NCT03578601

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2018

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 6, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 17, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2018

Completed
Last Updated

September 20, 2018

Status Verified

September 1, 2018

Enrollment Period

1 year

First QC Date

February 19, 2018

Last Update Submit

September 19, 2018

Conditions

Intubation;Difficult

Keywords

IntubationDifficultthyroid

Outcome Measures

Primary Outcomes (1)

  • Difficult intubation incidence

    Difficult intubation described as Cormack 3 or 4

    through study completion, an average of 2 year

Secondary Outcomes (11)

  • 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

    through study completion, an average of 2 year

  • 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

    through study completion, an average of 2 year

  • Total body weight (kg) as predictive parameter for difficult intubation

    through study completion, an average of 2 year

  • +6 more secondary outcomes

Study Arms (1)

Thyroid surgery

Patient undergoing thyroid surgery

Other: Thyroid surgery

Interventions

Thyroid surgeryOTHER

Patient undergoing thyroid surgery

Thyroid surgery

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients undergoing thyroid surgery

You may qualify if:

  • thyroid surgery

You may not qualify if:

  • \<18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Padova

Padua, 35127, Italy

Location

Related Publications (6)

  • 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.

    PMID: 16278626BACKGROUND

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

    PMID: 18946426BACKGROUND

  • 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.

    PMID: 15271749RESULT

  • 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.

    PMID: 17000813RESULT

  • 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.

    PMID: 25925037RESULT

  • 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.

    PMID: 21381580RESULT

MeSH Terms

Conditions

Thyroid Diseases

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

February 19, 2018

First Posted

July 6, 2018

Study Start

September 1, 2017

Primary Completion

September 17, 2018

Study Completion

September 17, 2018

Last Updated

September 20, 2018

Record last verified: 2018-09

Locations

IT(1)