Three Different Techniques for Tracheal Intubation Via Supraglottic Airway Devices
NCT ID: NCT04346459
Last Updated: 2023-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2020-01-10
2023-03-23
Brief Summary
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Detailed Description
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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.
1. 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.
2. 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.
3. 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Group A- Fastrach (control group)
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"
Tracheal intubation through "Fastrach" - Group A
Insertion of the intubating laryngeal mask "Fastrach" and blind tracheal intubation through the device
Group B- I-gel
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.
Tracheal intubation through "I-gel" - Group B
Insertion of the supraglottic airway device "i-gel" and tracheal intubation through the device guided by a fiberoptic bronchoscope
Group C- Protector
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.
Tracheal intubation through "Protector" - Group C
Insertion of the laryngeal mask "Protector" and tracheal intubation through the device guided by a fiberoptic bronchoscope
Interventions
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Tracheal intubation through "Fastrach" - Group A
Insertion of the intubating laryngeal mask "Fastrach" and blind tracheal intubation through the device
Tracheal intubation through "I-gel" - Group B
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
Insertion of the laryngeal mask "Protector" and tracheal intubation through the device guided by a fiberoptic bronchoscope
Eligibility Criteria
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Inclusion Criteria
* Written informed consent to participate in the trial
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University Hospital of Patras
OTHER
Responsible Party
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Maria Spyraki
Principal Investigator
Principal Investigators
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Gregorios Voyagis, MD, PhD
Role: STUDY_CHAIR
University of Patras, Department of Anesthesiology and Critical Care
Locations
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University Hospital of Patras
Pátrai, Achaia, Greece
Countries
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Other Identifiers
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11/11/2019anesthesia
Identifier Type: -
Identifier Source: org_study_id
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