| CTRI Number |
CTRI/2021/11/037712 [Registered on: 01/11/2021] Trial Registered Prospectively |
| Last Modified On: |
30/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two techniques of anaesthesia. |
|
Scientific Title of Study
|
A comparison of Glidescope and
KingsVision guided endotracheal intubation in patients with simulated difficult airway- A randomised control trial
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Neeharika arora |
| Designation |
Professor |
| Affiliation |
Rohilkhand medical college and hospital. |
| Address |
Department of anesthesiology, Rohilkhand medical college and hospital, pilibhit bypass road.
Department of anesthesiology, Rohilkhand medical college and hospital pilibhit bypass road barielly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
7888751369 |
| Fax |
|
| Email |
docneehars@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neeharika arora |
| Designation |
Professor |
| Affiliation |
Rohilkhand medical college and hospital. |
| Address |
Department of anesthesiology, Rohilkhand medical college and hospital, pilibhit bypass road.
Department of anesthesiology, Rohilkhand medical college and hospital pilibhit bypass road barielly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
7888751369 |
| Fax |
|
| Email |
docneehars@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neeharika arora |
| Designation |
Professor |
| Affiliation |
Rohilkhand medical college and hospital. |
| Address |
Department of anesthesiology, Rohilkhand medical college and hospital, pilibhit bypass road.
Department of anesthesiology, Rohilkhand medical college and hospital pilibhit bypass road barielly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
7888751369 |
| Fax |
|
| Email |
docneehars@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rohilkhand medical college and hospital bareilly. |
|
|
Primary Sponsor
|
| Name |
Rohilkhand medical college and hospital |
| Address |
Suresh sharma nagar , pilibhit bypass road barielly. |
| 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 |
| Dilpreet singh |
Ot complex. room no 2062 .Department of anesthesiology |
Rohilkhand medical college and hospital pilibhit bypass road barielly.
Bareilly
UTTAR PRADESH |
7888751369
dilpreetraina19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, Rohilkhand medical college and hospital,bareilly. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Glidescope video laryngoscope. |
It is a video laryngoscope system with seperate display screen duration for 10 seconds to 10 minutes |
| Intervention |
Kingsvision video laryngoscope. |
It is a video laryngoscope system duration for 10 sec to 10 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.American society of Anesthesiologist (ASA) grade I or II
2.Between 18-60 years of either sex 11,12
3.Posted for elective surgery of different specialties
|
|
| ExclusionCriteria |
| Details |
1.Anticipated difficult airway- Mallampatti grade ≥ III , Thyromental distance < 6cm , inter incisor distance < 3.5cm , History of difficult airway management in past.
2.Emergency surgery.
3.Full stomach.
4.Cardiovascular diseases and uncontrolled hypertension.
5.High intra cranial pressure (ICP).
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ease of intubation |
From time of intubation till 12 hours . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post operative sore throat. |
From time of intubation till 24 hrs . |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
30/11/2021 |
| 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)?
Response - NO
|
|
Brief Summary
|
The experience and expertise of an anesthesiologist in management of airway plays a vital role in both emergency as well as elective cases to maintain paramount oxygenation and prevent any undesirable results. Inability to secure an airway efficiently has been considered as most common cause of fatality due to anesthesia.A variety of new video laryngoscopes have been introduced to facilitate endotracheal intubation thus making it more difficult to choose. However inability to extend cervical spine remains the most common indication for use of video laryngoscopes. There are very few studies in this region on Kingsvision video laryngoscope and Glidescope in which all the aspects are assessed regarding these to video laryngoscopic devices. The purpose of this study is to compare the efficacy and success rate, visualization of glottic structure, ease of intubation with Kingsvision video laryngoscope system to GlideScope in patient with simulated difficult airway.
|