Comparison of Endotracheal intubation between video laryngoscopy(McGrath) and direct laryngoscopy in children.

Not yet recruiting

• Conditions: Intussusception,

• Registration Number: CTRI/2019/10/021568
• Lead Sponsor: SSG HospitalVadodara

Brief Summary

The study will be a typeof prospective randomised controlled trial undertaken in paediatric patientsadmitted in SSG hospital requiring general anesthesia with endotrachealintubation with a sample size of 88 patients.

Patient will be kept nilby mouth for minimum 6-8 hours before surgery and an intravenous line will besecured. After thorough pre-anaesthetic check up, an informed written consentwill be taken from the patient’s parent / guardian. Cylinders, trolley, airwayequipment and drugs will be kept ready before induction; multipara monitor willbe attached and baseline vital parameters will be noted.

For McGrath videolaryngoscope, paediatric non-channeled blade (size no. 2) will be mounted onthe handle containing battery. The performance of the device will be checked bywatching the clarity of the image on monitor.

For McIntoshlaryngoscope, appropriate sized paediatric blade (size no. 2) will be mountedon the handle. The performance of the device will be checked by adequateintensity of the light.

Appropriate size of ETtube with stylet will be kept ready.

As premedication, Inj.Glycoprrolate 5mcg/kg iv and Inj. Tramadol 2mg/kg iv 5 minutes prior toinduction.

Inductionwill be done with increasing concentrations of sevoflurane starting from 1%with 100% O2 with 6 litres/min flow using Jackson-Rees circuit. The sevofluraneconcentration will be increased by 1% every 2 to 3 breaths. After achievingloss of eyelash reflex, IV Inj Atracurium 0.3-0.5 mg/kg will begiven. Ventilation will be controlled by positive pressure maskventilation after achieving apnoea by the patients on their own and will bemade as uniform as possible with the help of capnography (35-45 cm H2O). Allthe intubation procedures will be done by me. Intubation will be done asfollows -

**Method of Endotracheal intubation:**

â‘      **Group G (with McGrath Video laryngoscopy)**

•       Patient’s head will be kept in neutral position.

•       The McGrath blade of pediatric size (size 2)will be mounted on the McGrath video laryngoscope and introduced from thecenter of the mouth towards the glottis by viewing on the screen of the monitorso that it will barely lift the epiglottis with the tip of the blade.

•       After obtaining optimal laryngeal view, theappropriate size uncuffed, PVC endotracheal tube with stylet will be advancedby the side of the scope viewing on the screen of the monitor.

 â‘        **GroupM (with Macintosh)**

•       Patient’s head will be kept in sniffingposition.

•       Macintosh laryngoscope of appropriate size willbe advanced from right side of the mouth.

•       Vallecula will be lifted and through the glotticopening, tube will be advanced in the trachea.

Time to Glottic exposure (TTG), Cormack andLehane grading of laryngeal view, Time to Intubation (TTI), optimizationmaneuvers like external laryngeal pressure or increasing scope lifting forceand intubation difficulty scale will be recorded.

In case of first trial failure, a second trialwill be performed after mask ventilation. Maximum 2 attempts with the selectedlaryngoscope will be allowed. In case of second trial failure, an alternativedevice (i.e. Macintosh laryngoscope in case of failure with McGrath videolaryngoscope and vice versa) will be used for intubation after mask ventilation.

Failed intubation will be defined as an attemptin which patient could not be intubated even with optimization maneuvers or> 120 secs required to perform the procedures.

**Maintenance :**

Afterintubation, Jackson-Rees circuit will be attached to the endotracheal tube andbilateral air entry will be confirmed by chest auscultation as well as bycapnography and anaesthesia will be maintained withOâ‚‚+Nâ‚‚O (50:50%) with sevoflurane and intermittent Inj Atracurium 0.02mg/kg.

**Reversal:**

At the end of surgery, N2O and anesthetic agent will bestopped before 10 mins and patient will be ventilated with 100% oxygen.Reversal will be done once patient starts spontaneous breathing withIV  Inj. Neostigmine 50 mcg/kg and Inj. Glycopyrrolate 10 mcg/kg.

During this period patient will be ventilated with 100% oxygenwith fresh gas flow of 4- 6 liters/min. Patient will be extubated when regularspontaneous breathing pattern become established and patient is able to openthe eyes on command. Patient will then be shifted to post anaesthesia care unit(PACU).

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2019-03-10
• Study Start: 2019-10-10

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Not specified
• Target Recruitment: 88

Inclusion Criteria

• 1.Patients posted for elective surgery under general anaesthesia requiring endotracheal intubation.
• 2.Age: 01 to 05yrs 3.Weight: 10-20kg 4.Gender: Either gender.
• 5.ASA I & II 6.Mouth opening >20 mm.

Exclusion Criteria

1.Patients with expected difficult airway intubation 2.Patients with congenital anomaly 3.Upper respiratory tract infection 4.Preexisting laryngeal or tracheal pathology 5.Patient’s parents/guardian not willing for participation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total Interval Time for intubation (in seconds)	Total Interval Time for intubation (in seconds)

Secondary Outcome Measures

Name	Time	Method
Glottic Exposure time	Number of attempts of devise insertion

Trial Locations

Locations (1)

SSG Hospital; 🇮🇳 Vadodara, GUJARAT, India

SSG Hospital

🇮🇳Vadodara, GUJARAT, India

DrStuti Bhamri

Principal investigator

8095710767

stutibhamri@gmail.com