| CTRI Number |
CTRI/2017/09/009917 [Registered on: 26/09/2017] Trial Registered Retrospectively |
| Last Modified On: |
14/10/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
to study the efficacy of ultrasound guided airway assessment in patients posted for general anesthesia |
|
Scientific Title of Study
|
A Study For Preoperative Assessment Of Airway By Ultrasonography Imaging At Point Of Care In Patients For General Anesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vishal Koundal |
| Designation |
Junior Resident |
| Affiliation |
Dr. RPGMC Kangra at Tanda |
| Address |
Department of Anesthesia, Dr. RPGMC Kangra at Tanda
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9805797607 |
| Fax |
|
| Email |
vishalkoundal174@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shelly Rana |
| Designation |
Professor |
| Affiliation |
Dr. RPGMC Kangra at Tanda |
| Address |
Department of Anesthesia, Dr. RPGMC Kangra at Tanda
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418113786 |
| Fax |
|
| Email |
shelkbj@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vishal Koundal |
| Designation |
Junior Resident |
| Affiliation |
Dr. RPGMC Kangra at Tanda |
| Address |
Department of Anesthesia, Dr. RPGMC Kangra at Tanda
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9805797607 |
| Fax |
|
| Email |
vishalkoundal174@gmail.com |
|
|
Source of Monetary or Material Support
|
| Health And Family Welfare Department, Himachal Pradesh |
|
|
Primary Sponsor
|
| Name |
Dr Rajendra Prasad Government Medical College |
| Address |
Department of Anaesthesia Dr Rajendra Prasad Government Medical College Tanda Kangra Himachal Pradesh 176001 |
| 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 Vishal Koundal |
Dr. RPGMC Kangra at Tanda |
Department of Anesthesia, 3rd floor
Kangra
HIMACHAL PRADESH |
9805797607
vishalkoundal174@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. RP Government Medical College Kangra at Tanda Himachal Pradesh, India-176001 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
All ASA 1/2 Patients Posted for Surgery Under General Anesthesia , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Sonosite Micromaxx ultrasound system |
Sonosite INC Bothell WA
high frequency linear probe and low frequency curved probe |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical class 1 and 2.
BMI 18.5-29.9 |
|
| ExclusionCriteria |
| Details |
1. Patient’s refusal to participate in the study.
2. Rapid-sequence induction of anesthesia. Patients requiring rapid-sequence intubation are already at high risk for aspiration; the airway should be rapidly secured with an endotracheal tube and not subjected to repeated or delayed assessment as might occur in the study.
3. Inability to open the mouth due to existing trauma or medical condition, preexisting neck or facial disease causing distortion of the airway, edentulous, and/or a history of difficult intubation.
4. Altered level of consciousness, confusion, or inability to follow commands
5. Preexisting limitation or pain with cervical spine movement.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.to observe relation between HM distance ratio and ease of laryngoscopy.
2.to determine utility of measurement of thickness of anterior neck soft tissue at the level of hyoid bone,thyrohyoid membrane in distinguishing difficult and easy laryngoscopies.
3.to study correlation between sonographic modification of CL Scoring with actual CL grading during direct laryngoscopy.
4.temporal comparison of real time ultrasound vs capnography and auscultation in confirmation of endotracheal placement. |
March 2016-June 2017 |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
30/03/2016 |
| 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) |
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
Modification(s)
|
in this study we will determine the feasibility of ultrasound in preoperative airway assessment and we will determine the feasibility of ultrasound in predicting difficult airway. |