| CTRI Number |
CTRI/2018/05/014321 [Registered on: 31/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
16/05/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
comparison of different indices in predicting difficult airway |
|
Scientific Title of Study
|
Comparison of the Ratio of patients height to thyromental distance versus the Modified Mallampati versus the Upper Lip Bite Test 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 |
Pooja P |
| Designation |
Primary DNB Resident |
| Affiliation |
Kerala institute of medical sciences |
| Address |
Kerala institute of medical sciences
Pb.no 1
Anayara
Thiruvananthapuram
KERALA
695029
India |
| Phone |
9400996342 |
| Fax |
914712443565 |
| Email |
pooja.plan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sherly John |
| Designation |
Consultant Anaesthesiologist |
| Affiliation |
Kerala Institute Of Medical Science |
| Address |
Kerala institute of medical sciences
Pb.no 1
Anayara
Trivandrum
Thiruvananthapuram
KERALA
695029
India |
| Phone |
8129603624 |
| Fax |
914712443565 |
| Email |
sherlyjohn24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sherly John |
| Designation |
Consultant Anaesthesiologist |
| Affiliation |
Kerala Institute Of Medical Science |
| Address |
Kerala institute of medical sciences
Pb.no 1
Anayara
Trivandrum
KERALA
695029
India |
| Phone |
8129603624 |
| Fax |
914712443565 |
| Email |
sherlyjohn24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kerala institute of medical sciences
Pb.no 1
Anayara
Trivandrum
kerala
695029 |
|
|
Primary Sponsor
|
| Name |
Kerala Institute Of Medical Science |
| Address |
pb.no 1
Anayara
trivandrum 29 |
| 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 |
| Pooja P |
Kerala institute of medical sciences |
Pb No.1
Anayara p.o
Trivandrum
Thiruvananthapuram
KERALA |
9400996342
pooja.plan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ASA 2, |
|
|
Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA Physical status 1-3
2.Patients posted for elective surgeries schedule to receive general anesthesia (Orthopedic, ENT, Abdominal, Urologic and Gynecological procedures)
3.Age between 18-65 years.
|
|
| ExclusionCriteria |
| Details |
1.Uncooperative and unwilling patients.
2.History of burns, trauma or surgeries to airway.
3.Tumors or mass in the neck or the airway.
4.Patients with restricted mobility at neck and mandible.
5.Patients with inability to sit, edentulous or need awake intubation.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the predictive value of ratio of patient’s height to thyromental distance, modified Mallampati classification, and upper lip bite test in difficult laryngoscopy
|
september 2019 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
not applicable
|
not applicable
|
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
28/11/2017 |
| 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" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In this study, comparison of predictive value of the ratio of patient’s height to thyromental distance with the modified mallampati and the upper lip bite test as methods of airway assessments for difficult laryngoscopy will be done.Study will be done on 100 consenting patients with ASA physical status 1-3 aged between 18-65 yrs scheduled to receive general anesthesia requiring endotracheal intubation for elective orthopedic ,ENT, urologic, abdominal and gynecological surgery. The principal investigator measures the thyromental distance from the bony point of the mentum to thyroid notch.Height of the patient will be measured in cm from vertex to heel with the patient in standing position and will calculate RHTMD.MMT and ULBT will also be assesses preoperatively.The difficulty in laryngoscopy is assessed at the time of intubation.
The efficacy in predicting difficulty in laryngoscopy will be compared with RHTMD,MMT,ULBT. |