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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03578601
Other study ID # 4133/AO/17
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2017
Est. completion date September 17, 2018

Study information

Verified date September 2018
Source University of Padova
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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)


Recruitment information / eligibility

Status Completed
Enrollment 500
Est. completion date September 17, 2018
Est. primary completion date September 17, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- thyroid surgery

Exclusion Criteria:

- <18 years

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Thyroid surgery
Patient undergoing thyroid surgery

Locations

Country Name City State
Italy University of Padova Padova

Sponsors (1)

Lead Sponsor Collaborator
University of Padova

Country where clinical trial is conducted

Italy, 

References & Publications (6)

Amathieu R, Smail N, Catineau J, Poloujadoff MP, Samii K, Adnet F. Difficult intubation in thyroid surgery: myth or reality? Anesth Analg. 2006 Oct;103(4):965-8. — View Citation

Bouaggad A, Nejmi SE, Bouderka MA, Abbassi O. Prediction of difficult tracheal intubation in thyroid surgery. Anesth Analg. 2004 Aug;99(2):603-6, table of contents. — View Citation

Frova G, Sorbello M. Algorithms for difficult airway management: a review. Minerva Anestesiol. 2009 Apr;75(4):201-9. Epub 2008 Oct 23. Review. — View Citation

Khan MN, Rabbani MZ, Qureshi R, Zubair M, Zafar MJ. The predictors of difficult tracheal intubations in patients undergoing thyroid surgery for euthyroid goitre. J Pak Med Assoc. 2010 Sep;60(9):736-8. — View 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 — View Citation

Petrini F, Accorsi A, Adrario E, Agrò F, Amicucci G, Antonelli M, Azzeri F, Baroncini S, Bettelli G, Cafaggi C, Cattano D, Chinelli E, Corbanese U, Corso R, Della Puppa A, Di Filippo A, Facco E, Favaro R, Favero R, Frova G, Giunta F, Giurati G, Giusti F, Guarino A, Iannuzzi E, Ivani G, Mazzon D, Menarini M, Merli G, Mondello E, Muttini S, Nardi G, Pigna A, Pittoni G, Ripamonti D, Rosa G, Rosi R, Salvo I, Sarti A, Serafini G, Servadio G, Sgandurra A, Sorbello M, Tana F, Tufano R, Vesconi S, Villani A, Zauli M; Gruppo di Studio SIAARTI "Vie Aeree Difficili"; IRC e SARNePI; Task Force. Recommendations for airway control and difficult airway management. Minerva Anestesiol. 2005 Nov;71(11):617-57. English, Italian. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Difficult intubation incidence Difficult intubation described as Cormack 3 or 4 through study completion, an average of 2 year
Secondary Histologic features (benign; carcinoma) as predictive parameter for difficult intubation preoperative Histologic features (benign; carcinoma) as predictive parameter for difficult intubation through study completion, an average of 2 year
Secondary Neck circumference (cm) as predictive parameter for difficult intubation preoperative Neck circumference (cm) as predictive parameter for difficult intubation through study completion, an average of 2 year
Secondary Tracheal deviation at chest X-Ray (yes; no) as predictive parameter for difficult intubation preoperative Tracheal deviation at chest X-Ray (yes; no) as predictive parameter for difficult intubation through study completion, an average of 2 year
Secondary History of difficult tracheal intubation (yes; no) as predictive parameter for difficult intubation preoperative History of difficult tracheal intubation (yes; no) as predictive parameter for difficult intubation through study completion, an average of 2 year
Secondary Total body weight (kg) as predictive parameter for difficult intubation preoperative Total body weight (kg) as predictive parameter for difficult intubation through study completion, an average of 2 year
Secondary Neck motility (<80°;80-90°;>90°) as predictive parameter for difficult intubation preoperative Neck motility (<80°;80-90°;>90°) as predictive parameter for difficult intubation through study completion, an average of 2 year
Secondary Thyromental distance (cm) as predictive parameter for difficult intubation preoperative Thyromental distance (cm) as predictive parameter for difficult intubation through study completion, an average of 2 year
Secondary Mediastinal goiter (yes; no) as predictive parameter for difficult intubation preoperative Mediastinal goiter (yes; no) as predictive parameter for difficult intubation through study completion, an average of 2 year
Secondary Prognathism (yes; no) as predictive parameter for difficult intubation preoperative Prognathism (yes; no) as predictive parameter for difficult intubation through study completion, an average of 2 year
Secondary Mallampati test (1;2;3;4) as predictive parameter for difficult intubation preoperative Mallampati test (1;2;3;4) as predictive parameter for difficult intubation through study completion, an average of 2 year
Secondary Inter-incisor gap (cm) as predictive parameter for difficult intubation preoperative Inter-incisor gap (cm) as predictive parameter for difficult intubation through study completion, an average of 2 year
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