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CTRI Number  CTRI/2024/05/066825 [Registered on: 06/05/2024] Trial Registered Prospectively
Last Modified On: 03/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparision of Airtraq TM video laryngoscope with Macintosh laryngoscope for emergency intubation 
Scientific Title of Study   Comparison of AirtraqTM videolaryngoscope with Macintosh laryngoscope for emergency endotracheal intubation: A randomized controlled study 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Abhimanyu Kumar Singh 
Designation  Post graduate student 
Affiliation  University College of Medical Sciences/Guru Tegh Bahadur Hospital 
Address  Department of Anaesthesia UCMS/GTBH Dilshad Garden/GTB hospital Second Floor Room no 221

East
DELHI
110095
India 
Phone  8578883777  
Fax    
Email  drsinghuc@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr RS Rautela 
Designation  Director Professor Anaesthesia 
Affiliation  University College of Medical Sciences/Guru Tegh Bahadur Hospital 
Address  Depart of anesthesia UCMS/GTBH Dilshad Garden/GTB hospital

East
DELHI
110095
India 
Phone  8578883777  
Fax    
Email  rsramb@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Abhimanyu Kumar Singh 
Designation  Post graduate student 
Affiliation  University College of Medical Sciences/Guru Tegh Bahadur Hospital 
Address  Department of Aesthesia UCMS/GTBH Dilshad Garden/GTB hospital

East
DELHI
110095
India 
Phone  8578883777  
Fax    
Email  drsinghuc@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  University College Of Medical Sciences 
Address  Dilhad Garden, Delhi Shahara, 110002  
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Michell Gulabani  University College of Medical Sciences/Guru Tegh Bahadur Hospital  Emergency department/ wards GTB Hospital Dilshad Garden/GTB hospital 110002
East
DELHI 		 09873657500

michellgulabani@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee- Human Research, University College of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J960||Acute respiratory failure, (2) ICD-10 Condition: O||Medical and Surgical, (3) ICD-10 Condition: R098||Other specified symptoms and signsinvolving the circulatory and respiratory systems,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Airtraq group  The trachea of all patients in this group will be intubated using Airtarq TM laryngoscope 
Comparator Agent  Group M- The trachea of all patients in this group will be intubated using Macintosh direct laryngoscope  A brief examination of the patient’s vital signs, Glasgow coma scale and peripheral oxygen saturation by a pulse oximeter will be done and recorded. A quick airway examination for obvious deformities including factors like cervical mobility restriction (intrinsic or cervical collar), obesity, short neck, receding mandible, facial or neck trauma, blood or vomit in the airway will be done. Simultaneously, the team will ensure adequate availability of all necessary equipment for endotracheal intubation which will be performed as Modified Rapid sequence intubation. Pre-requisites for intubation: • Suction — at least one working suction, will be placed between mattress and bed • Oxygen — Non rebreathing mask an bag and mask ventilation attached to 15 litres per minute of oxygen Airways, 7.5 mm ID endotracheal tube most adults, 7.0 for smaller females and 8.0 mm ID for larger males. The type of laryngoscope either Airtraq TM or Macintosh depending on the group to which the patient will belong. Pre-oxygenate with 100% oxygen with 15 litres per minute. Medications: All hypnotic agents with or with neuromuscular blocking agents will be given in clinically appropriate doses as per the patient’s haemodynamic status. The time to successful intubation will be recorded. The other parameters recorded will be first pass success rate of endotracheal intubation, Cormack Lehane grade of assessment of the glottis, number of attempts of intubation, ease of intubation with either device, facilitating maneuvers like optimal external laryngeal manipulation or using a stylet for endotracheal intubation, esophageal intubation, failed intubation and dental trauma. For these parameters, blinding will not be ensured. Edit || Delete  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Adult patients between the ages of 18-70 years requiring emergency endotracheal intubation in the hospital premises by a team of anaesthesiologists 
 
