Clinical trial NCT03578601: Predictive Parameters for Difficult Tracheal Intubation Identification in Thyroid Surgery
Official title: Predictive Parameters for Difficult Tracheal Intubation Identification in Thyroid Surgery, a Observational Monocentric Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intubation;Difficult
Keywords: Intubation
Difficult
thyroid
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2018-07-06
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergoing thyroid surgery

Brief summary: Intubation manoeuvres in patients undergoing thyroid surgery might be challenging for anesthesiologist. Thyroid gland enlargement (goiter) or tissue fibrosis (neoplasms) could alter the physiologic anatomy of upper airways and trachea, resulting in compression or dislocation. We want to evaluate the incidence and identify predictive parameters of difficult intubation in patients undergoing thyroid surgery.

Detailed description: Intubation manoeuvres in patients undergoing thyroid surgery might be challenging for anesthesiologist. Thyroid gland enlargement (goiter) or tissue fibrosis (neoplasms) could alter the physiologic anatomy of upper airways and trachea, resulting in compression or dislocation.

There are few scientific data about airway management and thyroid pathology and the incidence of difficult tracheal intubation in this specific kind of patient is largely variable from 0% to 12.9%. These data have been collected from little statistical samples (from 50 to 326 patients), the results aren't always unanimous and a study evaluating simultaneously all the risk factors for difficult intubation does not exist.

We want to evaluate the incidence and identify predictive parameters of difficult intubation in patients undergoing thyroid surgery.

During pre-anesthetic assessment the following data will be collected:

Inter-incisor gap (cm) Mallampati test (1;2;3;4) Thyromental distance (cm) Prognathism (yes; no) Neck motility (\<80°;80-90°;\>90°) Total body weight (kg) History of difficult tracheal intubation (yes; no) Tracheal deviation at chest X-Ray (yes; no) Neck circumference (cm) Mediastinal goiter (yes; no) Histologic features (benign; carcinoma)

During the post-anesthesia it will be noted down the following:

Cormack scale (1; 2a; 2b; 3; 4) Number of necessary attempts to intubate (1;2;3;...) Time from induction to intubation (min) Necessity to use advanced airway management devices (Frova; Glidescope; Ambu-scope; fiber-optic; other)

Eligibility criteria: Inclusion Criteria:

* thyroid surgery

Exclusion Criteria:

* \<18 years

Primary outcomes:
measure: Difficult intubation incidence
timeFrame: through study completion, an average of 2 year
Secondary outcomes:
measure: Histologic features (benign; carcinoma) as predictive parameter for difficult intubation
timeFrame: through study completion, an average of 2 year
measure: Neck circumference (cm) as predictive parameter for difficult intubation
timeFrame: through study completion, an average of 2 year
measure: Tracheal deviation at chest X-Ray (yes; no) as predictive parameter for difficult intubation
timeFrame: through study completion, an average of 2 year
measure: History of difficult tracheal intubation (yes; no) as predictive parameter for difficult intubation
timeFrame: through study completion, an average of 2 year
measure: Total body weight (kg) as predictive parameter for difficult intubation
timeFrame: through study completion, an average of 2 year
measure: Neck motility (<80°;80-90°;>90°) as predictive parameter for difficult intubation
timeFrame: through study completion, an average of 2 year
measure: Thyromental distance (cm) as predictive parameter for difficult intubation
timeFrame: through study completion, an average of 2 year
measure: Mediastinal goiter (yes; no) as predictive parameter for difficult intubation
timeFrame: through study completion, an average of 2 year
measure: Prognathism (yes; no) as predictive parameter for difficult intubation
timeFrame: through study completion, an average of 2 year
measure: Mallampati test (1;2;3;4) as predictive parameter for difficult intubation
timeFrame: through study completion, an average of 2 year
measure: Inter-incisor gap (cm) as predictive parameter for difficult intubation
timeFrame: through study completion, an average of 2 year
Other outcomes:
Locations:
city: Padova
country: Italy
facility: University of Padova
Study officials:
References:
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citation: Meco BC, Alanoglu Z, Yilmaz AA, Basaran C, Alkis N, Demirer S, Cuhruk H. Does ultrasonographic volume of the thyroid gland correlate with difficult intubation? An observational study. Braz J Anesthesiol. 2015 May-Jun;65(3):230-4. doi: 10.1016/j.bjane.2014.06.004. Epub 2014 Oct 16.
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