Predictive Parameters for Difficult Tracheal Intubation Identification in Thyroid Surgery

Completed

• Conditions: Intubation;Difficult
• Interventions: Other: Thyroid surgery

• Registration Number: NCT03578601
• Lead Sponsor: University of Padova

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.

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 Timeline

• Study Start: 2017-09-01
• Study First Submitted: 2018-02-19
• Study First Submitted QC: 2018-07-03
• Study First Posted: 2018-07-06
• Status Verified: 2018-09
• Primary Completion: 2018-09-17
• Study Completion: 2018-09-17
• Last Update Submitted: 2018-09-19
• Last Update Posted: 2018-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• thyroid surgery

Exclusion Criteria

• <18 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Thyroid surgery	Thyroid surgery	Patient undergoing thyroid surgery

Primary Outcome Measures

Name	Time	Method
Difficult intubation incidence	through study completion, an average of 2 year	Difficult intubation described as Cormack 3 or 4

Secondary Outcome Measures

Name	Time	Method
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
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
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
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
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
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
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
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
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
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
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

Trial Locations

Locations (1)

University of Padova; 🇮🇹 Padova, Italy