| CTRI Number |
CTRI/2019/12/022445 [Registered on: 19/12/2019] Trial Registered Prospectively |
| Last Modified On: |
13/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
COMPARATIVE STUDY |
| Study Design |
Other |
|
Public Title of Study
|
A Comparative Study for Prediction of Difficulty of laryngoscopic Endotracheal Intubation in Operation Theatre by Measuring Patient Height and Neck Before Coming to Operation Theatre. |
|
Scientific Title of Study
|
A comparative study to evaluate difficulty of laryngoscopic endotracheal intubation by using ratio of patient height to thyromental distance, ratio of neck circumference to thyromental distance and thyromental height in adult patients in tertiary care centre |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sukhdev Rao |
| Designation |
Junior Resident |
| Affiliation |
Dr. S. N. Medical College And Associated Group Of Hospitals, Jodhpur ( Rajasthan ) |
| Address |
Department Of Anaesthesiology, MDM Hospital, Shashtri Nagar, Jodhpur
Dr. S. N. Medical College, Shashtri Nagar, Jodhpur (Rajasthan )
Jodhpur
RAJASTHAN
342001
India |
| Phone |
8829956509 |
| Fax |
|
| Email |
sdrao2006@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr U D Sharma |
| Designation |
Senior Professor and Head of department |
| Affiliation |
Dr. S. N. Medical College And Associated Group Of Hospitals, Jodhpur ( Rajasthan ) |
| Address |
Department Of Anaesthesiology, Dr. S.N. Medical College, Shashtri Nagar, Jodhpur.
Department of Anaesthesiogy,MGH hospital , near Jalori gate,Jodhpur (Rajasthan )
Jodhpur
RAJASTHAN
342001
India |
| Phone |
9828036002 |
| Fax |
|
| Email |
doctorudsharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sukhdev Rao |
| Designation |
Junior Resident |
| Affiliation |
Dr. S. N. Medical College And Associated Group Of Hospitals, Jodhpur ( Rajasthan ) |
| Address |
Department of Anaesthesiology, MDM Hospital,Shashtri Nagar, Jodhpur
Dr. S. N. Medical College, Shashtri Nagar, Jodhpur (Rajasthan ) PIN - 32001
Jodhpur
RAJASTHAN
342001
India |
| Phone |
8829956509 |
| Fax |
|
| Email |
sdrao2006@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. S. N. Medical College, Shashtri Nagar, Jodhpur(Rajasthan ) PIN-32001 |
|
|
Primary Sponsor
|
| Name |
Dr S N Medical College and Associated Group of Hospitals Jodhpur Rajasthan |
| Address |
Dr. S. N. Medical College, Shashtri Nagar, Jodhpur (Rajasthan) |
| Type of Sponsor |
Government 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 |
| Dr Sukhdev Rao |
Dr. S.N. Medical College and Associated Group of Hospitals(MDM, MGH, Umaid Hospital) Jodhpur. |
Department Of Anaesthesiology, Shashtri Nagar, Jodhpur (Rajasthan)
PIN-342001
Jodhpur
RAJASTHAN |
8829956509
sdrao2006@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr Sampurnanand Medical College, Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of ASA grad 1 and 2, weight 50 -80 kg, posted for elective surgery under general anaesthesia |
|
| ExclusionCriteria |
| Details |
Patient refusal, edentulous, pregnancy, upper air way facial abnormality or pathology, tumour, midline neck swelling requiring a rapid sequence induction or awake intubation, patients with history of previous surgery, burn, radiation or trauma to upper airway, unable to stand erect, patients with various craniofacial syndromes having facial abnormality like Treacher Collins Syndrome, Klippel Feil Syndrome, Crouzon Syndrome, Apert Syndrome etc. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the sensitivity, specificity, positive predictive value and negative predictive value of ratio of patient height to thyromental distance, ratio of patient neck circumference to thyromental distance and thyromental height in adult patients. |
By December2020 |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="316"
Sample Size from India="316"
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)
|
19/12/2019 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study " A comparative study to evaluate difficulty of laryngoscopic endotracheal intubation by using ratio of patient height to thyromental distance, ratio of neck circumference to thyromental distance and thyromental height in adult patients in tertiary care centre " will be done at Dr S.N. Medical college and associated group of hospitals Jodhpur, Rajasthan. The study will be done under the guidance of my guide and the study is approved by the Institutional Ethecs Committee Dr Sampurnanand Medical College, Jodhpur. |