Obesity Clinical Trial
Official title:
Thyromental Height Test as a New Method for Prediction of Difficult Intubation in Obese Patients
Verified date | June 2020 |
Source | Medical University of Silesia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 300 |
Est. completion date | June 1, 2021 |
Est. primary completion date | June 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Poland | Medical University of Gdansk | Gdansk | Pomerania |
Poland | Samodzielny Publiczny Szpital Kliniczny nr 1 | Zabrze | Silesia |
Lead Sponsor | Collaborator |
---|---|
Medical University of Silesia |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | 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 | Thyromental distance (TMD). [cm] | Thyromental distance is measured during routine preoperative visit as a 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) with a depth gauge (21460605, Limit, Alingsås, Sweden) in millimetres, with the patient in supine position and closed mouth. | Preoperatively (an average of 24 hours) | |
Secondary | Sternomental distance (SMD). [cm] | Sternomental distance is measured during routine preoperative visit between the superior border of the manubrium sterni and the most anterior part of the mental prominence of the mandible with a tape measure (Standard, Hoechstmas, Sulzbach, Germany) as a distance in centimetres, with the patient in supine position, head fully extended, mouth closed. | Preoperatively (an average of 24 hours) | |
Secondary | Score in modified Mallampati test (MMT). | The oropharyngeal view is assessed according to modified Mallampati scale in sitting position, mouth maximally opened, tongue protruded, without phonation during routine preoperative anaesthetic visit. Grade I is assigned when the soft palate, uvula, fauces and pillars are fully visible, grade II when the soft palate, major part of uvula and fauces are visible, grade III when soft palate and base of uvula are visible and grade IV when only hard palate is visible. | Preoperatively (an average of 24 hours) | |
Secondary | Mouth opening (MO). [cm] | Mouth opening is measured as a distance between the lower and upper incisors with a tape measure (Standard, Hoechstmas, Sulzbach, Germany) in centimetres. Patients are in sitting position with mouth maximally opened, tongue retracted and without phonation. | Preoperatively (an average of 24 hours) | |
Secondary | Neck circumference (NC). [cm] | Neck circumference is measured at the level of the cricoid cartilage horizontally with a tape measure (Standard, Hoechstmas, Sulzbach, Germany) as a circumference in centimetres in the sitting position during routine preoperative visit. | Preoperatively (an average of 24 hours) | |
Secondary | Intubation time. [s] | Intubation time is defined as a time from direct laryngoscopy commencement to confirmation of endotracheal tube placement and noted during induction of general anaesthesia. | Intraoperatively (an average of 5 minutes) | |
Secondary | Intubation difficulty. | Subjective evaluation of intubation difficulty is noted during induction of general anaesthesia. Grade I is defined as an easy intubation, grade II a moderate intubation and grade III as a difficult intubation. | Intraoperatively (an average of 5 minutes) | |
Secondary | Number of intubation attempts. | Number of intubation attempts defined as a failed direct laryngoscopy without the use of endotracheal tube or insertion of endotracheal tube beyond the teeth line is noted during induction of general anaesthesia. | Intraoperatively (an average of 5 minutes) | |
Secondary | Use of bougie. | Necessity to use bougie during induction of general anaesthesia is noted. | Intraoperatively (an average of 5 minutes) | |
Secondary | Technique modification. | Necessity to modify technique of laryngoscopy or intubation is noted. | Intraoperatively (an average of 5 minutes) |
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