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

Intubation; Difficult Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02566135
• Other study ID #: ECR/85/Inst/GJ/2013
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: February 2015

Study information

• Verified date: July 2018
• Source: Medical College Baroda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: February 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intubation; Difficult

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical College Baroda

References & Publications (3)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Attempts for I-gel or Classic-LMA Insertions		60 seconds
Primary	Number of Attempts for Ventilating Bougie Insertions Through I-gel or C-LMA		45 seconds
Primary	Number of Attempts for Railroading of Endotracheal Tube Over Ventilating Bougie		30 seconds
Primary	Time of Insertion		5 minutes
Primary	Total Intubation Time		5 minutes
Secondary	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
Secondary	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
Secondary	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