NCT07659912

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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
1mo left

Started Jul 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress52%
Jul 2026Aug 2026

First Submitted

Initial submission to the registry

June 13, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 22, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

June 22, 2026

Status Verified

June 1, 2026

Enrollment Period

2 months

First QC Date

June 13, 2026

Last Update Submit

June 17, 2026

Conditions

Keywords

AcromegalyDifficult IntubationDirect LaryngoscopyVideo LaryngoscopyCormack-Lehane ClassificationAirway ManagementGrowth HormoneInsulin-Like Growth Factor 1Pituitary Adenoma

Outcome Measures

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.

    During tracheal intubation procedure

Secondary Outcomes (8)

  • Mallampati Classification Score

    Preoperative airway assessment before induction of anesthesia

  • Time to Successful Intubation

    During tracheal intubation procedure

  • Number of Intubation Attempts

    During tracheal intubation procedure

  • Need for Adjunct Airway Maneuvers or Devices

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

  • Peri-Intubation Oxygen Desaturation

    From anesthesia induction to 5 minutes after intubation

  • +3 more secondary outcomes

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 24091425BACKGROUND
  • 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.

    PMID: 19457671BACKGROUND
  • 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.

    PMID: 28620866BACKGROUND

MeSH Terms

Conditions

AcromegalyPituitary Neoplasms

Condition Hierarchy (Ancestors)

Bone Diseases, EndocrineBone DiseasesMusculoskeletal DiseasesHyperpituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System DiseasesEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHypothalamic NeoplasmsSupratentorial NeoplasmsBrain NeoplasmsCentral Nervous System NeoplasmsNervous System Neoplasms

Central Study Contacts

Muzaffer Gencer, associate professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Anesthesiologist

Study Record Dates

First Submitted

June 13, 2026

First Posted

June 22, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

June 22, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

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.