| CTRI Number |
CTRI/2017/08/009332 [Registered on: 10/08/2017] Trial Registered Prospectively |
| Last Modified On: |
10/08/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
How to pick the causes of difficult intubation using ultrasound. |
|
Scientific Title of Study
|
Evaluation of predictors of difficult airway using ultrasound |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shalini Sharma |
| Designation |
Assistant Professor |
| Affiliation |
Dr Rajendra Prasad Govt. Medical College, Tanda |
| Address |
Deptt. of Anaesthesia;Dr Rajendra Prasad Govt. Medical College, Tanda
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418011121 |
| Fax |
|
| Email |
shalini.medico@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shalini Sharma |
| Designation |
Assistant Professor |
| Affiliation |
Dr Rajendra Prasad Govt. Medical College, Tanda |
| Address |
Deptt. of Anaesthesia;Dr Rajendra Prasad Govt. Medical College, Tanda
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418011121 |
| Fax |
|
| Email |
shalini.medico@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shalini Sharma |
| Designation |
Assistant Professor |
| Affiliation |
Dr Rajendra Prasad Govt. Medical College, Tanda |
| Address |
Deptt. of Anaesthesia;Dr Rajendra Prasad Govt. Medical College, Tanda
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418011121 |
| Fax |
|
| Email |
shalini.medico@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Rajendra Prasad Govt. Medical College, Tanda |
|
|
Primary Sponsor
|
| Name |
Shalini Sharma |
| Address |
Deptt. of Anaesthesia;
Dr Rajendra Prasad Govt. Medical College, Tanda |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Shalini Sharma |
Dr Rajendra Prasad Govt. Medical College, Tanda |
Deptt. of Anaesthesia
Kangra
HIMACHAL PRADESH |
9418011121
shalini.medico@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 |
All patients for surgery under general anaesthesia requiring intubation., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Ultrasound |
A SonoSite® MicroMaxx® ultrasound system (SonoSite INC, Bothell, WA). Low frequency curvilinear probe will be used to assess tongue parameters and hyomental distance. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients posted for surgery under general anaesthesia requiring endotrachael intubation. |
|
| ExclusionCriteria |
| Details |
1) Refusal to participate in the study
2) Patients posted for emergency surgical procedures.
3) Patients with difficulty in mouth opening eg. temporomandibular joint ankylosis.
4) Patients with obvious airway or neck pathology.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)To see whether ratio of volume of tongue to hyomental distance(HMD) in neutral position, hyomental distance in extension (HMDE) as measured by ultrasound(USG) can predict difficult intubation.
2) To observe the predictability of the ratio of tongue thickness and HMD and HMDE measured by USG for difficult intubation.
|
Airway assessment clinically and via ultrasound will be done in the pre operative area. Cormack and Lehane grading will be done during intubation.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To see whether the addition of HMDR further increases the efficacy. |
Airway assessment clinically and via ultrasound will be done in the pre operative area. Cormack and Lehane grading will be done during intubation.
|
|
|
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)
|
14/08/2017 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The present study will be conducted in the department of Anaesthesia at Dr Rajendra Prasad Govt Medical College Tanda. All
the patients will have full airway assessment during the preanaesthetic checkup ie mouth
opening ,modified mallampati scoring ,thyromental distance ,neck movements. The
patients not meeting inclusion criteria will be excluded from study and the
enrolled patients will undergo sonographic assessment of airway by the
anesthesiologist in
the pre-operative holding area. The ultrasound view of the airway of all study
patients will be assessed either with a
high frequency linear probe (A SonoSite® MicroMaxx® ultrasound system (SonoSite
INC, Bothell, WA) or a low frequency curvilinear probe. Various parameters assessed clinically will be corelated with cormack and lehane grading during intubation. |