Clinical trial NCT04346459: Three Different Techniques for Tracheal Intubation Via Supraglottic Airway Devices
Official title: Evaluation of Three Different Techniques for Tracheal Intubation Via Supraglottic Airway Devices: A Comparative Randomised Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tracheal Intubation
Keywords: tracheal intubation
supraglottic airway device
Lead sponsor: University Hospital of Patras
Sponsor class: OTHER
First posted: 2020-04-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Success rate of intubation at first attempt
timeFrame: Up to study completion, an average of 2 years
Secondary outcomes:
measure: Time required for tracheal intubation
timeFrame: Up to study completion, an average of 2 years
measure: Time required for successful supraglottic airway device/ laryngeal mask placement
timeFrame: Up to study completion, an average of 2 years
Other outcomes:
Locations:
city: Patras
country: Greece
facility: University Hospital of Patras
state: Achaia
Study officials:
affiliation: University of Patras, Department of Anesthesiology and Critical Care
name: Gregorios Voyagis, MD, PhD
role: STUDY_CHAIR
References: