Predictive Parameters for Difficult Tracheal Intubation Identification in Thyroid Surgery

Sponsor
University of Padova (Other)
Overall Status
Completed
CT.gov ID
NCT03578601
Collaborator
(none)
500
1
12.5
39.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Predictive Parameters for Difficult Tracheal Intubation Identification in Thyroid Surgery, a Observational Monocentric Prospective Study
Actual Study Start Date :
Sep 1, 2017
Actual Primary Completion Date :
Sep 17, 2018
Actual Study Completion Date :
Sep 17, 2018

Arms and Interventions

Arm Intervention/Treatment
Thyroid surgery

Patient undergoing thyroid surgery

Other: Thyroid surgery
Patient undergoing thyroid surgery

Outcome Measures

Primary Outcome Measures

  1. Difficult intubation incidence [through study completion, an average of 2 year]

    Difficult intubation described as Cormack 3 or 4

Secondary Outcome Measures

  1. Histologic features (benign; carcinoma) as predictive parameter for difficult intubation [through study completion, an average of 2 year]

    preoperative Histologic features (benign; carcinoma) as predictive parameter for difficult intubation

  2. Neck circumference (cm) as predictive parameter for difficult intubation [through study completion, an average of 2 year]

    preoperative Neck circumference (cm) as predictive parameter for difficult intubation

  3. Tracheal deviation at chest X-Ray (yes; no) as predictive parameter for difficult intubation [through study completion, an average of 2 year]

    preoperative Tracheal deviation at chest X-Ray (yes; no) as predictive parameter for difficult intubation

  4. History of difficult tracheal intubation (yes; no) as predictive parameter for difficult intubation [through study completion, an average of 2 year]

    preoperative History of difficult tracheal intubation (yes; no) as predictive parameter for difficult intubation

  5. Total body weight (kg) as predictive parameter for difficult intubation [through study completion, an average of 2 year]

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

  6. Neck motility (<80°;80-90°;>90°) as predictive parameter for difficult intubation [through study completion, an average of 2 year]

    preoperative Neck motility (<80°;80-90°;>90°) as predictive parameter for difficult intubation

  7. Thyromental distance (cm) as predictive parameter for difficult intubation [through study completion, an average of 2 year]

    preoperative Thyromental distance (cm) as predictive parameter for difficult intubation

  8. Mediastinal goiter (yes; no) as predictive parameter for difficult intubation [through study completion, an average of 2 year]

    preoperative Mediastinal goiter (yes; no) as predictive parameter for difficult intubation

  9. Prognathism (yes; no) as predictive parameter for difficult intubation [through study completion, an average of 2 year]

    preoperative Prognathism (yes; no) as predictive parameter for difficult intubation

  10. Mallampati test (1;2;3;4) as predictive parameter for difficult intubation [through study completion, an average of 2 year]

    preoperative Mallampati test (1;2;3;4) as predictive parameter for difficult intubation

  11. Inter-incisor gap (cm) as predictive parameter for difficult intubation [through study completion, an average of 2 year]

    preoperative Inter-incisor gap (cm) as predictive parameter for difficult intubation

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • thyroid surgery
Exclusion Criteria:
  • <18 years

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Padova Padova Italy 35127

Sponsors and Collaborators

  • University of Padova

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Alessandro De Cassai, Medical Doctor, University of Padova
ClinicalTrials.gov Identifier:
NCT03578601
Other Study ID Numbers:
  • 4133/AO/17
First Posted:
Jul 6, 2018
Last Update Posted:
Sep 20, 2018
Last Verified:
Sep 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Alessandro De Cassai, Medical Doctor, University of Padova
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 20, 2018