Clinical trial NCT02566135: I-gel Versus Classic-Laryngeal Mask Airway (C-LMA) as a Conduit for Tracheal Intubation Using Ventilating Bougie
Official title: I-gel Versus C-LMA as a Conduit for Tracheal Intubation Using Ventilating Bougie
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation; Difficult
Keywords: C-LMA
I-gel
ventilating bougie
intubation
Lead sponsor: Medical College Baroda
Sponsor class: OTHER
First posted: 2015-10-02
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Attempts for I-gel or Classic-LMA Insertions
timeFrame: 60 seconds
measure: Number of Attempts for Ventilating Bougie Insertions Through I-gel or C-LMA
timeFrame: 45 seconds
measure: Number of Attempts for Railroading of Endotracheal Tube Over Ventilating Bougie
timeFrame: 30 seconds
measure: Time of Insertion
timeFrame: 5 minutes
measure: Total Intubation Time
timeFrame: 5 minutes
Secondary outcomes:
measure: Heart Rate
timeFrame: 25 minutes
measure: Systolic Blood Pressure
timeFrame: 25 minutes
measure: Diastolic Blood Pressure
timeFrame: 25 minutes
Other outcomes:
Locations:
Study officials:
affiliation: CDSCO
name: Aditi A Dhimar, M.D.(anaes)
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.