An observational study in Acromegaly Due to Pituitary Adenoma, Difficult Intubation and Airway Ultrasonography, sponsored by Başakşehir Çam & Sakura City Hospital. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-12-29.
Sponsored by Başakşehir Çam & Sakura City Hospital · Observational
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.
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.
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.
Patients diagnosed with acromegaly who are planned for endoscopic pituitary surgery
Exclusion Criteria:
ASA 4 patient group
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
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.
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):
Time frame: 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):
Time frame: 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)
Time frame: one year
preoperative physical examination
Prediction of difficult intubation in participants diagnosed with acromegaly using classical airway examination tests -Age(year)
Time frame: one year
preoperative physical examination
Prediction of difficult intubation in participants diagnosed with acromegaly using classical airway examination tests -Gender:
Time frame: one year
preoperative physical examination
Prediction of difficult intubation in participants diagnosed with acromegaly using classical airway examination tests -Height(centimeters)
Time frame: one year
preoperative physical examination
Prediction of difficult intubation in participants diagnosed with acromegaly using classical airway examination tests * weight(kilograms)
Time frame: one year
preoperative physical examination
Prediction of difficult intubation in participants diagnosed with acromegaly using classical airway examination tests * BMI(kg/m\^2):
Time frame: one year
preoperative physical examination
Prediction of difficult intubation in participants diagnosed with acromegaly using classical airway examination tests -Thyromental Distance(centimeters)
Time frame: one year
preoperative physical examination
Prediction of difficult intubation in participants diagnosed with acromegaly using classical airway examination tests -Stenomental Distance(centimeters) :
Time frame: one year
preoperative physical examination
Prediction of difficult intubation in participants diagnosed with acromegaly using classical airway examination tests - Upper Lip Biting Test:
Time frame: one year
preoperative physical examination
Prediction of difficult intubation in participants diagnosed with acromegaly using classical airway examination tests - Mallampati Score:
Time frame: one year
correlation with laboratory
Does difficult intubation become more frequent as growth hormone levels (nanograms/milliliter) increase?
Time frame: one year
correlation with laboratory
Does difficult intubation become more frequent as insulin-like growth hormone- 1 levels (micrograms/liter) increase?
Time frame: one year
This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Growth Hormone-Secreting Pituitary Adenoma
Başakşehir Çam & Sakura City Hospital