| CTRI Number |
CTRI/2017/05/008541 [Registered on: 12/05/2017] Trial Registered Prospectively |
| Last Modified On: |
15/04/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study using ultra sound scanning of neck and tongue to find the difficulty in placing artificial tube in the wind pipe in patients undergoing anaesthesia |
|
Scientific Title of Study
|
Ultrasound Measurement of Anterior Neck Soft Tissue and tongue thickness to predict difficult laryngoscopy- An observational analytical 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 Nabin Krishna Yadav |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Institute Of Postgraduate Medical Education and Research |
| Address |
Room no-409,Harvey-2,Hostel Complex,Jawaharlal Institute Of Postgraduate Medical Education and Research, Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9677466793 |
| Fax |
|
| Email |
korgiya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priya Rudingwa |
| Designation |
Assistant professor, |
| Affiliation |
Jawaharlal Institute Of Postgraduate Medical Education and Research |
| Address |
Department of Anesthesiology and Critical care,Jawaharlal Institute Of Postgraduate Medical Education and Research,
(JIPMER),Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8903477132 |
| Fax |
|
| Email |
priyaab8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priya Rudingwa |
| Designation |
Assistant professor, |
| Affiliation |
Jawaharlal Institute Of Postgraduate Medical Education and Research |
| Address |
Department of Anesthesiology and Critical care,Jawaharlal Institute Of Postgraduate Medical Education and Research,
(JIPMER),Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8903477132 |
| Fax |
|
| Email |
priyaab8@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, second floor, Hospital block,Jawaharlal Institute Of Postgraduate Medical Education & Research, Dhanvantry nagar Puducherry-605006 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute Of Postgraduate Medical Education and Research |
| Address |
Dhanvantry nagar, JIPMER,Puducherry-605006 |
| 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 Nabin Krishna Yadav |
Jawaharlal Institute Of Postgraduate Medical Education and Research,JIPMER |
Department of Anaesthesiology, Jawaharlal Institute Of Postgraduate Medical Education and Research,Dhanvantry nagar, Puducherry-605006
Pondicherry
PONDICHERRY |
9677466793
korgiya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jawaharlal Institute Of Postgraduate Medical Education & Research, Puducherry-605006 Institute ethics committee (human studies) ECR/687/Jipmer/Inst/PY/2013 dated 23 May 2013) |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Difficult laryngoscopy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ultrsound parameters :
1. distance from skin to hyoid bone
2. distance from skin to thyrohyoid membrane
3. maximum tongue thickness |
Clinical screening tests :
1. Modified mallampati score
2. Thromental distance
3. sternomental distance
4. Neck circumference at level of thyroid cartilage |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.American society of Anaesthesiology physical status classification 1and 2 (ASA 1 & 2)
2.Patients in the age group of 18-70 years
3.Patients undergoing surgery under general anesthesia with endotracheal intubation |
|
| ExclusionCriteria |
| Details |
1.Patients with facial fractures, cervical spine injury or with tracheostomy tube.
2.Patients in whom rapid sequence induction is indicated.
3.Patients with poor submandibular space compliance.
4.Patients in whom direct laryngoscopy with muscle relaxants is not planned.
5.patients with neck extension < 30 degree
6.patients who cannot prognath lower incisor beyond the upper incisor
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cormack Lehane laryngoscopy grading will be assessed and Grade 3 and grade 4 will be categorized as difficult intubation (outcome) |
Cormack lehane grading of laryngeal view will be assessed at the time of laryngoscopy after administration of general anaesthesia at operation room. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the ultrasound guided measurement of anterior soft tissue neck and tongue thickness with conventional screening test to predict difficult laryngoscopy |
Cormack Lehane grading of laryngeal view will be assesed during laryngoscopy after administration of anaesthesia and grade 3 and 4 will be considered as difficult intubation |
|
|
Target Sample Size
|
Total Sample Size="310"
Sample Size from India="310"
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)
|
10/07/2017 |
| 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="1"
Months="6"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is
observational analytical study to determine the utility
of ultrasound measurement of the anterior neck soft tissue thickness at hyoid
and thyrohyoid level and Tongue thickness in predicting difficult and easy
laryngoscopy.
Conventional
clinical screening tests like MMP, inter incisor gap, thyromental distance, sternomental
distance will measured during preoperative assessment. Ultrasound
measurement of the anterior neck soft tissue thickness at hyoid and thyrohyoid
level and Tongue thickness will be measured on the day of surgery before
induction of anesthesia in supine and sniffing position in operation theatre. Direct
laryngoscopy will be performed. Ultrasound guided measurements will be compared
with conventional clinical screening tests to predict difficult laryngoscopy. |