygen DesaturationFrom anesthesia induction to 5 minutes after intubationPeri-intubation oxygen desaturation will be defined as a decrease in peripheral oxygen saturation below 90% during airway management.
Airway TraumaImmediately after intubationAirway trauma will be assessed by the presence of mucosal bleeding, dental trauma, lip injury, or other visible airway-related injury after intubation.
Association Between Growth Hormone Level and Difficult LaryngoscopyBaseline preoperative assessment and during the tracheal intubation procedurePreoperative 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.
Association Between Insulin-Like Growth Factor 1 Level and Difficult LaryngoscopyPreoperative baseline assessment and during the tracheal intubation procedurePreoperative 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.

Contacts

CONTACTMuzaffer Gencer, associate professor
dr.m.gencer07@gmail.com+90 212 909 60 00

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 23, 2026