Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A- Fastrach (control group) | Active Comparator | 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" |
|
| Group B- I-gel | Active Comparator | 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. |
|
| Group C- Protector | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tracheal intubation through "Fastrach" - Group A | Procedure | Insertion of the intubating laryngeal mask "Fastrach" and blind tracheal intubation through the device |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gregorios Voyagis, MD, PhD | University of Patras, Department of Anesthesiology and Critical Care | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Patras | Pátrai | Achaia | 26500 | Greece |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 2, 2025 | |
| Unrelease | Sep 10, 2025 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Tracheal intubation through "I-gel" - Group B | Procedure | Insertion of the supraglottic airway device "i-gel" and tracheal intubation through the device guided by a fiberoptic bronchoscope |
|
| Tracheal intubation through "Protector" - Group C | Procedure | Insertion of the laryngeal mask "Protector" and tracheal intubation through the device guided by a fiberoptic bronchoscope |
|
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 |
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 2, 2025 | Sep 10, 2025 |