FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/05/024960 [Registered on: 01/05/2020] Trial Registered Prospectively
Last Modified On: 29/04/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of two types of laryngoscopes for tracheal intubation in emergency 
Scientific Title of Study   Direct vs McGrath videolaryngoscope for tracheal intubation in trauma resuscitation bay - A Randomized 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  AJITH P 
Designation  Junior resident  
Affiliation  Postgraduate institute of medical education and research  
Address  Anaesthesia office Department of anaesthesia 4th floor PGIMER Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9495244758  
Fax    
Email  ajith.porur333@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  KAJAL JAIN 
Designation  Professor 
Affiliation  Postgraduate institute of medical education and research  
Address  Department of anaesthesia Anaesthesia office 4th floor PGIMER Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9495244758  
Fax    
Email  Kajalteji@gmail.com  
 
Details of Contact Person
Public Query  
Name  AJITH P 
Designation  Junior resident 
Affiliation  Postgraduate institute of medical education and research  
Address  Department of anaesthesia Anaesthesia office 4th floor PGIMER

Chandigarh
CHANDIGARH
160012
India 
Phone  9495244758  
Fax    
Email  ajith.porur333@gmail.com  
 
Source of Monetary or Material Support  
Postgraduate institute of medical education and research, sector 12, Chandigarh 
 
Primary Sponsor  
Name  Postgraduate institute of medical education and research  
Address  PGIMER Sector12 Chandigarh  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Department of anaesthesia   4th floor Nehru hospital PGIMER Sector12 Chandigarh 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR AJITH P  Postgraduate institute of medical education and research   Department of anaesthesia Anaesthesia office 4th floor Nehru hospital Sector12 Chandigarh
Chandigarh
CHANDIGARH 		 9495244758

ajith.porur333@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S069||Unspecified intracranial injury,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Direct laryngoscope  Comparison between direct versus Mc Grath videolaryngoscope in trauma victims 
Intervention  Mc Grath Videolaryngocope  Trauma resuscitation bay presents unique challenges during securing of airways. Data on studies prospectively comparing the DL and VL in these scenarios are limited. This study is designed to compare the first pass intubation success rate, time to intubate and associated complication with McGrath VL and Macintosh DL in trauma resuscitation bay of our tertiary care hospital and research institute. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  All adult trauma victims reporting to trauma emergency and requiring definitive airway control with endotracheal intubation will be enrolled in the study which includes patients with following indications.
Cognitive impairment (GCS 8 or less)
Airway obstruction
Severe hypoxemia
Hypoventilation
Hemorrhagic shock
 
 
ExclusionCriteria 
Details  Patient having following criteria will be excluded.
Age less than 18 years.
Suspecting traumatic injury to larynx.
Extensive maxillofacial injury requiring immediate surgical intervention.
Acute traumatic spinal cord injury
Active vomiting
Pregnant
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary study endpoint will be
to compare the first-pass intubation success rate between and McGrath VL Macintosh DL in trauma resuscitation bay.
 		 Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
The time needed to perform the tracheal intubation
Incidence of hypoxemia,
haemodynamic instability, peri- intubation aspiration, airway injuries, bleeding and oesophageal intubation.
 		 baseline 
 
Target Sample Size   Total Sample Size="76"
Sample Size from India="76" 
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)   01/05/2020 
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)?  

Brief Summary  

 Trauma resuscitation bay presents unique challenges during securing of airways. Data on studies prospectively comparing the DL and VL in these scenarios are limited. This study is designed to compare the first pass intubation success rate, time to intubate and associated complication with McGrath VL and Macintosh DL in trauma resuscitation bay of our tertiary care hospital and research institute.

 
Close