Thyromental Height Test as a New Method for Prediction of Difficult Intubation in Obese Patients

NCT04439487 | Unknown

• 1 other identifier: TMHT-02
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

Brief Summary

The main objective of this trial is to assess the clinical usefulness of thyromental height test (TMHT) in prediction of difficult intubation in obese patients scheduled for elective surgical procedures. The secondary aim is to evaluate usefulness of other commonly used predictive tests associated with difficult intubation in obese patients.

Conditions

Intubation, Intratracheal; Obesity; Predictive Value of Tests

Keywords

Difficult Intubation; Obesity; Thyromental Height Test

Outcome Measures

Primary Outcomes (2)

• Score in Cormack-Lehane scale (CL).

  During direct laryngoscopy after the induction of general anesthesia the laryngeal view is graded in Cormack-Lehane Scale by the laryngoscopist. Grade I is assigned when the glottis is fully visible, grade II when the glottis is partially visible, grade III when only the epiglottis is visible and grade IV when neither glottis nor epiglottis is visible.

  Intraoperatively (an average of 5 minutes)

• Thyromental height (TMH). [mm]

  Thyromental height is defined as the height between the anterior border of the thyroid cartilage (on the thyroid notch just between the 2 thyroid laminae) and the anterior border of the mentum (on the mental protuberance of the mandible). It is measured with a depth gauge during routine preoperative anaesthetic visit in supine position and closed mouth.

  Preoperatively (an average of 24 hours)

Secondary Outcomes (10)

• Thyromental distance (TMD). [cm]

  Preoperatively (an average of 24 hours)

• Sternomental distance (SMD). [cm]

  Preoperatively (an average of 24 hours)

• Score in modified Mallampati test (MMT).

  Preoperatively (an average of 24 hours)

• Mouth opening (MO). [cm]

  Preoperatively (an average of 24 hours)

• Neck circumference (NC). [cm]

  Preoperatively (an average of 24 hours)

Study Arms (1)

Obese patients requiring general anesthesia

Group consists of consecutive, adult, obese patients undergoing elective surgical procedures requiring general anaesthesia, direct laryngoscopy and intubation. All patients undergo general anesthesia according to a standardised protocol. They are preoxygenated with 100% oxygen breathed through a face mask for 3-5 minutes. Induction of general anaesthesia is achieved with propofol 1,5-2 mg·kg-1 (of Ideal Body Weight) and 0,1mg fentanyl or sufentanil 10µg. Muscle relaxation is accomplished with rocuronium 0.6 mg ·kg-1 (of Ideal Body Weight). Depth of muscular blockade is monitored using Train of Four (TOF) method. The first laryngoscopy attempt is performed at TOF 0. The patient is placed in an optimal, sniffing or ramped position as appropriate and a #3 or #4 Macintosh blade is used. Successful intubation is confirmed with bilateral auscultation and capnography.

Diagnostic Test: Anthropometric measurements during routine preoperative visit; Other: Assesment of intubation parameters during induction of general anaesthesia

Interventions

Anthropometric measurements during routine preoperative visit DIAGNOSTIC_TEST

During routine preoperative anaesthetic visit and physical examination the following predictive test measurements are obtained by a research team member not involved in the further assessment of laryngoscopy: score in modified Mallampati test, Thyromental height, Sternomental distance, Thyromental distance, Neck circumference, Mouth opening distance

Obese patients requiring general anesthesia

Assesment of intubation parameters during induction of general anaesthesia OTHER

During induction of general anaesthesia and intubation research team member not involved in obtaining anthropometric measurements notes Number of intubation attempts, Intubation time, Subjective intubation difficulty, Use of bougie and Need of technique modification.

Obese patients requiring general anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Studied population will consist of consecutive obese, adult patients (BMI ≥30 kg/m2) qualified for elective surgical procedures, requiring general anaesthesia, direct laryngoscopy and intubation.

You may qualify if:

• qualification for elective surgical procedures, requiring general anaesthesia, direct laryngoscopy and intubation
• consent for participation in the trail
• age ≥18 years
• BMI ≥30 kg/m2

You may not qualify if:

• BMI ≤30 kg/m2
• patients overweight due to ascites or tumor
• emergency procedures
• visible anatomic abnormalities
• patients scheduled for awake fibreoptic intubation
• intubation failure
• lack of consent for participation in the trail

Sponsors & Collaborators

• Medical University of Silesia: lead

Study Sites (2)

Medical University of Gdansk

Gdansk, Pomeranian Voivodeship, 80-214, Poland

Location

Samodzielny Publiczny Szpital Kliniczny nr 1

Zabrze, Silesian Voivodeship, 41-800, Poland

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 19, 2020
• Study Start: June 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: June 19, 2020

Record last verified: 2020-06

Locations

PL (2)