A randomised study to compare two techniques for ease of insertion of artificial ventilation tube in children undergoing surgeries under general anaesthesia

Completed

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2021/06/034018
• Lead Sponsor: Chacha Nehru Bal Chikitsalaya

Brief Summary

**INTRODUCTION:** Pediatric airway is not a miniature replica of adult airway and presents unique challenges to anaesthesiologist. C-MAC and McCoy laryngoscopes have been well validated for routine and difficult airway in adult patients, but there is limited data available for their efficacy in pediatric airway management. Hence, we propose this study to compare the performance of C-MAC videolaryngoscope with PEDD blade and McCoy laryngoscope in pediatric airway management.

**AIM OF THE STUDY:** To compare the C-MAC D blade videolaryngoscope with McCoy direct laryngoscope for intubation in children.

**OBJECTIVES**

**PRIMARY OBJECTIVES**

1. To compare the ease of intubation (Intubation Difficulty Scale)

**SECONDARY OBJECTIVES**

1. To compare visualisation of glottic inlet (Modified Cormack and Lehane grading)

2.     To compare the duration of laryngoscopy

3.      To compare the duration of intubation

To To compare the duration of process of intubation

4.     To compare hemodynamic responses

**MATERIAL AND METHODS**

•**Study Design:** Prospective, Randomized Study

• **Study Period: March** 2021 to October 2021

•**Place of study:** Department of Anaesthesia, Chacha Nehru Bal Chikitsalya, New Delhi

·       **Inclusion criteria:**

1.     Patients aged between 4 – 12 years

2.     ASA 1 and ASA 2 patients

3.     Patients undergoing elective surgery requiring general anaesthesia and endotracheal intubation

·       **Exclusion criteria**

1.     Patients with anticipated difficult airway

2.     Children having severe cardiac or respiratory disease

3.     Children with metabolic disease

4.     Children having reactive airway disease

5.     Children having mental retardation or developmental delay

**Outcome Measures:**

**Primary Outcomes**

1.     Intubation Difficulty Scale

**Secondary Outcomes**

1.     Modified Cormack and Lehane grading

2.     Time to best glottic view (time from insertion of laryngoscope blade between the teeth till the best possible view of vocal cords)

3.     Time to intubate (time from best glottic view till passage of ETT through vocal cords)

4.     Total duration of intubation (sum of duration of laryngoscopy and duration of intubation)

5.     Hemodynamic measurements (Heart rate, systolic BP, diastolic BP, mean arterial BP and SpO2 will be recorded at baseline and at 1st min, 3rd min, 5th min and 10th min of intubation.)

6. any incidence of airway complication.

**Methodology:** 70 patients of ASA physical status 1 and 2 scheduled for elective surgeries under GA with endotracheal intubation will be randomised and allocated into one of the two groups; each having 35 patients.

**Statistical Tests:**

Statistical analysis will be performed by the SPSS program for Windows, version 17.0(SPSS, Chicago, Illinois). Continuous variables will be presented as mean ± SD, and categorical variables will be presented as absolute numbers and percentage. Data will be checked for normality before statistical analysis. Normally distributed continuous variables will be compared using the unpaired t test, whereas the Mann-Whitney U test will be used for those variables that are not normally distributed. Categorical variables will be analyzed using either the chi square test or Fisher’s exact test. P<0.05 will be considered statistically significant.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-06
• Study Completion: 2021-10-18
• Last Update Posted: 2023-11-10

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

ASA class 1 and 2.

Exclusion Criteria

1.Patients with anticipated difficult airway 2.Children with known metabolic disease 3.Children having reactive airway disease 4.Known case of Mental retardation or developmental delay.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intubation Difficulty Score	0 min

Secondary Outcome Measures

Name	Time	Method
1.Modified Cormack and Lehane grading	0 minute at the time of laryngoscopy
2.Time to best glottic view	0 minute
3.Time to intubate	0 minute just after intubation
4.Total duration of procedure of intubation	0 minute
5.Hemodynamic measurements (Heart rate, systolic BP, diastolic BP, mean arterial BP and SpO2 will be recorded at baseline and at 1st min, 3rd min, 5th min and 10th min of intubation.)	Baseline,1minute, 3rd minute, 5th minute and 10th minute after intubation

Trial Locations

Locations (1)

Department of Anaesthesia, OT complex, 2nd floor; 🇮🇳 East, DELHI, India

Department of Anaesthesia, OT complex, 2nd floor

🇮🇳East, DELHI, India

Divyamedha Agarwal

Principal investigator

9779587651

divyamedha@gmail.com