| CTRI Number |
CTRI/2019/03/018122 [Registered on: 15/03/2019] Trial Registered Prospectively |
| Last Modified On: |
13/03/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
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Type of Study
|
Comparative |
| Study Design |
Other |
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Public Title of Study
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To compare the height between thyroid cartilage and chin, and the ratio of two distances i.e. the distance between the hyoid bone and the chin in extended and neutal neck positions for predicting difficult intubation in adults who have to be electively operated under general anaesthesia. |
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Scientific Title of Study
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Comparison of thyromental height and sonographic hyomental distance ratio in predicting difficult intubation in adults undergoing elective surgery under general anaesthesia. |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Parul Sood |
| Designation |
PGJR Department of Anaesthesia and Intensive Care, GMCH 32 Chandigarh |
| Affiliation |
Government Medical College and Hospital Sector 32 Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, Government Medical College and Hospital, sector 32 Chandigarh
House no. 485 top floor sector 15 A Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9815105081 |
| Fax |
|
| Email |
parulsood77@gmail.com |
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Details of Contact Person
Scientific Query
|
| Name |
Richa Saroa |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College and Hospital Sector 32 Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, Government Medical College and Hospital, sector 32 Chandigarh
House no. 485 top floor sector 15 A Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121513 |
| Fax |
|
| Email |
richajayant@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Richa Saroa |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College and Hospital Sector 32 Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, Government Medical College and Hospital, sector 32 Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121513 |
| Fax |
|
| Email |
richajayant@rediffmail.com |
|
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Source of Monetary or Material Support
|
| Government Medical College and Hospital Sector 32 Chandigarh |
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Primary Sponsor
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| Name |
Government Medical College and Hospital Sector Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, Government Medical College and Hospital, sector 32 Chandigarh |
| Type of Sponsor |
Government medical college |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Parul Sood |
Government Medical College and Hospital, sector 32 Chandigarh |
Department of Anaesthesia and Intensive Care, Government Medical College and Hospital, sector 32 Chandigarh
Chandigarh
CHANDIGARH |
9815105081
parulsood77@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE (GMCH Chandigarh) |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical, |
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Intervention / Comparator Agent
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Inclusion Criteria
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| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients scheduled to undergo elective surgical procedures under general anaesthesia followed by endotracheal intubation.
2.American Society of Anaesthesiologists (ASA) physical status â… or â…¡.
|
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| ExclusionCriteria |
| Details |
1.Patient refusal.
2.Patients undergoing emergency lifesaving procedures.
3.Pregnant patients.
4.Bearded men.
5.Patients with maxillofacial injuries or deformities.
6.Patients with anatomical abnormalities altering the airway.
7.Patients with neuromuscular disorders and cervical spine injuries.
8.Patients with BMI > 35kg/m2 |
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Method of Generating Random Sequence
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Not Applicable |
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Method of Concealment
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Not Applicable |
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Blinding/Masking
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Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| To compare thyromental height (TMH) and sonographic hyomental distance ratio (HMDR) in predicting difficult endotracheal intubation in adults undergoing elective surgery under general anaesthesia. |
Thyromental height and Sonographic hyomental distance ratio will be measured preoperatively. Intraoperatively, Cormack Lehane grading and Percentage of glottic opening scoring will be done. |
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Secondary Outcome
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| Outcome |
TimePoints |
| To compare these two tests viz thyromental height and sonographic hyomental distance ratio with other established tests of airway assessment viz: modified Mallampatti test (MMT), thyromental distance (TMD) and sternomental distance (SMD). |
The established tests of airway assessment viz: modified Mallampatti test (MMT), thyromental distance (TMD) and sternomental distance (SMD) will be assessed in the preoperative setting.
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Target Sample Size
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Total Sample Size="400"
Sample Size from India="400"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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N/A |
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Date of First Enrollment (India)
|
30/03/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
None yet |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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Being competent in airway management is an indispensable skill for every anaesthesiologist. Inability to deal with it exposes a patient to the risk of injury and death. Difficult airway is defined as a clinical situation in which a conventionally trained anaesthesiologist experiences difficulty with ventilation of the upper airway with bag and mask or endotracheal intubation or both. The search for predictors of a difficult airway has been ongoing since the very first intubation was performed. Many morphological parameters have been suggested for the same. These include the modified Mallampatti test (MMT), upper lip bite test (ULBT), inter incisor gap (IIG), degree of neck movement, sternomental distance (SMD) and thyromental distance (TMD). These conventional tests are simple, take minimum time, are comfortable for the patient, reproducible and can be measured manually without the need of any equipment. In spite of these benefits, none of these tests, when used individually, is conclusive on its own. So, the anaesthesiologist has to perform all these tests to get a better prediction rate for the presence of a difficult airway. Thyromental height (TMH) and sonographic hyomental distance ratio (HMDR) are both newly proposed tests for predicting a difficult airway. Thyromental height is the height between the anterior border of the thyroid cartilage and the anterior border of mentum. It is measured with the patient lying supine with his/her mouth closed. A cut off value of 5 cm has been considered as a good correlative predictor of difficult airway. Hyomental distance ratio (HMDR) is the ratio of the hyomental distance (the distance between the hyoid bone and the tip of the chin) at the extreme of head extension (HMDe) and in the neutral position (HMDn). Cut off value of sonographic hyomental distance ratio of 1.2 has been shown to predict a difficult airway.There is limited research on the above said parameters i.e thyromental height and sonographic hyomental distance ratio in comparison to each other so as to predict difficult airway in patients scheduled to undergo general anaesthesia. Therefore, the present study aims to compare these two tests amongst themselves as well as with the conventional tests like MMT, TMD and SMD to determine the method of airway assessment that has the highest sensitivity and specificity. |