NCT07306325

Brief Summary

This is a prospective observational study.The purpose of this study is to predict difficult intubation with ultrasonographic evaluation combined with preoperative physical examination in patients diagnosed with acromegaly and planned for pituitary surgery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

November 24, 2024

Completed
1.1 years until next milestone

Study Start

First participant enrolled

December 25, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 29, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2026

Completed
Last Updated

December 29, 2025

Status Verified

December 1, 2025

Enrollment Period

3 months

First QC Date

November 24, 2024

Last Update Submit

December 13, 2025

Conditions

Keywords

difficult intubationacromegalyairway ultrasonography

Outcome Measures

Primary Outcomes (3)

  • Airway Ultrasonography

    Sonoatomonic evaluation of the airway and determination of difficult intubation in participants diagnosed with acromegaly and planned for pituitary surgery. - Distance Between Skin-Hyoid Bone (centimeters):

    one year

  • Airway Ultrasonography

    Sonoatomonic evaluation of the airway and determination of difficult intubation in participants diagnosed with acromegaly and planned for pituitary surgery. - Distance Between Skin-Epiglottis (centimeters):

    one year

  • Airway Ultrasonography

    Sonoatomonic evaluation of the airway and determination of difficult intubation in participants diagnosed with acromegaly and planned for pituitary surgery. - Distance Between Skin-Vocal Cord Anterior Commissure (centimeters)

    one year

Secondary Outcomes (11)

  • preoperative physical examination

    one year

  • preoperative physical examination

    one year

  • preoperative physical examination

    one year

  • preoperative physical examination

    one year

  • preoperative physical examination

    one year

  • +6 more secondary outcomes

Study Arms (1)

Participants diagnosed with acromegaly

All ultrasonographic assessments will be performed preoperatively by anesthesiologists who have prior experience using ultrasound. Participants will be positioned in the supine position with the head and neck in neutral alignment. Measurements of the skin-hyoid bone, skin-epiglottis, and skin-anterior commissure of the vocal cords distances will be. Endotracheal intubation of the participants will be performed by anesthesiologists who are unfamiliar with the ultrasonographic measurements. During the intubation, the use of adjuncts, the need for cricoid pressure, the number of additional interventions, the number of additional operators, and the glottic opening seen during laryngoscopy will be recorded according to the Cormack-Lehane classification without external pressure. If necessary, advanced airway devices (videolaryngoscopy, flexible fiberoptic laryngoscopy) will be used.

Other: observational study

Interventions

In participants diagnosed with acromegaly, every patient to whom USG measurement methods are applied is followed by researchers before, during and after anesthesia applications, whether or not they are included in any study . Routine treatments that participants need will be fully implemented. Preoperative, intraoperative and postoperative follow-up data, which will be recorded observationally, will be used in this study.

Participants diagnosed with acromegaly

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients between the ages of 18-70, regardless of gender, who are scheduled for endoscopic pituitary surgery at Başakşehir Çam and Sakura City Hospital Neurosurgery Clinic, will be included.

You may qualify if:

  • Patients diagnosed with acromegaly who are planned for endoscopic pituitary surgery
  • Volunteer participants
  • American Society of Anesthesiology - ASA 1, 2 and 3 patient groups
  • Patients with BMI\<40

You may not qualify if:

  • ASA 4 patient group
  • History of previous neck surgery
  • Patients with a history of tracheostomy
  • Patients with a history of radiotherapy to the neck area
  • Patients with limited neck extension (rheumatological - traumatic reasons)
  • Patients with masses and lesions in the mouth and airway that may make intubation difficult.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Başakşehir Çam ve Sakura Hastanesi

Istanbul, Istanbul, 34480, Turkey (Türkiye)

Location

Related Publications (3)

  • Apfelbaum JL, Hagberg CA, Connis RT, Abdelmalak BB, Agarkar M, Dutton RP, Fiadjoe JE, Greif R, Klock PA, Mercier D, Myatra SN, O'Sullivan EP, Rosenblatt WH, Sorbello M, Tung A. 2022 American Society of Anesthesiologists Practice Guidelines for Management of the Difficult Airway. Anesthesiology. 2022 Jan 1;136(1):31-81. doi: 10.1097/ALN.0000000000004002.

    PMID: 34762729BACKGROUND
  • Kasinath MPR, Rastogi A, Priya V, Singh TK, Mishra P, Pant KC. Comparison of Airway Ultrasound Indices and Clinical Assessment for the Prediction of Difficult Laryngoscopy in Elective Surgical Patients: A Prospective Observational Study. Anesth Essays Res. 2021 Jan-Mar;15(1):51-56. doi: 10.4103/aer.aer_75_21. Epub 2021 Aug 30.

    PMID: 34667348BACKGROUND
  • Rao S, Paliwal N, Saharan S, Bihani P, Jaju R, Sharma UD, Sharma M. A Comparative Study to Evaluate Difficult Intubation Using Ratio of Patient Height to Thyromental Distance, Ratio of Neck Circumference to Thyromental Distance and Thyromental Height in Adult Patients in Tertiary Care Centre. Turk J Anaesthesiol Reanim. 2023 Apr;51(2):90-96. doi: 10.5152/TJAR.2022.22077.

    PMID: 37140573BACKGROUND

Related Links

MeSH Terms

Conditions

Growth Hormone-Secreting Pituitary AdenomaAcromegaly

Interventions

Observation

Condition Hierarchy (Ancestors)

AdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsPituitary NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SitePituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System DiseasesBone Diseases, EndocrineBone DiseasesMusculoskeletal DiseasesHyperpituitarism

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Doctor

Study Record Dates

First Submitted

November 24, 2024

First Posted

December 29, 2025

Study Start

December 25, 2025

Primary Completion

March 20, 2026

Study Completion

March 20, 2026

Last Updated

December 29, 2025

Record last verified: 2025-12

Locations