| CTRI Number |
CTRI/2017/09/009819 [Registered on: 18/09/2017] Trial Registered Retrospectively |
| Last Modified On: |
16/09/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Asessment of airway in predicting difficulty in introducing endotracheal tube. |
|
Scientific Title of Study
|
A comparison of thyromental height with ratio of patients height to thyromental distance and the upper lib bite test in predicting difficult laryngoscopy. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| D2014038 |
Protocol Number |
| SRS/1034/114 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Smruti Mathurvaishya |
| Designation |
Third Year Resident |
| Affiliation |
Lokmanya Tilak Medical Municipal Hospital |
| Address |
B15 Sumitra Farro Nagar ,C.H.S. Lewis Wadi Thane (West)
Mumbai-400604
L.T.M.M.C. and L.T.M.G.H,
Sion,
Mumbai -400022
Maharashtra
Mumbai
MAHARASHTRA
400604
India |
| Phone |
9821158340 |
| Fax |
02224063262 |
| Email |
mathur.smruti@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shalaka Nellore |
| Designation |
Associate Professor |
| Affiliation |
Lokmanya Tilak Medical Municipal Hospital |
| Address |
904,Adonis,Raheja Acropolis II,V.N.Purav Marg, Deonar Mumbai 400088
L.T.M.M.C. and L.T.M.G.H,
Sion,
Mumbai -400022
Maharashtra
Mumbai
MAHARASHTRA
400088
India |
| Phone |
9820625058 |
| Fax |
02224063262 |
| Email |
drgshalaka@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shalaka Nellore |
| Designation |
Associate Professor |
| Affiliation |
Lokmanya Tilak Medical Municipal Hospital |
| Address |
904,Adonis,Raheja Acropolis II,V.N.Purav Marg, Deonar Mumbai 400088
L.T.M.M.C. and L.T.M.G.H,
Sion,
Mumbai -400022
Maharashtra
Osmanabad
MAHARASHTRA
400088
India |
| Phone |
9820625058 |
| Fax |
02224063262 |
| Email |
drgshalaka@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lokmanya Tilak Municipal Medical Hospital and Lokmanya Tilak Municipal General hospital,Sulochana Shetty Marg,Sion,Mumbai -400022 |
|
|
Primary Sponsor
|
| Name |
Dr Shalaka Nellore |
| Address |
Dept of Anaesthesiology Lokmanya Tilak Municipal Medical College
and General Hospital Sion Mumbai 400022 |
| 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 Smruti Mathurvaishya |
Lokmanya Tilak Medical Municipal Hospital |
Lokmanya Tilak Medical general hospital & Lokmanya Tilak Medical Municipal College,department of anaesthesia, Sion,Mumbai. 400022
Mumbai
MAHARASHTRA |
9821158340
mathur.smruti@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Lokmanya Tilak Medical general hospital Staff and Research society |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Adult patients undergoing surgery under general anaesthesia with endotracheal intubation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Paatients of American society of anaesthesia class I and II requiring general anaesthesia with endotracheal intubation
|
|
| ExclusionCriteria |
| Details |
1.patients unwilling for measurements
2.Edentulous patients
3.Patients with restricted cervical movements
4.Patients with neck contracture
5.Patients with oropharyngeal and laryngeal pathology
6.Patients with fractured mandible
7.Patients unable to sit or stand erect
8.Patients requiring awake intubation
9.Patients with visible neck swelling |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of airway predictor; Thyromental height,Ratio of patients height to thyromental distance,Upper lip bite test in predicting difficult laryngoscopy by the Cormack and Lehane grading system |
Evaluation will be done pre-opertaively, when the patient is examined for fitness for surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "301"
Final Enrollment numbers achieved (India)="301" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2014 |
| Date of Study Completion (India) |
15/12/2015 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
An important responsibility of the anaesthesiologist is to maintain a patent airway as failure to secure the airway and interrupt gas exchange, for even a few minutes can be fatal and catastrophic leading to permanent brain damage. Several airway predictors have been utilised to assess the airway and predict difficult laryngoscopy and intubation. The incidence of difficult laryngoscopy in literature has been reported to be 1.5% to 20%. In this observational study we chose to evaluate and compare the newer airway indices such as the Thyromental Height, Ratio of patients height to Thyromental distance and the Upper lip bite test individually and in combination for predicting difficult laryngoscopy using the Cormack and Lehane grading system. |