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Not yet recruitingNCT07659912ACRO-VLUpdated Jun 22, 2026

Direct Versus Video Laryngoscopy in Patients With Acromegaly

An observational study in Acromegaly and Nonfunctioning Pituitary Adenoma, sponsored by Muzaffer GENCER. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-22.

Sponsored by Muzaffer GENCER · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • 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
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In context

Acromegaly

202 studies on the registry are indexed under Acromegaly; 19 are open to participants now.

This study's planned enrollment of 40 is below the median of 100 across 81 observational studies indexed under Acromegaly.

Browse Acromegaly studies →

Lead sponsor

Muzaffer GENCER is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study 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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria

Exclusion Criteria:

  • Age younger than 18 years
  • Refusal to participate in the study
  • Presence of extrapituitary
  • 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (estimated)
Patient registry
No

Groups and cohorts

  • Acromegaly Group

    Adult patients diagnosed with acromegaly who are scheduled for elective surgery under general anesthesia requiring endotracheal intubation.

  • Nonfunctioning Pituitary Adenoma Group

    Adult patients diagnosed with nonfunctioning pituitary adenoma who are scheduled for elective surgery under general anesthesia requiring endotracheal intubation.

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What researchers measure

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 procedure

Secondary 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 anesthesia

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 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. PubMed 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. PubMed 28620866 ↗

Individual participant data

Plan to share: No — Individual participant data will not be shared. Only aggregated and anonymized study results may be presented in scientific meetings or published in peer-reviewed journals.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07659912
Lead sponsor
Muzaffer GENCER
Responsible party
Muzaffer GENCER (Anesthesiologist, Başakşehir Çam & Sakura City Hospital) — Sponsor-investigator
First posted
Jun 22, 2026
Start date
Jul 1, 2026 (estimated)
Primary completion
Aug 31, 2026 (estimated)
Completion
Aug 31, 2026 (estimated)
Last update
Jun 22, 2026

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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