Predictive Parameters for Difficult Tracheal Intubation Identification in Thyroid Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Intubation;Difficult
• Intervention / Treatment: Other: 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)

• Study Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• Italy
  • Padova, Italy, 35127
    • University of Padova

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients undergoing thyroid surgery

Description

Inclusion Criteria:

• thyroid surgery

Exclusion Criteria:

• <18 years

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Thyroid surgery; Patient undergoing thyroid surgery	Other: Thyroid surgery; Patient undergoing thyroid surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difficult intubation incidence	Difficult intubation described as Cormack 3 or 4	through study completion, an average of 2 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Padova

Publications and helpful links

General Publications

• Petrini F, Accorsi A, Adrario E, Agro 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. No abstract available. English, Italian.
• Frova G, Sorbello M. Algorithms for difficult airway management: a review. Minerva Anestesiol. 2009 Apr;75(4):201-9. Epub 2008 Oct 23.
• 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. doi: 10.1213/01.ANE.0000122634.69923.67.
• 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. doi: 10.1213/01.ane.0000237305.02465.ee.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): September 17, 2018
• Study Completion (Actual): September 17, 2018

Study Registration Dates

• First Submitted: February 19, 2018
• First Submitted That Met QC Criteria: July 3, 2018
• First Posted (Actual): July 6, 2018

Study Record Updates

• Last Update Posted (Actual): September 20, 2018
• Last Update Submitted That Met QC Criteria: September 19, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: thyroid; Intubation; Difficult
• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases
• Other Study ID Numbers: 4133/AO/17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Probably all IPD will be shared at the end of the study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No