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NCT Number: NCT07306325

Ultrasound in Predicting Difficult Intubation in Acromegaly Patients

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • • 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

Exclusion criteria

  • 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.

Treatment and study plan

observational study

Other

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.

Primary outcomes

  1. Airway Ultrasonography

    Time frame: one year

    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):

  2. Airway Ultrasonography

    Time frame: one year

    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):

  3. Airway Ultrasonography

    Time frame: one year

    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)

Secondary outcomes

  1. preoperative physical examination

    Time frame: one year

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

    -Age(year)

  2. preoperative physical examination

    Time frame: one year

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

    -Gender:

  3. preoperative physical examination

    Time frame: one year

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

  4. preoperative physical examination

    Time frame: one year

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

    • weight(kilograms)
  5. preoperative physical examination

    Time frame: one year

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

    • BMI(kg/m^2):
  6. preoperative physical examination

    Time frame: one year

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

  7. preoperative physical examination

    Time frame: one year

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

  8. preoperative physical examination

    Time frame: one year

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

  9. preoperative physical examination

    Time frame: one year

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

  10. correlation with laboratory

    Time frame: one year

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

  11. correlation with laboratory

    Time frame: one year

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

Study contacts

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

Muzaffer Gencer

CONTACT

[email protected]

00905059436459

Rabia Genç

CONTACT

[email protected]

00905359831528

Sponsors and collaborators

Lead sponsor

Başakşehir Çam & Sakura City Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 29, 2025
Registry last updated
Dec 29, 2025

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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