Ultrasound in Predicting Difficult Intubation in Acromegaly Patients

NCT ID: NCT07306325

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

34 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-25

Study Completion Date

2026-03-20

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Acromegaly Due to Pituitary Adenoma Difficult Intubation Airway Ultrasonography

Keywords

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difficult intubation acromegaly airway ultrasonography

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

observational study

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Başakşehir Çam & Sakura City Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Muzaffer GENCER

Associate Professor Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Başakşehir Çam ve Sakura Hastanesi

Istanbul, Istanbul, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Muzaffer Gencer

Role: CONTACT

Phone: 00905059436459

Email: [email protected]

Rabia Genç

Role: CONTACT

Phone: 00905359831528

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 34762729 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34667348 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37140573 (View on PubMed)

Related Links

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Other Identifiers

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BSH-RG-Difficult Intubation

Identifier Type: -

Identifier Source: org_study_id