| CTRI Number |
CTRI/2018/02/011728 [Registered on: 06/02/2018] Trial Registered Prospectively |
| Last Modified On: |
05/02/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To correlate position of larynx seen under ultrasound machine and seen with help of direct laryngoscopy |
|
Scientific Title of Study
|
Comparison of laryngeal position using ultrasound imaging vs direct laryngoscopy in neutral and sniffing position |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr pranjali Kurhekar |
| Designation |
Professor |
| Affiliation |
Shri sathya sai medical college and research institute. |
| Address |
Department of Anesthesiology
Shri Sathya Sai Medical College and Research Institute,
Tiruporur Gudanvanchery main road,
Ammapettai, Kancheepuram.
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
044-27440700 |
| Fax |
044-27440138 |
| Email |
pranjalikurhekar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pranjali Kurhekar |
| Designation |
Professor |
| Affiliation |
Shri sathya sai medical college and research institute. |
| Address |
Department of Anesthesiology
Shri Sathya Sai Medical College and Research Institute,
Tiruporur Gudanvanchery main road,
Ammapettai, Kancheepuram.
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
044-27440700 |
| Fax |
044-27440138 |
| Email |
pranjalikurhekar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr pranjali Kurhekar |
| Designation |
Professor |
| Affiliation |
Shri sathya sai medical college and research institute. |
| Address |
Department of Anesthesiology
Shri Sathya Sai Medical College and Research Institute,
Tiruporur Gudanvanchery main road,
Ammapettai, Kancheepuram.
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
044-27440700 |
| Fax |
044-27440138 |
| Email |
pranjalikurhekar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Sathya Sai Medical College and Research Institute, Tiruporur Guduvanchery main road,Ammapettai,Kancheepuram
Tamilnadu 603108 |
|
|
Primary Sponsor
|
| Name |
Shri sathya Sai medical college |
| Address |
Tiruporur Guduvanchery main road, Ammapettai,
Kancheepuram, Tamilnadu. |
| Type of Sponsor |
Private 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 Pranjali Kurhekar |
Shri Sathya Sai Medical College and Hospital |
II floor operation theatre complex, department of Anaesthesiology
Kancheepuram
TAMIL NADU |
9486414942
044-27440138
pranjalikurhekar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Posted for elective surgery under general anaesthesia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Willingness to participate in the study
2.ASA I or II physical status
3.Surgeries under general anesthesia requiring endotracheal intubation
|
|
| ExclusionCriteria |
| Details |
1.ASA III or above
2.Mouth opening less than 2 finger breadth
3.Temporo mandibular joint stiffness
4.Ankylosing spondylosis
5.Submucosal fibrosis
6.Pregnancy
7.Buck tooth
8.Any cervical spine pathology
9.Infections of airway
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To correlate position of larynx on ultrasound with direct laryngoscopy in sniffing position and neutral position |
Ultrasonography before starting of anaesthesia
Cormack Lehane grading at laryngoscopy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To correlate Cormack Lehane grading with mentohyoid distance and anterior neck soft tissue thickness on ultrasound in both positions. |
Ultrasonography before starting of anaesthesia
Cormack Lehane grading at laryngoscopy |
|
|
Target Sample Size
|
Total Sample Size="215"
Sample Size from India="215"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
19/02/2018 |
| 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="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study protocol will be explained to the patients and informed consent will be obtained. Ultrasound examination of upper airway will be done in sniffing and neutral position. Hyomental distance will be measured. Anterior neck soft tissue thickness will be seen at level of vocal cords. The transverse processes of cervical vertebrae corresponding to the vocal cords will be noted. That will be taken as laryngeal position. After shifting the patient to the OT standard protocol for induction of anaesthesia will be followed. Muscle relaxation will be achieved with inj vecuronium in all patients. Laryngoscopy will be done with Macintosh blade,size 3 in female patients and size 4 in male patients. Laryngoscopy will be done first in neutral position and modified Cormack Lehane grading (CML) will be noted. If CML is more than I then backward upwards rightwards pressure (BURP) will be applied and if there is change in CML due to BURP will be noted. Same procedure will be repeated in sniffing position. After confirming the CML with BURP, trachea will be intubated with appropriate size entotracheal tube. Capnographic confirmation of entotracheal intubation will be end point of study. Inability to visualize vocal cords after optimal sniffing position with BURP will be manage according to difficult airway management protocol and findings will be noted. |