| CTRI Number |
CTRI/2019/12/022303 [Registered on: 11/12/2019] Trial Registered Prospectively |
| Last Modified On: |
03/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of videolaryngoscope with normal laryngoscope for intubation in clinically normal population. |
|
Scientific Title of Study
|
Comparison of MacGrath Videolaryngoscope with conventional Macintosh laryngosope for endotracheal intubation in adult population - a randomized controlled 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 Swati Bhatt |
| Designation |
professor |
| Affiliation |
SSG Medical College and Hospital, Baroda |
| Address |
Department of Anaesthesia
medical college baroda, vinoda bhavan road, anandpura,vadodara
Vadodara
GUJARAT
390001
India |
| Phone |
9428603196 |
| Fax |
|
| Email |
drswatibhatt2015@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swati Bhatt |
| Designation |
professor |
| Affiliation |
SSG Medical College and Hospital, Baroda |
| Address |
Department of Anaesthesia
medical college baroda, vinoda bhavan road, anandpura,vadodara
Vadodara
GUJARAT
390001
India |
| Phone |
9428603196 |
| Fax |
|
| Email |
drswatibhatt2015@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swati Bhatt |
| Designation |
professor |
| Affiliation |
SSG Medical College and Hospital, Baroda |
| Address |
Department of Anaesthesia
medical college baroda, vinoda bhavan road, anandpura,vadodara
Vadodara
GUJARAT
390001
India |
| Phone |
9428603196 |
| Fax |
|
| Email |
drswatibhatt2015@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SSG hospital |
| Address |
Department of Anaesthesia, Baroda medical college, vinoda bhavan road, Anandpura, Vadodara |
| 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 Sneha Bhavsar |
SSG hospital, vadodara |
Department of anaesthesia, new surgical block, Baroda medical college,
vinoda bhavan road, anandpura,
Vadodara
GUJARAT |
9428603196
sbhavsar124@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IECHR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H664||Suppurative otitis media, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
endotracheal intubation |
endotracheal intubation with the use of Macintosh laryngoscope |
| Intervention |
Macgrath videolaryngoscope |
Endotracheal intubation with macgrath videolaryngoscope |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patient posted for elective surgery requiring endotracheal intubation
asa 1 and 2
mouth opening more than or equal to 5 and mallampati grade 1 and 2. |
|
| ExclusionCriteria |
| Details |
patient not willing for participation
patient with difficult intubation
abnormal airway anatomy
obesity(BMI more than 30kg/m2)
pregnancy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Intubation time |
at time of intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| glottic view time |
at time of intubation |
| cormack lehane grading |
grade 1 to 4
at time of intubation |
| number of attempts |
at time of intubation |
| optimization maneuvers |
at the time of intubation |
| vital parameters |
baseline, at time of intubation, 1 min , 5 min and 10 mins after intubation |
| complications |
desaturation, trauma, sore throat, spasm |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
11/12/2019 |
| 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
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
intubation time and glottic view time would be shorter, less trauma , faster intubation and more vital stability along with overall sucess rate would be more with Macgrath videolaryngoscope as compared to macintosh laryngoscope. |