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

Not Applicable

Completed

• Conditions: Intubation; Difficult
• Interventions: Device: Tracheal Intubation using I-gel and ventilating bougie; Device: Tracheal Intubation using C-LMA and ventilating bougie

• Registration Number: NCT02566135
• Lead Sponsor: Medical College Baroda

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.

Study Timeline

• Study Start: 2014-03
• Primary Completion: 2015-01
• Study Completion: 2015-02
• Study First Submitted: 2015-09-07
• Study First Submitted QC: 2015-09-30
• Study First Posted: 2015-10-02
• Results First Submitted: 2015-11-22
• Status Verified: 2018-07
• Results First Submitted QC: 2018-07-26
• Last Update Submitted: 2018-07-26
• Results First Posted: 2018-07-27
• Last Update Posted: 2018-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group-I	Tracheal Intubation using I-gel and ventilating bougie	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-C	Tracheal Intubation using C-LMA and ventilating bougie	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.

Primary Outcome Measures

Name	Time	Method
Total Intubation Time	5 minutes
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

Secondary Outcome Measures

Name	Time	Method
Diastolic Blood Pressure	25 minutes	Diastolic blood pressure measured at following time intervals.; 1. Base line; 2. After Dexmedetomidine injection; 3. After Induction; 4. Supraglottic airway insertion; 5. Ventilating bougie insertion; 6. ETT insertion; 7. 3 minute after ETT insertion; 8. 5 minute after ETT insertion; 9. 7 minute after ETT insertion; 10. 10 minutes after ETT insertion; 11. 15 minute after ETT insertion The study period was upto 15 minutes. thereafter study ends.
Heart Rate	25 minutes	Heart rate to observe at the following time intervals.; 1. Base line; 2. After induction; 3. After dexmedetomidine injection; 4. Supraglottic airway insertion; 5. Ventilating bougie insertion; 6. ETT insertion; 7. 3minute after ETT insertion; 8. 5 minute after ETT insertion; 9. 7 minute after ETT insertion; 10. 10 minute after ETT insertion; 11. 15 minute after ETT insertion Study period is upto 15 minutes, thereafter the study ends here.
Systolic Blood Pressure	25 minutes	Systolic blood pressure measured at following time intervals.; 1. Base line; 2. After Dexmedetomidine injection; 3. After induction of anaesthesia; 4. Supraglottic airway insertion; 5. Ventilating bougie insertion; 6. ETT insertion; 7. 3 minute after ETT insertion; 8. 5 minute after ETT insertion; 9. 7 minute after ETT insertion; 10. 10 minute after ETT insertion; 11. 15 minute after ETT insertion. The study period was upto 15 minutes and thereafter the study ends.