comparison of two types of laryngoscope blades for intubation under anesthesia in infants

Completed

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2016/12/007609
• Lead Sponsor: Chacha Nehru Bal Chikitsalya

Brief Summary

Airwaymanagement in infants remains a challenge to anesthesiologist due to various morphological features. Videolaryngoscopeare increasingly being used in this patient population.Truview PCD was the earliest videolaryngoscope introduced for pediatricpatients. It has demonstrated superiority regarding airway management overconventional direct laryngoscopy. Novel C-MAC infant blade (Karl Storz GmbH & Co. KG,Tuttlingen, Germany) has a camera providing an 80° angle of view and a lightsource are recessed from the tip of the blade. The electronic unit sits in ahandle attached to the laryngoscope blade and is connected by a wire to aportable TFT video monitor. The system allows for the Macintosh laryngoscopeblade to be used for direct and indirect laryngoscopy.  C-MAC infant blade has not been prospectivelycompared to Truview videolaryngosocpe in the past. Afterinstitutional research committee’s approval this prospective, randomized, studywill be conducted in 60 ASA Grade – I/II infants  ( 0-12months) ofeither sex admitted for elective surgery under general anesthesia who will be divided into two groups of 60 each:

GroupCM [intubated with the aid ofCMAC laryngoscope (size 0, 1)]

GroupTR (intubated by the Truview PCD (size 0, 1)

After a thorough preanesthetic checkup,adequate fasting as per the ASA guidelines, and written informedparents/guardian consent, the infants will be shifted to the operating room androutine monitors will be applied. Inhalational/ intravenous induction will beachieved as deemed appropriate. Neuromuscular blockade will facilitated byatracurium besylate bromide 0.5 mg/kg and trachea intubated after 180 seconds. Patients allocated to Group TR will be intubated withthe aid of the Truview PCD and appropriate size stylet provided with Truview.In Group CM, the CMAC videolaryngosocpe with an appropriate size stylet will beused to intubate. All intubations will be performed by the anesthesiologistwith more than 10 year experience with intubation in pediatric patients and aprevious experience of at least 20 intubations with the Truview PCD and theC-MAC blade. The time to intubation will bemeasured by an independent observer using stop watch. The number of attemptswas defined as withdrawing the tube to the angle of the mouth and reintroducingit. Single intubation attempt will be limited to <20seconds. Any fall inoxygen saturation to < 95% on the pulse oximeter will be noted and the lungswill be ventilated with 100% oxygen. If more than three attempts or if > 60seconds were required after combined attempts to secure an endotracheal tube,it was considered a failed intubation. Primary endpoint in our study will bethe total time required for successful intubation. The easeof intubation will be graded by the intubating anesthetist on a numericalrating scale. Thedata thus collected will be expressed as a number or mean ± standard deviation.Appropriate statistical tests will be applied for analysis.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-23
• Study Completion: 2017-04-28
• Last Update Posted: 2020-05-31

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

ASA Grade – I/II infants (less than 1 year) of either sex admitted for elective surgery requiring general anesthesia and endotracheal intubation.

Exclusion Criteria

Patients with an ASA physical status greater than Grade II, features suggestive of increased intracranial pressure, increased risk for pulmonary aspiration of gastric contents, known coagulopathy and any pathology of the head and neck will be excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the time required for intubation with CMAC videolaryngosocpe and Truview PCD videolaryngoscope for intubation in infants	time to intubation will be recorded once

Secondary Outcome Measures

Name	Time	Method
first attempt and overall success rate, number of attempts for intubation, the glottis views using Cormack Lehane grading system

Trial Locations

Locations (1)

Chacha Nehru Bal Chikitsalya; 🇮🇳 East, DELHI, India

Chacha Nehru Bal Chikitsalya

🇮🇳East, DELHI, India

Dr Anju Gupta

Principal investigator

9643308220

dranjugupta2009@rediffmail.com