| CTRI Number |
CTRI/2017/12/010921 [Registered on: 20/12/2017] Trial Registered Retrospectively |
| Last Modified On: |
20/12/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparision of two methods of assessment of the ease of visualisation of airway for airway tube placement for ventilation in patients under general anaesthesia undergoing an operation.A study in Indian population. |
|
Scientific Title of Study
|
Comparision of airway assessment by Mallampati Classification and Cormack Lehane grading in Indian population. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ramapati Sanyal |
| Designation |
Associate Professor |
| Affiliation |
KPC Medical College |
| Address |
Deptt. of Anaesthesiology
K P C Medical College
1F Raja S C Mullick Road
Jadavpur
Kolkata
Kolkata
WEST BENGAL
700032
India |
| Phone |
|
| Fax |
|
| Email |
sanyalramapati@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ramapati Sanyal |
| Designation |
Associate Professor |
| Affiliation |
KPC Medical College |
| Address |
Deptt. of Anaesthesiology
K P C Medical College
1F Raja S C Mullick Road
Jadavpur
Kolkata
Kolkata
WEST BENGAL
700032
India |
| Phone |
|
| Fax |
|
| Email |
sanyalramapati@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ramapati Sanyal |
| Designation |
Associate Professor |
| Affiliation |
KPC Medical College |
| Address |
Deptt. of Anaesthesiology
K P C Medical College
1F Raja S C Mullick Road
Jadavpur
Kolkata
Kolkata
WEST BENGAL
700032
India |
| Phone |
|
| Fax |
|
| Email |
sanyalramapati@gmail.com |
|
|
Source of Monetary or Material Support
|
| KPC Medical College
1F Raja S C Mullick Road
Jadavpur
Kolkata 700032
West Bengal
India |
|
|
Primary Sponsor
|
| Name |
KPC Medical College |
| Address |
1F Raja S C Mullick Road
Jadavpur
Kolkata 700032
West Bengal
India |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Ramapati Sanyal |
KPC Medical College |
Deptt. of Anaesthesiology
1F Raja S C Mullick Road
Jadavpur
Kolkata 700032
Kolkata
WEST BENGAL |
9830163182
sanyalramapati@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
patients undergoing general anaesthesia for various operations at the hospital, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with American Society of Anaesthesiologists grade I and II. |
|
| ExclusionCriteria |
| Details |
1.Patients not willing to participate.
2.Emergency surgical procedures.
3.Pregnant patients.
4.Patients with unstable cervical spine,head and neck anomaly,tumour of head and neck
5.Edentulous or partial loss of denture.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| NIL |
immediate |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
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)
|
13/11/2017 |
| 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="0"
Months="2"
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
|
Intubation is of prime importance for securing airway in patients undergoing general anaesthesia. Airway assessment before anaesthetising the patient reduces the incidence of failure of intubation and its subsequent complications. Assessment of airway by Mallampati Method is a common bwd side clinical method to predict difficult intubation. Cormack Lehane grading is airway assessment at laryngoscopy. The aim of the present study is to compare the above two methods and find out a correlation between the two. |