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

Study Overview
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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.

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.

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

Conditions
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Intubation; Difficult

Intervention / Treatment
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* Device: Tracheal Intubation using I-gel and ventilating bougie
* Device: Tracheal Intubation using C-LMA and ventilating bougie


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group-I<br>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. | Device: Tracheal Intubation using I-gel and ventilating bougie<br>* 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.<br>|
| Active Comparator: Group-C<br>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. | Device: Tracheal Intubation using C-LMA and ventilating bougie<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Total Intubation Time |  | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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C-LMA, I-gel, ventilating bougie, intubation