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Completed

NCT Number: NCT03578601

Predictive Parameters for Difficult Tracheal Intubation Identification in Thyroid Surgery

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.

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Key information

Conditions

Intubation;Difficult Endocrine System Diseases Thyroid Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Padova

Padova, 35127, Italy

About this 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.

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • thyroid surgery

Exclusion criteria

  • <18 years

Treatment and study plan

Thyroid surgery

Other

Patient undergoing thyroid surgery

Primary outcomes

  1. Difficult intubation incidence

    Time frame: through study completion, an average of 2 year

    Difficult intubation described as Cormack 3 or 4

Secondary outcomes

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: through study completion, an average of 2 year

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

Sponsors and collaborators

Lead sponsor

University of Padova

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 6, 2018
Registry last updated
Sep 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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