CTRI Number |
CTRI/2021/10/037576 [Registered on: 26/10/2021] Trial Registered Prospectively |
Last Modified On: |
20/10/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Case Control Study |
Study Design |
Other |
Public Title of Study
|
Evaluation of ultrasound measured tongue thickness, tongue thickness- thyromental distance ratio and skin to epiglottis distance in predicting difficult laryngoscopy. |
Scientific Title of Study
|
Evaluation of ultrasound measured tongue thickness, tongue thickness- thyromental distance ratio and skin to epiglottis distance in predicting difficult laryngoscopy. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Amit Rastogi |
Designation |
Associate professor |
Affiliation |
SGPGIMS |
Address |
Department of Anaesthesiology , SANJAY GANDHI POST GRADUATE INSTITUTE OF MEDICAL SCIENCES,LUCKNOW.
UTTAR PRADESH
India
Lucknow UTTAR PRADESH 226014 India |
Phone |
9793124468 |
Fax |
|
Email |
amit.rastogi.sgpgi@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Amit Rastogi |
Designation |
Associate professor |
Affiliation |
SGPGIMS |
Address |
Department of Anaesthesiology , SANJAY GANDHI POST GRADUATE INSTITUTE OF MEDICAL SCIENCES,LUCKNOW.
UTTAR PRADESH
India
Lucknow UTTAR PRADESH 226014 India |
Phone |
9793124468 |
Fax |
|
Email |
amit.rastogi.sgpgi@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Abhijeet kumar |
Designation |
JUNIOR RESIDENT |
Affiliation |
SGPGIMS |
Address |
Department of Anaesthesiology , SANJAY GANDHI POST GRADUATE INSTITUTE OF MEDICAL SCIENCES,LUCKNOW
UTTAR PRADESH
India Department of Anaesthesiology , SANJAY GANDHI POST GRADUATE INSTITUTE OF MEDICAL SCIENCES,LUCKNOW.
UTTAR PRADESH
2 Lucknow UTTAR PRADESH 226014 India |
Phone |
8004901609 |
Fax |
|
Email |
abhijeet56.sgpgi@gmail.com |
|
Source of Monetary or Material Support
|
SGPGIMS RAIBARELI. ROAD LUCKNOW |
|
Primary Sponsor
|
Name |
Sanjay Gandhi Postgraduate Institute of Medical Sciences |
Address |
Department of Anaesthesiology SGPGIMS LUCKNOW |
Type of Sponsor |
Research institution and hospital |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Amit rastogi |
Sanjay Ghandhi institute of medical sciences |
Anaesthesiology faculty SGPGIMS RAIBARELI ROAD LUCKNOW Lucknow UTTAR PRADESH |
8004904043
amit.rastogi.sgpgi@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
INSTITUTIONAL ETHICAL COMMITTEE,SGPGIMS |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
NIL |
Nil |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
1.ASAI and ASA II PATIENTS 2. Both males and females patients age >18 yrs of age 3.patients undergoing elective surgeries under GA with ETT |
|
ExclusionCriteria |
Details |
Non consenting patients,BMI >35kg/m2, H/o difficult airway
In past surgery,thyromental distance<5cm,inter incisor distance less than 2cm,restricted neck movement,maxilla facial anomalies, anatomical deformities,H/o trauma,surgery to upper airway CHANGE in Anaesthetic technique
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Other |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
prediction of difficult laryngoscopy with ultrasound measured tongue thickness, tongue thickness-thyromental distance ratio and skin to epiglottis distance. |
At baseline |
|
Secondary Outcome
|
Outcome |
TimePoints |
Prediction of difficult airway and difficult intubation |
1 year |
|
Target Sample Size
|
Total Sample Size="127" Sample Size from India="127"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
10/11/2021 |
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="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
Fulkerson JS, Moore HM, Anderson TS, Lowe RF Jr. Ultrasonography in the preoperative difficult airway assessment. J Clin Monit Comput. 2017 Jun;31(3):513- 530
2. Adhikari S, Zeger W, Schmier C, Crum T, Craven A, Frrokaj I, et al. Pilot study to determine the utility of point-of-care ultrasound in the assessment of difficult laryngoscopy. Acad Emerg Med. 2011
