CTRI Number |
CTRI/2017/06/008940 [Registered on: 29/06/2017] Trial Registered Retrospectively |
Last Modified On: |
29/06/2017 |
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 Airtraq and Kingvision videolaryngoscope for intubation in adults. |
Scientific Title of Study
|
A comparative evaluation of two videolaryngoscopes (The Airtraq and Kingvision) as an intubating aid in adult patients. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Devyani Desai |
Designation |
Associate Professor |
Affiliation |
Govt Medical college Vadodara |
Address |
22-Soham Bunglows-1
Behind Palm view apt
Vasna Road
Vadodara Dept of Anaesthesiology
S S G Hospital
Govt Medical college
Vadodara Vadodara GUJARAT 390007 India |
Phone |
9909983168 |
Fax |
|
Email |
devyani.dr@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Devyani Desai |
Designation |
Associate Professor |
Affiliation |
Govt Medical college Vadodara |
Address |
22-Soham Bunglows-1
Behind Palm view apt
Vasna Road
Vadodara Dept of Anaesthesiology
S S G Hospital
Govt Medical college
Vadodara Vadodara GUJARAT 390007 India |
Phone |
9909983168 |
Fax |
|
Email |
devyani.dr@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Shweta |
Designation |
2nd year resident |
Affiliation |
Govt Medical college Vadodara |
Address |
Room No6
New PG2 medical hostel
Opposite Kuberbhavan
Near Kothi char rasta
Vadodara Govt Medical College
S S G Hospital
Vadodara Vadodara GUJARAT 390001 India |
Phone |
9408723517 |
Fax |
|
Email |
drshweta2309@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
S S G Hospital |
Address |
Jail road, Vadodara, Gujarat |
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 Devyani Desai |
Govt Medical College, Vadodara, Gujarat |
Department of general surgery, ENT, Gynaecology and Plastic surgery
C1,C2,C3.C4,D1,D2,D3,D4,ENT RR,E1,10
S S G Hosp, Vadodara, Gujarat
 Vadodara GUJARAT |
9909983168
devyani.dr@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee for Human Research, Medical College, Vadodara |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Age:18-60 yrs.
Weight: 40-70kg of either sex.
Mallampatti grade I & II
Mouth opening 20mm
ASA I & II
Posted for elective surgeries under general anaesthesia and intubation, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Airtraq videolaryngoscope |
After inducing the patient with Inj Propofol and proper relaxation with Inj Succinyl Choline, endotracheal intubation was done using Airtraq videolayngoscope |
Intervention |
Kingvision videolaryngoscope |
After inducing the patient with Inj Propofol and proper relaxation with Inj Succinyl Choline, endotracheal intubation was done using Kingvision videolayngoscope |
Comparator Agent |
NIL |
NIL |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Patient willing to participate in study group.
Patients posted for elective surgery requiring general anesthesia and Endotracheal Intubation for planned surgery.
Age:18-60 yrs.
Weight: 40-70kg of either sex.
Mallampatti grade I & II
Mouth opening >20mm
ASA I & II
|
|
ExclusionCriteria |
Details |
Cervical spine disorder
Thyromental distance less than 6cm
Stern mental distance less than 12 cm
Neck circumference more than 42cm
Obesity (BMI ≥ 30)
Pregnant patients
Known case of GERD
Oropharyngeal pathology
Emergency surgeries
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
To compare Airtraq and King vision in terms of following parameters-
1. Time of video laryngoscopy: Time taken from introduction of Video laryngoscope to view of glottis. (T1)
2. Time of tube insertion: Time taken from view of glottis to insertion of endotracheal tube and confirmation by CAPNOGRAPHY. (T2)
3. Total duration of intubation (T1+T2)
4. No. of attempts of Video laryngoscope insertion
5. Quality of visualization of Glottic aperture
|
Time of videolaryngoscopy. tube insertion and intubation in Seconds
Vitals at 0,5,10 and 15 min |
|
Secondary Outcome
|
Outcome |
TimePoints |
1. Optimization maneuvers required for intubation
2. Vital parameters
3. Incidence of airway trauma and complications.
|
Score - 0,1,2,3
Baseline, 5, 10, 15 and postopratively |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
01/06/2017 |
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="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
Yet to be done and then published |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
This randomized controlled trial will be carried out in SSG hosp during a period of one year after march 2017. We will be enrolling 30 patients in each group after getting the sample size estimation using n master statistical software considering alpha error 0.05, confidence interval 95% and power 80%. After through preanaesthetic check up and informed written consent, patient will taken inside the operation theatre and multipara monitor will be attached. Preoperative vitals will be checked. In case of Airtraq videolaryngoscope, the CMOS camera will be mounted on it and checked by watching the image on the monitor.In case of Kingvision videolaryngoscope,blade will be mounted and checked by pushing the on button and checking the image on the monitor. For both the devices, the tube to be used will be lubricated with Lignocaine jelly and the respective device will be preloaded with 7.5 in case of females and 8.5 in case of males. All patients will be premedicated with Inj Glycopyrolate 0.2mg intramuscularly 30 mins before and Inj Fentanyl 2mcg/kg intravenously 5mins before induction. After inducing the patient with Inj Propofol 2mg/kg and getting proper muscle relaxation with Inj Succinyl Choline 2mg/kg, patient will be intubated using either of the device in neutral head position. The study population will be randomly allocated to two groups : Group A in whon Airtraq and Group K in whom will be used. Videolaryngoscopy time, Tube insertion time, Total duration of intubation, Number of attempts, Optimization manoeuvers required, Quality of glottis aperture, Vital parameters and Incidences of airway trauma will be recorded. Data will be tabulated and presented in mean and SD form and p value <0.05 will be considered significant.
|