| CTRI Number |
CTRI/2018/03/012378 [Registered on: 06/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
27/02/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between two Video Laryngoscope |
|
Scientific Title of Study
|
A Prospective Randomized Study To Compare King Vision Video Laryngoscope And McGrath Video Laryngoscope In Adults Patients Undergoing Laparoscopic Cholecystectomy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohammad Ahmad Khan |
| Designation |
Junior Resident |
| Affiliation |
JNMCH AMU ALIGARH |
| Address |
C12 Second Floor Rifa Palace
Infront Of Green Crescent School
Medical Road Aligarh
AMU Aligarh
Aligarh UTTAR PRADESH 202002 India |
| Phone |
9457665723 |
| Fax |
|
| Email |
ahmadkhn43@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Syed Hussain Amir |
| Designation |
Assistant Professor |
| Affiliation |
JNMCH AMU ALIGARH |
| Address |
Department of Anaesthesia
Jawaharlal Nehru Medical College
AMU,Aligarh
Aligarh UTTAR PRADESH 202002 India |
| Phone |
8218496722 |
| Fax |
|
| Email |
hussainamir77@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Mohammad Ahmad Khan |
| Designation |
Junior Resident |
| Affiliation |
JNMCH AMU ALIGARH |
| Address |
C12 Second Floor Rifa Palace
Infront Of Green Crescent School
Medical Road Aligarh
AMU Aligarh
Aligarh UTTAR PRADESH 202002 India |
| Phone |
9457665723 |
| Fax |
|
| Email |
ahmadkhn43@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College
AMU,Aligarh |
|
|
Primary Sponsor
|
| Name |
Department Of Anaesthesiology |
| Address |
Department of Anaesthesiology and Critical Care
Jawaharlal Nehru Medical College
Aligarh Muslim University, Aligarh |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Qazi Ehsan Ali |
Professor
Department of Anaesthesiology and Critical Care
Jawaharlal Nehru Medical College
Aligarh Muslim University, Aligarh |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Mohammad Ahmad Khan |
Jawaharlal Nehru Medical College AMU Aligarh |
Department of Anaesthesiology and Critical Care
Jawaharlal Nehru Medical College
Aligarh Muslim University Aligarh UTTAR PRADESH |
9457665723
ahmadkhn43@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Faculty of Medicine, AMU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ASA Physical Status
I and II, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
King Vision Video laryngoscope and McGrath Video laryngoscope |
Intubation time comparison |
| Comparator Agent |
McGrath Video laryngoscope |
Intubation time comparison |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade I and II
Weight between 40-70 Kg
Patients planned for Elective Laparoscopic Cholecystectomy |
|
| ExclusionCriteria |
| Details |
Previous history of multiple/ failed intubation.
Head and neck surgery.
Valvular heart disease.
CAD / Uncontrolled hypertension.
Presence of raised intracranial pressure.
Cervical spine injury.
Previous history of multiple/ failed intubation.
Head and neck surgery.
Valvular heart disease.
CAD / Uncontrolled hypertension.
Presence of raised intracranial pressure.
Cervical spine injury.
Predicted difficult laryngoscopy except for all class of MP Grades
Any pathology of the oral cavity that will obstruct the insertion of device.
Mouth opening <2.5cm.
Potentially full stomach patients (trauma, morbid obesity, pregnancy, history of gastric regurgitation and heart burn) and at risk of esophageal reflux (hiatus hernia).
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the laryngoscopy & intubation time using the two devices.
To compare the glottic view using POGO (percentage of glottic opening) score.
To compare the hemodynamic response i.e., heart rate and mean arterial B.P. after laryngoscopy and intubation.
To compare the success of laryngoscopy & intubation in all classes of Mallampati grading.
|
Two years from start of study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To grade the ease of tracheal intubation using these devices.
To compare the number of adjustment maneuvers required for successful intubation.
To look for post operative complications if any. |
2 yrs |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/03/2016 |
| Date of Study Completion (India) |
10/12/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study entitled “A Prospective Randomized Study To Compare King Vision Video Laryngoscope And McGrath
Video Laryngoscope In Adult Patients Undergoing Laparoscopic Cholecystectomy†was
performed to compare the two different laryngoscopes. 60 ASA physical status I and II
of either sex (20-60 yrs. of age) undergoing general anaesthesia for elective
laparoscopic cholecystectomy surgery were included in the study. Patients with
all MP class were included. After obtaining approval from Board of studies
Department of Anaesthesiology and Institutional ethical committee, patients
were randomly divided into two groups. Patients of KV Group [N=30] were
intubated using King Vision video laryngoscope and patients of MV Group [N=30]
were intubated using McGrath video laryngoscope. Blinding of the attending
laryngoscopists was not possible as the two laryngoscopes were markedly
different.
All patients in the both groups
were monitored using all standard
monitors; female patients were intubated with 7.0 mm PVC ETT (endotracheal
tube) whereas male patients were intubated with 8.0 mm PVC ETT
The King Vision VLs and McGrath
VLs were compared with each other with respect to
laryngoscopy and intubation time, changes in heart rate and blood pressure
after intubation at different interval of time, number of attempts for
successful intubation, number of adjustment maneuvers, ease of tracheal
intubation and post extubation complications.
Of all the patients who were
intubated; 93.33% of the patients were intubated in single attempt with King
Vision VLs as compared to 70% with McGrath VLs. However second attempts
intubation rate was 100% both in King Vision VLs and McGrath VLs. Among the two
instruments none had taken more than two attempts for successful
intubation.
The King Vision VLs did required
less adjustment maneuvers as compared to McGrath VLs. 10% and 46.66% patients
required more than two adjustment maneuvers in King Vision VLs and McGrath VLs
respectively.
The incidence of ease of
intubation grade 1 with King Vision VLs and McGrath VLs was 90% and 63.33%
respectively. However 10% and 36.66% patients had grade II ease of intubation
in King Vision VLs and McGrath VLs respectively. Among the two instrument none
had shown a failed intubation.
The mean intubation time was
12.56 second and 22.2 seconds in King Vision VLs and McGrath VLs respectively.
McGrath VLs required more time than King Vision VLs to intubate the patients.
In both groups; there was a
significant rise in heart rate from pre induction value to immediate post
intubation, 3 and 5 minute of post intubation but came down near to pre
induction value within 10 minutes of intubation. In inter group comparison
between two groups at a time, variation in heart rate did show statistically
significant rise with McGrath VLs as compared to King Vision VLs during 3 min
post intubation.
Both groups showed significant
change in MABP at post intubation period, although comparatively lesser in KV
group. Rise in MABP was statistically significant at immediate post intubation
and 3 minute post intubation time.
The incidence of complications
like sore throat, blood staining on ETT and hoarseness after extubation was
less in KV group as compared to MV group.
|