3. Ezri T, Gewürtz G, Sessler DI, Medalion B, Szmuk P, Hagberg C, et al. Prediction of difficult laryngoscopy in obese patients by ultrasound quantification of anterior neck soft tissue. Anaesthesia. 2003
4. Komatsu R, Sengupta P, Wadhwa A, Akça O, Sessler DI, Ezri T, et al. Ultrasound quantification of anterior soft tissue thickness fails to predict difficult laryngoscopy in obese patients. Anaesth Intensive Care. 2007
5. Wu J, Dong J, Ding Y, Zheng J. Role of anterior neck soft tissue quantifcations by ultrasound in predicting difficult laryngoscopy. Med Sci Monit. |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Endotracheal intubation is one of the most important skills for anesthesiologists in securing the airway during general anesthesia and resuscitation. Difficulties in handling airways optimally can lead to severe adverse effects and failure can also lead to mortality. Many clinical screening tests have been used to classify patients at risk of difficult laryngoscopy, but non have been shown to predict this complication with adequate sensitivity and specificity. Airway sonography is a noninvasive diagnostic device for bedside visualization and measurement of dimensions that may be linked to prediction of difficult airway management. Aims and objectives: Primary outcome measure: Prediction of difficult laryngoscopy with ultrasound measured tongue thickness, tongue thickness- thyromental distance ratio and skin to epiglottis distance. Secondary outcome measure: • Successful intubation • use of Adjuvants • Time of intubation till confirmation of ETT by capnography. Material and Methods Inclusion Criteria 1. ASA I and II patients 2. Both male and female patients of age >18 years of age 3. Patients undergoing elective surgeries under GA with ETT Exclusion Criteria Nonconsenting patients, BMI >35kg/m2 H/o difficult airway in the past surgeries Thyromental distance < 5 cm, inter incisor distance less than 2 cm, restricted neck movements. Maxillofacial anomalies/anatomical deformities/post burn contracture/neck deformities H/o trauma, surgery to upper airway Change in anaesthetic technique. All patients will undergo a detailed preoperative airway evaluation on the day before surgery. The modified Mallam Patti class, mouth opening, thyromental distance, inter incisor distance will be recorded during PAC. All patients will also View undergo a detailed prospective sonographic assessment by the same anesthesiologist and Tongue thickness will be File recorded. For sonographic assessment, the patient will be made to lie in a supine position. Mouth should be closed and tip of tongue should slightly touch incisors. Tongue should be relaxed and patient should not phonate during assessment. Curvilinear USG probe (high frequency 6-14mHz) is placed under chin in median sagittal plane and view is adjusted to visualize entire tongue clearly on screen. Maximum vertical dimension from surface of tongue to submental skin is measured and this is defined as tongue thickness. After measuring tongue thickness, skin to epiglottis distance will be measured. (method n view to be decided). The next day, the patient will be shifted to the operating room, baseline monitors of electrocardiogram, noninvasive blood pressure and pulse oximetry will be connected and values noted. direct laryngoscopy will be performed by an experienced anaesthesiologist using a curved Macintosh Blade and the Cormack- Lehane grading of Laryngoscopic view will be noted. In this study, laryngoscopy will be defined as easy if Cormack Lehane grading on Laryngoscopy was 1 or 2 and it will be defined as difficult if Cormack Lehane grading was 3 or 4. All laryngoscopies will done by a single experienced anaesthesiologist who will not be privy to preoperative ultrasound airway examination. Patients will then be intubated with an appropriate sized endotracheal tube and surgery will be allowed to proceed. At the end of the surgery, the patient will be extubated following reversal of neuromuscular blockade or shifted intubated to post operative ICU for as per indications. |