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Acromegaly Due to Pituitary AdenomaNCT07306325

Ultrasound in Predicting Difficult Intubation in Acromegaly Patients

An observational study of Acromegaly Due to Pituitary Adenoma and Difficult Intubation, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).

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Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
observational study
How many people
34 participants
Where
1 siteTurkey (Türkiye)
Study dates
25 Dec 2025to 20 Mar 2026
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Turkey (Türkiye)1 site
  • Başakşehir Çam ve Sakura Hastanesi

    Istanbul, Istanbul, 34480

Other trials in Turkey (Türkiye)

About this study

Official title: Effectiveness of Ultrasonography in Evaluating the Airway and Predicting Difficult Intubation in Patients Diagnosed With Acromegaly

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.

Read the detailed description

Airway management is an important issue for patient safety in anesthesia. Difficult ventilation and difficult intubation are important causes of anesthesia-related perioperative morbidity and mortality. It is reported that approximately 30% of anesthesia-related mortality is related to inadequacy in difficult airway management. The incidence of difficult intubation is 1.5-13.2% in the general population.

Features evaluated for difficult airway risk prediction: age, gender, body mass index, weight, height, history of difficult intubation, facial and jaw features, mouth opening, head and neck mobility, prominent upper incisors, presence of beard, upper lip bite test, mallampati score, thyromental distance, hyomental distance , sternomental distance includes the distance between the incisors.

Acromegaly is an endocrinological disease with significant mortality and morbidity due to high growth hormone (GH) and insulin-like growth factor-I (IGF-I) levels. It usually occurs due to a pituitary tumor. Excessive GH secretion in adults causes acromegaly with overgrowth in the acral areas. Acral changes seen in these patients may cause abnormal airway structure and, accordingly, airway management may become difficult during anesthesia. Typically, large nose and tongue, thick mandible, and thick and large lips can be observed in acromegaly. There is hypertrophy in the pharynx, larynx, tonsil, vocal cords, mucosa and soft tissues. These features of acromegaly may cause difficult mask ventilation and difficult intubation. The incidence of difficult intubation is observed to be 10%-30% in acromegalic individuals.

With developing technology, the use of ultrasonography in preoperative airway evaluation has become widespread. It is a real-time, non-invasive, easily accessible, mobile, safe, painless method that can be used to evaluate both the upper and lower airway. Clinical airway screening tests aim to predict difficult airways. Recent reviews have shown that ultrasonographic measurements have a greater predictive value than airway screening tests performed by physical examination. Measurements obtained from ultrasound include skin-vocal cord distance, skin-hyoid distance and skin-epiglotte distance.

In the preoperative physical examination; Age, gender, height, weight, body mass index, mouth opening, neck extension, mallampati score, thyromental-hyomental and sternomental distance, neck circumference measurement and upper lip bite test will be evaluated.

All airway ultrasonographic evaluations will be performed preoperatively by experienced anesthesiologists who have previously performed airway ultrasonography. Participants will be prepared for ultrasonographic evaluation in the supine position, and skin-hyoid bone, skin-epiglotte, skin-vocal cord anterior commissure distance measurements will be made and recorded.

Intubation of the participants will be performed by experienced anesthesiologists who are unfamiliar with ultrasonography measurements.The assistive stylet used during the intubation of the participants, the need for cricoid pressure, the number of attempts, the number of practitioners and the glottis opening seen during laryngoscopy will be noted in accordance with the Cormack Lehane classification.Advanced airway devices will be used when necessary.

Preoperative physical examination values, ultrasonographic measurements and blood test results of the participants will be analyzed statistically.

Being tested
observational study
Keywords
difficult intubation, acromegaly, airway ultrasonography
Medical subject headings
Growth Hormone-Secreting Pituitary Adenoma, Acromegaly

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • observational studyOther

    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.

Study groups in NCT07306325
Study groupRoleWhat they receive
Participants diagnosed with acromegalyAll 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.
Receives: Other: observational study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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):

    Measured: one year

  2. 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):

    Measured: one year

  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-Vocal Cord Anterior Commissure (centimeters)

    Measured: one year

Secondary outcomes (11)
  1. preoperative physical examination

    Prediction of difficult intubation in participants diagnosed with acromegaly using classical airway examination tests

    -Age(year)

    Measured: one year

  2. preoperative physical examination

    Prediction of difficult intubation in participants diagnosed with acromegaly using classical airway examination tests

    -Gender:

    Measured: one year

  3. preoperative physical examination

    Prediction of difficult intubation in participants diagnosed with acromegaly using classical airway examination tests -Height(centimeters)

    Measured: one year

  4. preoperative physical examination

    Prediction of difficult intubation in participants diagnosed with acromegaly using classical airway examination tests

    • weight(kilograms)

    Measured: one year

  5. preoperative physical examination

    Prediction of difficult intubation in participants diagnosed with acromegaly using classical airway examination tests

    • BMI(kg/m^2):

    Measured: one year

  6. preoperative physical examination

    Prediction of difficult intubation in participants diagnosed with acromegaly using classical airway examination tests -Thyromental Distance(centimeters)

    Measured: one year

  7. preoperative physical examination

    Prediction of difficult intubation in participants diagnosed with acromegaly using classical airway examination tests -Stenomental Distance(centimeters) :

    Measured: one year

  8. preoperative physical examination

    Prediction of difficult intubation in participants diagnosed with acromegaly using classical airway examination tests - Upper Lip Biting Test:

    Measured: one year

  9. preoperative physical examination

    Prediction of difficult intubation in participants diagnosed with acromegaly using classical airway examination tests - Mallampati Score:

    Measured: one year

  10. correlation with laboratory

    Does difficult intubation become more frequent as growth hormone levels (nanograms/milliliter) increase?

    Measured: one year

  11. correlation with laboratory

    Does difficult intubation become more frequent as insulin-like growth hormone- 1 levels (micrograms/liter) increase?

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2025
  2. Study start25 Dec 2025 (estimated)
  3. Primary completion20 Mar 2026 (estimated)
  4. Study completion20 Mar 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
34 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07306325
Sponsor's protocol ID
BSH-RG-Difficult Intubation
Status last verified
Dec 2025
First submitted
24 Nov 2024
Last updated
29 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 34762729
  • 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.

    PubMed 34667348
  • 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.

    PubMed 37140573

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