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

M

Medical College Baroda

Status

Completed

Conditions

Intubation; Difficult

Treatments

Device: Tracheal Intubation using C-LMA and ventilating bougie
Device: Tracheal Intubation using I-gel and ventilating bougie

Study type

Interventional

Funder types

Other

Identifiers

NCT02566135
ECR/85/Inst/GJ/2013

Details and patient eligibility

About

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.

Full 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.

Enrollment

58 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

58 participants in 2 patient groups

Group-I
Active Comparator group
Description:
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.
Treatment:
Device: Tracheal Intubation using I-gel and ventilating bougie
Group-C
Active Comparator group
Description:
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.
Treatment:
Device: Tracheal Intubation using C-LMA and ventilating bougie

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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