ExclusionCriteria 
Details  Endotracheal intubations performed in the operating room
Endotracheal intubations performed in the intensive care unit
Patients in whom surgical airway will be required as the first option to secure a definite airway
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To study and compare the time to intubation between Airtraq TM video laryngoscope and direct Macintosh laryngoscope  The time of intubation  
 
Secondary Outcome  
Outcome  TimePoints 
To compare the first pass intubation success rates between Airtraq TM & Macintosh laryngoscope.
Comparison of the Cormack- Lehane assessment for the glottis view by both the Airtraq TM videolaryngoscope & Macintosh laryngoscope.
To compare the number of attempts for successful endotracheal intubation with both Airtraq TM & Macintosh laryngoscope.
To compare the ease of intubation with either device using a three point scoring system of good, satisfactory & poor
To compare the incidence of esophageal intubation, failed intubation & dental trauma amongst the two laryngoscopes.
 		 At the single point of intubation 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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 4 
Date of First Enrollment (India)   30/05/2024 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Study title: Evaluation of Airtraq TM video laryngoscope with Macintosh laryngoscope for emergency endotracheal intubation in adult patients: A randomized controlled study.

Rationale: Securing the airway timely and safely is of prime importance and thus a laryngoscope which offers this benefit over a Macintosh laryngoscope would be a suitable addition in scenarios requiring emergency endotracheal intubations.

Aim: To study and compare of Airtraq TM video laryngoscope with Macintosh laryngoscope for emergency endotracheal intubation in adult patients

Objectives:

Primary Objective: Comparison of time to successful intubation between Airtraq TM videolaryngoscope and Macintosh laryngoscope.

Secondary objectives: To study and compare the following:

1.     First pass intubation success rates between Airtraq TM and Macintosh laryngoscope.

2.     Cormack- Lehane assessment for the glottis view by both the Airtraq TM videolaryngoscope and Macintosh laryngoscope.

3.     Number of attempts for successful endotracheal intubation with both

Airtraq TM and Macintosh laryngoscope.

4.     Ease of intubation with either device using a three point scoring system of good, satisfactory and poor based on visualization of glottis, need of manipulations to aid intubation, and success at the first attempt at intubation 

5.     Incidence of esophageal intubation, failed intubation (one in which trachea cannot be intubated with the chosen laryngoscope by 2 attempts and the third attempt will be made with a change of device or one which took >120 seconds) and dental trauma.

Place of study: The proposed study will be conducted in Department of Anaesthesiology and Critical Care, University College of Medical Sciences & Guru Teg Bahadur Hospital, Delhi.

Study period: The duration of study will be from April 2024 to August 2025.

Study design: Randomised controlled study.

Sample size:  patients in each group, total 70 patients.

Patient selection:

Inclusion criteria:

A total of 70 (35 in each group) consenting adult patients between the ages of 18-70 years requiring emergency endotracheal intubation in the hospital premises by a team of anaesthesiologists.

Exclusion criteria:

1.     Endotracheal intubations performed in the operating room

2.     Endotracheal intubations performed in the intensive care unit

3.     Patients in whom surgical airway will be required as the first option to secure a definite airway

 

Randomization, group allocation: Computer generated random number table and sealed opaque for allocation concealment

Group A: Intubation using Airtarq TM laryngoscope.

Group M: Intubation using Macintosh direct laryngoscope

Statistical Analysis:

•                Data will be coded and recorded in MS Excel spreadsheet program. SPSS v23 (IBM Corp.) will be used for data analysis.

•                Descriptive statistics will be elaborated in the form of means/standard deviations and medians/IQRs for continuous variables, and frequencies and percentages for categorical variables.

•                Group comparisons for continuously distributed data will be made using independent sample ‘t’ test when comparing two groups. If data will be found to be non-normally distributed, appropriate non-parametric tests in the form of Wilcoxon Test will be used for these comparisons.

•                Statistical significance will be kept at p < 0.05


 

 
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