I-gel Versus Classic-Laryngeal Mask Airway (C-LMA) as a Conduit for Tracheal Intubation Using Ventilating Bougie

NCT02566135 | Completed Results

• 1 other identifier: ECR/85/Inst/GJ/2013
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

Brief Summary

Supraglottic Airway devices(SGAs) like I-Gel and C-LMA ( classic laryngeal mask airway ) have been used as a conduit for tracheal intubation using ventilating bougie. General Anaesthesia with tracheal intubation is one of the technique for giving anaesthesia. Tracheal intubation may become difficult sometimes and endangers patients life. Using SGAs as a conduit for tracheal intubation helps in securing airway. This will be further facilitated by using ventilating bougie, as it maintains oxygenation.

Conditions

Intubation; Difficult

Keywords

C-LMA; I-gel; ventilating bougie; intubation

Outcome Measures

Primary Outcomes (5)

• Number of Attempts for I-gel or Classic-LMA Insertions

  60 seconds

• Number of Attempts for Ventilating Bougie Insertions Through I-gel or C-LMA

  45 seconds

• Number of Attempts for Railroading of Endotracheal Tube Over Ventilating Bougie

  30 seconds

• Time of Insertion

  5 minutes

• Total Intubation Time

  5 minutes

Secondary Outcomes (3)

• Heart Rate

  25 minutes

• Systolic Blood Pressure

  25 minutes

• Diastolic Blood Pressure

  25 minutes

Study Arms (2)

Group-I

ACTIVE COMPARATOR

Tracheal intubation using I-gel and ventilating bougie insertion. In Group-I, following general anaesthesia I-gel is to be inserted, through it ventilating bougie is to be inserted then I-gel is to be removed and endotracheal tube is to be railroaded over ventilating bougie. Then ventilating bougie is to be removed.

Device: Tracheal Intubation using I-gel and ventilating bougie

Group-C

ACTIVE COMPARATOR

Tracheal intubation using C-LMA and ventilating bougie insertion. In Group-C, following general anaesthesia C-LMA is to be inserted, through it ventilating bougie is to be inserted then C-LMA is to be removed and endotracheal tube is to be railroaded over ventilating bougie. Then ventilating bougie is to be removed.

Device: Tracheal Intubation using C-LMA and ventilating bougie

Interventions

Tracheal Intubation using I-gel and ventilating bougie DEVICE

Following general anaesthesia I-gel was inserted. After proper placement . ventilating bougie was inserted. Once it's placement is confirmed I-gel was removed keeping the ventilating bougie in situ. Then appropriate sized endotracheal tube was railroaded over ventilating bougie then it (v.bouggie) was removed . Proper placement of endotracheal tube was confirmed by bilateral equal chest excursion and air entry on auscultation, absence of gastric insuffflation sound over epigastrium and 'sine' wave on capnography. Maximum 3 attempts were allowed for I-gel, ventilating bougie and endotracheal tube.

Group-I

Tracheal Intubation using C-LMA and ventilating bougie DEVICE

Following general anaesthesia C-LMA was inserted. After proper placement of C-LMA, ventilating bougie was inserted. It's placement was confirmed and C-LMA was removed after deflation of cuff keeping the ventilating bougie in situ. Then appropriate sized endotracheal tube was railroaded over ventilating bougie. It's placement was confirmed by bilateral equal air entry and chest excursion, absence of gastric insufflation sound over epigastrium and 'sine' wave on capnography. Maximum 3 attempts were allowed for C-LMA , ventilating bougie and endotracheal tube.

Group-C

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• age 18 to 60 years
• Gender : either sex
• American society of Anaesthesiologist's Physical Status (ASAPS) I and II
• Patients posted for surgery requiring general anaesthesia and endotracheal intubation.

You may not qualify if:

• age \<18 years and \> 60 years
• ASAPS III or IV
• Obesity body mass index \>25
• Patients with mouth opening \<2cms
• Patients with Malampatti grade III and IV
• Patients having history of gastro-esophageal reflux disease
• Patients with history of inadequate fasting
• Patients with known or anticipated difficult tracheal intubation or face-mask ventilation.

Sponsors & Collaborators

• Medical College Baroda: lead

Related Publications (3)

• Kapoor S, Jethava DD, Gupta P, Jethava D, Kumar A. Comparison of supraglottic devices i-gel((R)) and LMA Fastrach((R)) as conduit for endotracheal intubation. Indian J Anaesth. 2014 Jul;58(4):397-402. doi: 10.4103/0019-5049.138969.

  PMID: 25197106 BACKGROUND

• Wong DT, Yang JJ, Mak HY, Jagannathan N. Use of intubation introducers through a supraglottic airway to facilitate tracheal intubation: a brief review. Can J Anaesth. 2012 Jul;59(7):704-15. doi: 10.1007/s12630-012-9714-8. Epub 2012 Jun 1.

  PMID: 22653838 RESULT

• Singh J, Yadav MK, Marahatta SB, Shrestha BL. Randomized crossover comparison of the laryngeal mask airway classic with i-gel laryngeal mask airway in the management of difficult airway in post burn neck contracture patients. Indian J Anaesth. 2012 Jul;56(4):348-52. doi: 10.4103/0019-5049.100815.

  PMID: 23087456 RESULT

Limitations and Caveats

The use of fiber optic bronchoscope for confirmation of proper placement of I-gel and C-LMA would have been better. Also One can see the passage of ventilating bougie through I-gel and C-LMA into larynx and trachea.

Results Point of Contact

• Title: Dr Aditi Amrutlal Dhimar
• Organization: Medical College, Baroda.

dhimaraditi@yahoo.in

09825334605

Study Officials

• Aditi A Dhimar, M.D.(anaes)

  CDSCO

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR ADITI AMRUTLAL DHIMAR

Study Record Dates

• First Submitted: September 7, 2015
• First Posted: October 2, 2015
• Study Start: March 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: February 1, 2015
• Last Updated: July 27, 2018
• Results First Posted: July 27, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share