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

I-gel Versus C-LMA as a Conduit for Tracheal Intubation Using Ventilating Bougie

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.

Study Overview

• Status: Completed
• Conditions: Intubation; Difficult
• Intervention / Treatment: Device: Tracheal Intubation using I-gel and ventilating bougie; Device: Tracheal Intubation using C-LMA and ventilating bougie

Detailed Description

SGAs have been used as a conduit for tracheal intubation using ventilating bougie. Patients were anaesthetised with intravenous induction agent, non-depolarising muscle relaxant and then SGAs were inserted. Two groups were compared. In group I : I-gel was inserted, its position was confirmed and then ventilating bougie was inserted through it. It's position was confirmed, then I-gel was removed , Endotracheal tube was railroaded over ventilating bougie and it's position was confirmed. In group C : C-LMA was inserted, its position was confirmed and then ventilating bougie was inserted through it. It's position was confirmed, then C-LMA was removed , Endotracheal tube was railroaded over ventilating bougie and it's position was confirmed.

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Group-I; 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; 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.
ACTIVE_COMPARATOR: Group-C; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate	Heart rate to observe at the following time intervals.; Base line; After induction; After dexmedetomidine injection; Supraglottic airway insertion; Ventilating bougie insertion; ETT insertion; 3minute after ETT insertion; 5 minute after ETT insertion; 7 minute after ETT insertion; 10 minute after ETT insertion; 15 minute after ETT insertion Study period is upto 15 minutes, thereafter the study ends here.	25 minutes
Systolic Blood Pressure	Systolic blood pressure measured at following time intervals.; Base line; After Dexmedetomidine injection; After induction of anaesthesia; Supraglottic airway insertion; Ventilating bougie insertion; ETT insertion; 3 minute after ETT insertion; 5 minute after ETT insertion; 7 minute after ETT insertion; 10 minute after ETT insertion; 15 minute after ETT insertion. The study period was upto 15 minutes and thereafter the study ends.	25 minutes
Diastolic Blood Pressure	Diastolic blood pressure measured at following time intervals.; Base line; After Dexmedetomidine injection; After Induction; Supraglottic airway insertion; Ventilating bougie insertion; ETT insertion; 3 minute after ETT insertion; 5 minute after ETT insertion; 7 minute after ETT insertion; 10 minutes after ETT insertion; 15 minute after ETT insertion The study period was upto 15 minutes. thereafter study ends.	25 minutes

Collaborators and Investigators

• Sponsor: Medical College Baroda
• Investigators: Principal Investigator: Aditi A Dhimar, M.D.(anaes), CDSCO

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (ACTUAL): January 1, 2015
• Study Completion (ACTUAL): February 1, 2015

Study Registration Dates

• First Submitted: September 7, 2015
• First Submitted That Met QC Criteria: September 30, 2015
• First Posted (ESTIMATE): October 2, 2015

Study Record Updates

• Last Update Posted (ACTUAL): July 27, 2018
• Last Update Submitted That Met QC Criteria: July 26, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: intubation; I-gel; C-LMA; ventilating bougie
• Other Study ID Numbers: ECR/85/Inst/GJ/2013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO