| CTRI Number |
CTRI/2017/10/010267 [Registered on: 31/10/2017] Trial Registered Retrospectively |
| Last Modified On: |
28/01/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Oral cavity volume for the prediction of difficulty in placing tube in wind-pipe. |
|
Scientific Title of Study
|
Oropharyngeal Volume as a predictor of difficult airway: An observational study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR Neha Singh |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
Department of Anaesthesiology
All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar, Pin-751019
Odisha, India
Khordha
ORISSA
751019
India |
| Phone |
9438884045 |
| Fax |
|
| Email |
hinehabhu@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR NEHA SINGH |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, BHUBANESWAR |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, BHUBANESWAR, PIN-751019, ODISHA, INDIA
ORISSA
751019
India |
| Phone |
9438884045 |
| Fax |
|
| Email |
hinehabhu@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR NEHA SINGH |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, BHUBANESWAR |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, BHUBANESWAR, PIN-751019, ODISHA, INDIA
ORISSA
751019
India |
| Phone |
9438884045 |
| Fax |
|
| Email |
hinehabhu@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Sijua, Patrapada, bhubaneswar, Pin-751019
Odisha, India |
|
|
Primary Sponsor
|
| Name |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES BHUBANESWAR |
| Address |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES BHUBANESWAR PIN 751019
ODISHA INDIA |
| 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 Neha Singh |
All India Institute of Medical Sciences, Bhubaneswar |
Theatre Complex, G Block, Near Casualty, Department of Anaesthesiology, AIIMS, Bhubaneswar, Pin-751019
Khordha
ORISSA |
9438884045
hinehabhu@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, BHUBANESWAR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients posted for surgery under general anaesthesia., |
|
|
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 |
Patients of either sex aged 18 – 70 years, ASA grade I-II undergoing elective surgeries under general anaesthesia will be included. |
|
| ExclusionCriteria |
| Details |
Mentally challenged patients, Patients with neurological deficit. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Role of oropharyngeal volume in prediction of difficult airway. |
At the time of intubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate optimal cut off oropharyngeal volume for difficult airway. |
After completion of the study. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="215" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/07/2017 |
| Date of Study Completion (India) |
28/11/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
28/11/2018 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NONE |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Unanticipated difficult tracheal intubation is an important cause of morbidity and mortality. Several tests are described to predict difficult airway, but most of them are combined together as scoring system. Many scoring systems have been developed to identify possible difficult intubation till date but none of these appear to be solely the best. 1 - 3 Thus suggestions for a combination of these tests have been evolved over time for a better prediction. 4-5 We hypothesize that the actual volume of the oral cavity plays a role in determining the difficulty in laryngoscopy and intubation. So oropharyngeal volume can predict difficult laryngoscopy and intubation. Therefore, this prospective study is planned to estimate the effectiveness of oropharyngeal volume as a predictor for difficult laryngoscopy and intubation. |