NCT04439487|Unknown
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Sponsor study identifier
observational
300
1 country
2
Study Start
June 1, 2020
Actual (reported)Primary Completion
June 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 1, 2020
Actual (reported)June 4, 2020
Actual (reported)June 19, 2020
Actual (reported)June 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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)
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)
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.
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
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.
Medical University of Gdansk
Gdansk, Pomeranian Voivodeship, 80-214, Poland
Samodzielny Publiczny Szpital Kliniczny nr 1
Zabrze, Silesian Voivodeship, 41-800, Poland
First Submitted
June 4, 2020
First Posted
June 19, 2020
Study Start
June 1, 2020
Actual (reported)Primary Completion
June 1, 2021
Estimated (date passed)Use of USG in Difficult Airway in Obese
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.
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 19, 2020
Record last verified: 2020-06
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Source: ClinicalTrials.gov.
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