University Hospital of Patras
Pátrai, Achaia, 26500, Greece
NCT Number: NCT04346459
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
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All sexes
Interventional
Not applicable
Pátrai, Achaia, 26500, Greece
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Insertion of the intubating laryngeal mask "Fastrach" and blind tracheal intubation through the device
Insertion of the supraglottic airway device "i-gel" and tracheal intubation through the device guided by a fiberoptic bronchoscope
Insertion of the laryngeal mask "Protector" and tracheal intubation through the device guided by a fiberoptic bronchoscope
Time frame: Up to study completion, an average of 2 years
Recording of successful tracheal intubation at first attempt (yes/no) and evaluation of the success rate at first attempt
Time frame: Up to study completion, an average of 2 years
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)
Time frame: Up to study completion, an average of 2 years
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)
University Hospital of Patras
Other
Evaluation of Three Different Techniques for Tracheal Intubation Via Supraglottic Airway Devices: A Comparative Randomised Study
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