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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Intubation; Difficult

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Tracheal Intubation using I-gel and ventilating bougie

Intervention Type 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-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.

Group Type ACTIVE_COMPARATOR

Tracheal Intubation using C-LMA and ventilating bougie

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes