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NCT Number: NCT07659912

Direct Versus Video Laryngoscopy in Patients With Acromegaly

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Modified Cormack-Lehane Grade With Direct and Video Laryngoscopy

    Time frame: 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.

Secondary outcomes

  1. Mallampati Classification Score

    Time frame: 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.

  2. Time to Successful Intubation

    Time frame: 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.

  3. Number of Intubation Attempts

    Time frame: 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.

  4. Need for Adjunct Airway Maneuvers or Devices

    Time frame: 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.

  5. Peri-Intubation Oxygen Desaturation

    Time frame: 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.

  6. Airway Trauma

    Time frame: 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.

  7. Association Between Growth Hormone Level and Difficult Laryngoscopy

    Time frame: 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.

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Muzaffer Gencer, associate professor

CONTACT

[email protected]

+90 212 909 60 00

Sponsors and collaborators

Lead sponsor

Muzaffer GENCER

Other Gov

Collaborators

  • Başakşehir Çam & Sakura City Hospital

Registry information

Official study title

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

Acronym: ACRO-VL

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 22, 2026
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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