Predictive Parameters for Difficult Tracheal Intubation Identification in Thyroid Surgery

Intubation;Difficult Clinical Trial

Official title:

Predictive Parameters for Difficult Tracheal Intubation Identification in Thyroid Surgery, a Observational Monocentric Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03578601
• Other study ID #: 4133/AO/17
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Intubation;Difficult

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