Başakşehir Çam ve Sakura Hastanesi
Istanbul, 34480, Turkey (Türkiye)
NCT Number: NCT07306325
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 opening soon.
Get Notified18 year–70 year
All sexes
Observational
Istanbul, 34480, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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):
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):
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)
Time frame: one year
Prediction of difficult intubation in participants diagnosed with acromegaly using classical airway examination tests
-Age(year)
Time frame: one year
Prediction of difficult intubation in participants diagnosed with acromegaly using classical airway examination tests
-Gender:
Time frame: one year
Prediction of difficult intubation in participants diagnosed with acromegaly using classical airway examination tests -Height(centimeters)
Time frame: one year
Prediction of difficult intubation in participants diagnosed with acromegaly using classical airway examination tests
Time frame: one year
Prediction of difficult intubation in participants diagnosed with acromegaly using classical airway examination tests
Time frame: one year
Prediction of difficult intubation in participants diagnosed with acromegaly using classical airway examination tests -Thyromental Distance(centimeters)
Time frame: one year
Prediction of difficult intubation in participants diagnosed with acromegaly using classical airway examination tests -Stenomental Distance(centimeters) :
Time frame: one year
Prediction of difficult intubation in participants diagnosed with acromegaly using classical airway examination tests - Upper Lip Biting Test:
Time frame: one year
Prediction of difficult intubation in participants diagnosed with acromegaly using classical airway examination tests - Mallampati Score:
Time frame: one year
Does difficult intubation become more frequent as growth hormone levels (nanograms/milliliter) increase?
Time frame: one year
Does difficult intubation become more frequent as insulin-like growth hormone- 1 levels (micrograms/liter) increase?
Contact information is provided by the study sponsor or research team.
Muzaffer Gencer
CONTACT
Rabia Genç
CONTACT
Başakşehir Çam & Sakura City Hospital
Other Gov
Effectiveness of Ultrasonography in Evaluating the Airway and Predicting Difficult Intubation in Patients Diagnosed With Acromegaly
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