Comparison of two videolaryngoscopes for intubation

Completed

• Conditions: Cholesteatoma of mastoid, (2) ICD-10 Condition: H652||Chronic serous otitis media, (3) ICD-10 Condition: K36||Other appendicitis,

• Registration Number: CTRI/2019/11/022061
• Lead Sponsor: University College of Medical Sciences

Brief Summary

**Rationale:**Laryngoscopyand intubation are very crucial for securing airway in patients.Videolaryngoscopy has made intubation much safer and easier than conventionallaryngoscopy. Thechannelled videolaryngoscopeshave the potential to reduce theduration of laryngoscopy and intubation and thus the consequent hemodynamic responses.AirtraqTMand King VisionTMchannelled videolaryngoscopeshave been compared in a limited number of studies and these studies havecontradictory results.

**Aim–**To compare Airtraqand King Vision Videolaryngoscopes for tracheal intubation**.**

**Objectives: -** To compare Airtraqand King Vision channelled Videolaryngoscopes in terms of-

**PRIMARY OBJECTIVE**-Time to successful endotracheal intubation

**SECONDARY OBJECTIVES-**

**1.** **Intubatingconditions-**

·        Time to view the vocal cords

·        Time to advance the tube

·        Intubation difficulty score

·        Number and type of manoeuvres used duringintubation

·        First attempt success rate

·        Number of attempts

·        Overall success rate

·        Incidence of failed intubation

**2.** **Laryngoscopic view**-

·        Cormack- Lehane grading

·        Percentage of glottic opening(POGO) score

**3.** **Hemodynamicresponses-**

·        Changes in Systolic, Diastolic and Mean Arterialblood pressure

·        Changes in heart rate

·        Changes in SpO2

**4.** **Complicationsif any-**Blood staining of the device / Hoarseness/Sore throat/anyother

**Placeof study** Department of Anaesthesiology, Critical Care & PainMedicineUniversity College of Medical Sciences (University of Delhi) and GuruTeg Bahadur Hospital, Delhi

**Studyperiod:** November 2019 to April 2021.

**Studydesign:** After obtaining approval from the Institutional EthicsCommittee, this prospective, randomized analytical study will be undertakenafter taking written informed consent from all the participants.

**Samplesize: –** 25patients for each group is required. Therefore, a total number of 50 patientswill be included in the study.

**PATIENTSELECTION:**

**Inclusion criteria**

1.    Age-20-60 years

2.    Weight– 40-70 kg

3.    ASAGrade I and II

4.    Mallampattigrade I and II

5.    Patientscheduled for elective surgery requiring endotracheal intubation

 **Exclusion criteria**

1.    Patientswith risk of aspiration

2.    Difficultintubation

3.    Patientswith mouth opening less than 18mm in males and 16mm in females

4.    Patientsnot giving consent to participate in the study

5.    Patientswith cardiovascular diseases

6.    Patientswith oral pathology

7.    Patientswith neck flexion deformity

**Randomizationand group allocation: -**Usinga computer generated random number table, the patients will be randomlyallocated to one of the two groups**-**

Group A - patients undergoing intubation byAirtraq

Group K - patients undergoing intubation byKing Vision.

**MATERIALS AND METHODS**

Patient fulfillingthe above mentioned inclusion criteria and willing to become a part of thestudy will be selected.A pre-anaesthetic evaluation will be done one day priorto surgery. A written informed consent will be taken. Tablet Alprazolam 0.25mgand Ranitidine 150mg shall be administered on the night before and morning ofsurgery. In the operating room, monitors will be attached and patient’s vitalswill be recorded. (ECG, NIBP, heart rate).Intravenous line will be secured.Standardgeneral anaesthesia technique will be started. After confirmation of adequatebag and mask ventilation, neuromuscular relaxation will be instituted usingInj. Vecuronium 0.1mg/kg i.v. Videolaryngoscopy will be performed after atleast 3 min of muscle relaxation with the laryngoscope as per group allocation.After obtaining glottic view C-L grading and POGO scoring will be done.In caseswith any difficulty in obtaining the glottic view manoeuvres will beapplied.Intubation will then be performed with an appropriately sizedendotracheal tube.

The followingparameters will be noted-

1.Time to view thevocal cords

2. Time to advancethe tube

3.  Intubation Difficulty Score

4.  Any manoeuvre used

5.  Heart rate

6.  Systolic blood pressure

7.  Diastolic blood pressure

8.  Meanarterial blood pressure

Parameters will berecorded at following intervals-.Baseline, T1, T2, T3, T4, T5, T6, T7, T8. Thereafterthe readings will be taken 1, 3, 5, 10, 15 minutes after intubation.

**Outcomemeasures**

1.    Timeto successful endotracheal intubation

2.    Timeto view the vocal cords

3.    Timeto advance the tube

4.    IntubationDifficulty Score

5.    Firstattempt success rate

6.    Numberof attempts of laryngoscopy and intubation

7.    Anymanoeuvres required

8.    Overallsuccess rate

**9.** Incidenceof failed intubation

10. Laryngoscopicview: POGO Score,Cormack & Lehane Grading

11. Hemodynamicresponses

12. Complications

**Statisticalanalysis**

Allstatistical analysis will be carried out in SPSS version 20.0. One timemeasured quantitative measures will be compared by Unpaired t-test/ MannWhitney U test depending on the nature of data. Repeatedly measuredquantitative measures will be compared by repeated measure ANOVA followed byDunnett’s test. Qualitative parameter will be compared by Chi Square/ Fischerexact test. P value <0.05 will be considered significant.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-25
• Last Update Posted: 2022-09-14

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Weight – 40-70 kg ASA Grade I and II Mallampatti grade I and II Patient scheduled for elective surgeries requiring endotracheal intubation.

Exclusion Criteria

Patients with risk of aspiration Difficult intubation Patients with mouth opening less than 18 mm in males and 16 mm in females Patients not giving consent to participate in the study Patients with cardiovascular diseases Patients with oral pathology Patients with neck flexion deformity.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to successful endotracheal intubation	Once after intubation

Secondary Outcome Measures

Name	Time	Method
Haemodynamic parameters	Baseline: just before induction.
Intubation characteristics	Laryngoscopic view

Trial Locations

Locations (1)

UCMS and GTB Hospital; 🇮🇳 East, DELHI, India

UCMS and GTB Hospital

🇮🇳East, DELHI, India

Dr Sujata Chaudhary

Principal investigator

9625900800

sujatac462@gmail.com