Three Different Techniques for Tracheal Intubation Via Supraglottic Airway Devices

Study Overview
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Brief Summary
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This study compares three different supraglottic airway devices used as a conduit for tracheal intubation in order το determine which one achieves the highest success rate of first attempt intubation

Detailed Description
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Prospective, randomized, comparative, clinical, controlled study, that is approved by the Ethics Commitee of the University of Patras (10.12.2019) and takes part in the University Hospital of Patras. Depending on the supraglottic airway device (SGA)/ laryngeal mask airway (LMA) used to achieve intubation (Fastrach, I-gel, Protector), partcipants will be randomly allocated into three groups; Group A, B and C (Fastrach, I-gel, Protector respectively). In the preoperative setting, a complete preanesthetic evaluation will be performed, including a detailed airway assessment (prediction of difficulty in face mask ventilation, insertion of SGA/LMA and intubation). All patients are scheduled to undergo an elective surgery under general anesthesia. Before induction, all patients will be preoxygenated with FiO2 100% for at least 5 minutes. After induction, using rocuronium 0.6mg/kg to facilitate neuromuscular blockade, face mask ventilation follows. Group A- Fastrach: The intubating laryngeal mask airway (Fastrach) will be placed to the patients of this group. After the mask is correctly placed and patients are adequately ventilated, they will be intubated through the mask using its own endotracheal tube according to the blind technique insertion. Group B- I-gel: The supraglottic airway device (I-gel) will be placed to the patients of this group. After the mask is correctly placed and patients are adequately ventilated, they will be intubated through the mask using a fiberoptic bronchoscope to guide endotracheal tube's placement. Group C- Protector: The supraglottic airway device (Protector) will be placed to the patients of this group. After the mask is correctly placed and patients are adequately ventilated, they will be intubated through the mask using a fiberoptic bronchoscope to guide endotracheal tube's placement. In all groups (A, B, C) up to 3 attempts of SGA/LMA placement and up to 3 attempts of intubation are allowed to be made. In case of an emerging unpredicted difficult airway and a concurrent unsuccessful SGA/LMA placement, then the algorithm of the difficult airway will be immediately followed. Video-assisted laryngoscopy will be the first option rescue alternative. The time of the whole procedure from the beginning of SGA's/LMA's placement effort until the successful intubation will be recorded, along with the evaluation of the success rate of first intubation attempt.

Official Title
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Evaluation of Three Different Techniques for Tracheal Intubation Via Supraglottic Airway Devices: A Comparative Randomised Study

Conditions
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Tracheal Intubation

Intervention / Treatment
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* Procedure: Tracheal intubation through Fastrach - Group A
* Procedure: Tracheal intubation through I-gel - Group B
* Procedure: Tracheal intubation through Protector - Group C


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients (age ≥ 18 yrs) scheduled for an elective surgery under general anesthesia Written informed consent to participate in the trial Exclusion Criteria: Age < 18 yrs Non- elective (urgent/ emergency) procedures or multi-trauma patients Obstetric population Surgery performed under regional anesthesia Contraindication to LMA insertion Predicted difficulty in LMA insertion (at least one out of four RODS criteria) Contraindication to the use of neuromuscular blockade or situations that require spontaneous breathing Indication for awake intubation or surgical airway Patients' involvement in another clinical trial

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A- Fastrach (control group)<br>Group of 40 patients scheduled for elective surgery under general anesthesia are planned to be intubated using intubating laryngeal mask airway Fastrach following blind intubating method through Fastrach | Procedure: Tracheal intubation through Fastrach - Group A<br>* Insertion of the intubating laryngeal mask Fastrach and blind tracheal intubation through the device<br>|
| Active Comparator: Group B- I-gel<br>Group of 40 patients scheduled for elective surgery under general anesthesia are planned to be intubated using I-gel supraglottic airway device as a conduit for tracheal intubation guided by a fiberoptic bronchoscope. | Procedure: Tracheal intubation through I-gel - Group B<br>* Insertion of the supraglottic airway device i-gel and tracheal intubation through the device guided by a fiberoptic bronchoscope<br>|
| Active Comparator: Group C- Protector<br>Group of 40 patients scheduled for elective surgery under general anesthesia are planned to be intubated using the Protector laryngeal mask airway as a conduit for tracheal intubation guided by a fiberoptic bronchoscope. | Procedure: Tracheal intubation through Protector - Group C<br>* Insertion of the laryngeal mask Protector and tracheal intubation through the device guided by a fiberoptic bronchoscope<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate of intubation at first attempt | Recording of successful tracheal intubation at first attempt (yes/no) and evaluation of the success rate at first attempt | Up to study completion, an average of 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time required for tracheal intubation | Time required from the beginning of the insertion of the supraglottic airway device/ laryngeal mask until the endotracheal tube is successfully placed confirmed by continuous waveform capnography (3 cycles) | Up to study completion, an average of 2 years | 
| Time required for successful supraglottic airway device/ laryngeal mask placement | Time required from the beginning of the insertion of the supraglottic airway device/ laryngeal mask until adequate ventilation is confirmed by continuous waveform capnography (3 cycles) | Up to study completion, an average of 2 years | 

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