Comparison of LMA-Fastrach and I-gel for Blind Tracheal Intubation.

Study Overview
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Brief Summary
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The investigators aim to compare two different types of supraglottic devices for tracheal intubation in patients undergoing elective surgery under general anesthesia. Our hypothesis is that the use of the I-gel supraglottic airway will result in a higher first attempt success rate of blind tracheal intubation.

Detailed Description
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Supraglottic airway devices such as LMA-Fastrach and I-gel provide patent airways during general anesthesia. The LMA-Fastrach is designed to provide a conduit for blind or fiberoptically guided tracheal intubations. However, the success rate of tracheal intubation on the first attempt through this device varies between 50 and 87%. The I-gel is a newer device for airway management which, with its wide bore, allows direct passage of a tracheal tube. Recent studies suggest that the I-gel is easy to insert and that limited experience is needed before a high success insertion rate is obtained. In this prospective and randomized study, we will evaluate the performance of both devices for tracheal intubation in patients undergoing elective surgery under general anesthesia.

Official Title
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Comparison of LMA-Fastrach and I-gel for Blind Tracheal Intubation.

Conditions
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General Anesthesia

Intervention / Treatment
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* Procedure: Tracheal intubation
* Procedure: Tracheal intubation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 and older ASA physical status 1-3 Patients undergoing elective surgery under general anesthesia, requiring endotracheal intubation Exclusion Criteria: ASA physical status 4-5 Contraindications to muscle relaxation Anticipated or known difficult intubation or ventilation Patients with limited mouth opening (less than 2 cm) Patients at increased risk of aspiration, or having an history of symptomatic gastroesophageal reflux or hiatal hernia.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: LMA-Fastrach<br>Induction of general anesthesia with 1,5-2,5 mg/kg propofol and 1-3 mcg/kg fentanyl and neuromuscular relaxation with 0,6 mg/kg of rocuronium. Direct laryngoscopy, evaluation of laryngeal view grade according to Cormack-Lehane classification Insertion of LMA-Fastrach (sizes 3,4 or 5), establishment of ventilation Evaluation of glottic view through LMA-Fastrach using fibrescope (one out of ten patients) Tracheal intubation through the LMA-Fastrach With the endotracheal tube in place, the anaesthesiologist will proceed to the removal of supraglottic device | Procedure: Tracheal intubation<br>* Tracheal intubation through a supraglottic airway device(LMA-Fastrach).<br>|
| Active Comparator: I-gel<br>Induction of general anesthesia with 1,5-2,5 mg/kg propofol and 1-3 mcg/kg fentanyl and neuromuscular relaxation with 0,6 mg/kg of rocuronium. Direct laryngoscopy, evaluation of laryngeal view grade according to Cormack-Lehane classification Insertion of I-gel (sizes 3,4 or 5), establishment of ventilation Evaluation of glottic view through I-gel using fibrescope (one out of ten patients) Tracheal intubation through the I-gel With the endotracheal tube in place, the anaesthesiologist will proceed to the removal of supraglottic device | Procedure: Tracheal intubation<br>* Tracheal intubation through a supraglottic airway device(I-gel).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First attempt success rate of tracheal intubation. |  | After successful insertion of tracheal tube | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time needed for successful insertion of a supraglottic device. |  | After insertion | 
| First and total attempt success rate of supraglottic device insertion. |  | After insertion | 
| Total time and number of attempts needed to obtain successful tracheal intubation. |  | After tracheal intubation | 
| Fiberoptic view following the supraglottic device insertion. |  | After insertion of the device | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tracheal intubation, supraglottic airway devices