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Clinical Trials/NCT04346459
NCT04346459
Completed
Not Applicable

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

University Hospital of Patras1 site in 1 country120 target enrollmentJanuary 10, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tracheal Intubation
Sponsor
University Hospital of Patras
Enrollment
120
Locations
1
Primary Endpoint
Success rate of intubation at first attempt
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 10, 2020
End Date
March 23, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital of Patras
Responsible Party
Principal Investigator
Principal Investigator

Maria Spyraki

Principal Investigator

University Hospital of Patras

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

Outcomes

Primary Outcomes

Success rate of intubation at first attempt

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

Secondary Outcomes

  • Time required for tracheal intubation(Up to study completion, an average of 2 years)
  • Time required for successful supraglottic airway device/ laryngeal mask placement(Up to study completion, an average of 2 years)

Study Sites (1)

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