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Comparison of C-MAC and Mc-GRATH laryngoscopes for intubation in COVID scenario.

Not yet recruiting
Conditions
Nill ( Manikin based study, participants - Doctors)
Registration Number
CTRI/2020/06/025927
Lead Sponsor
All India Institute of Medical Sciences
Brief Summary

Aims and Objectives

Aim – to compare CMAC and McGrath MAC video laryngoscopes with same size and shaped blades for use with PPE and aerosol box among medical professionals.

Primary objective - Time to intubation with each device. (Defined as the time starting from passing the tip of the laryngoscope blade into the mouth of the manikin till observation of first chest expansion with the resuscitation bag)

Secondary outcomes –

1) Number of attempts taken for successful intubation. (Failed attempt – defined as oesophageal intubation or time of more than 120 seconds, Failed intubation defined as – inability to successfully place the tube in 3 attempts)

2) Cormack-Lehane (CL) grade.

3) POGO (Percentage of glottic opening) score.

4) Optimization manoeuvres – Re-adjustment of head position, OELM by second assistant.

5) Dental trauma. (audible clicks from the manikin’s mouth noted – each audible click signifying tooth breakage)

6) Difficult of using the device. (graded on scale of 0 to 10; 0 -extremely difficult, 10 extremely easy)

7) User’s preference between the two laryngoscopes – based on the following parameters a) ease of insertion of laryngoscope blade b) ease of visualization of vocal cords c) ease of passing the endotracheal tube d) overall preference.

Study design – randomised crossover trial.

Inclusion criteria – medical professionals (non anaesthetists) with no previous experience of intubation with video laryngoscopes.

Exclusion criteria – previous experience of intubating in similar setting (i.e. within intubation box with video laryngoscope)

Study duration – one week.

Sample size - 30 medical professionals in each group.

Equipment –

• Laerdal Airway Management Trainer (Laerdal Medical Korea, Ltd, Seoul, Korea) with the normal airway setting.

• Video laryngoscope – C-MAC with size 4 blade, Mc GRATH MAC with blade size 4.

• 7.5 cuffed endotracheal tube (CETT) with a malleable plastic stylet (PortexTM intubation stylet, Smiths Medical ASD, Inc., Norwell, MA, USA). Tube with stylet will be bent in a J-shape for intubation with both the devices.

• Manual resuscitation device (AMBU bag).

• Long connector (catheter mount)

• Intubation box. (cuboidal box made of transparent fibreglass with the following dimensions – base and top 70\*40 cm, front face 70\*50 cm, lateral walls 50\*40 cm back side open and covered with a transparent polythene. Working channels in the front face – two circular channels 10 cm in diameter cut out in the centre of front face.

• PPE face protection components – visor, eye shield, N 95 masks.

Experimental design –

All the participants will be explained about the procedure of intubation by an experienced anaesthetist regarding technique of intubation with both devices, assessment of Cormack Lehane (CL) grading and percentage of glottic opening (POGO score). This will be followed by video demonstration of the intubation technique using the two devices and practise with both devices for 5 times with each device on a Laerdal\_ Airway Management Trainer (Laerdal, Stavanger, Norway) without intubation box and PPE face protection components to familiarize with the intubation technique. After this they will practice with in a COVID simulated scenario (5 times with each device) after wearing N95 masks, eye shield and visor to protect the face with the manikin kept inside intubation box. The intubating personal will have to insert their arms inside the working channels of the intubation box to access the manikin and the intubating equipment’s, thus standing away from the airway of the manikin and intubating standing outside the intubation box. The screen of the C-MAC VL would be outside the intubation box in front of the intubating personal and the Mc GRATH-MAC will

be inside the intubation box. An assistant will be on the opposite side towards the shoulder side of manikin to remove the stylet once the endotracheal tube passes the vocal cords and inflate the cuff of the tube before the intubating person connects the tube to the catheter mount and takes one end of catheter mount outside the box through the working channel to be connected to the AMBU bag.

The participants will not be allowed to watch others during insertion attempts, to avoid any learning effect throughout the whole process. After the initial practise sessions, the participants will be randomly assigned to start with one of the two devices 24 hours after the training session. At the start of this final session participants will be randomly allotted to use one of the two video laryngoscopes as the initial device for intubation.

An independent observer will time the intubation attempts using stopwatch and record glottic view using POGO score (Percentage of glottic view seen) and modified Cormack-Lehane Grade, time to intubate (time taken from insertion of the blade between the teeth until ability to ventilate with AMBU bag), first attempt success rate, failed intubation (oesophageal intubation), or failed attempt – (where intubation of the trachea required > 120 s to perform), the number of optimization maneuvers to aid tracheal intubation and dental trauma as assessed by the number of audible teeth clicks will be noted.

Sample size estimation.

Based on results of a similar study(12) for continuous outcome of intubation time for overall attempts between McGrath-MAC (21.8 ±1.2) versus C-MAC (23.2 ± 1.2) group with equal size (r=1) among both groups assuming alpha (0.05) and power of the study (80%). The total sample size calculated is 24 with minimum sample size required in each group as 12. For the present study 30 medical professionals will be enrolled in each group.

Statistical analysis:

Statistical analysis will be performed using SPSS Version 24 (SPSS Inc, Chicago IL, USA). The normal distribution of data will be tested using the Shapiro-Wilk test. Comparison of success rates will be analysed using Chi-squared tests. Analyses of continuous data were performed using student’s T test (unpaired) (for parametric data) and independent-samples Mann Whitney U test (for non-parametric data) with Bonferroni correction. A p-value of < 0.05 will be considered significant.

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
All
Target Recruitment
30
Inclusion Criteria

medical professionals (non anaesthetists) with no previous experience of intubation with video laryngoscopes.

Exclusion Criteria

previous experience of intubating in similar setting (i.e. within intubation box with video laryngoscope).

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Time to intubation with each device. (Defined as the time starting from passing the tip of the laryngoscope blade into the mouth of the manikin till observation of first chest expansion with the resuscitation bag)Outcome noted at - Baseline.(i.e. at the time of intubation).
Secondary Outcome Measures
NameTimeMethod
1) Number of attempts taken for successful intubation.2) Cormack-Lehane (CL) grade.

Trial Locations

Locations (1)

National Cancer Institute

🇮🇳

Jhajjar, HARYANA, India

National Cancer Institute
🇮🇳Jhajjar, HARYANA, India
Saurabh Vig
Principal investigator
9538247725
saurabh377@yahoo.com

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