Three Different Techniques for Tracheal Intubation Via Supraglottic Airway Devices

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

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

Study Overview

• Status: Completed
• Conditions: Tracheal Intubation
• Intervention / Treatment: Procedure: Tracheal intubation through "Fastrach" - Group A; Procedure: Tracheal intubation through "I-gel" - Group B; Procedure: Tracheal intubation through "Protector" - Group C

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Achaia
    • Patras, Achaia, Greece, 26500
      • University Hospital of Patras

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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"	Procedure: Tracheal intubation through "Fastrach" - Group A; Insertion of the intubating laryngeal mask "Fastrach" and blind tracheal intubation through the device
Active Comparator: 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.	Procedure: 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
Active Comparator: 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.	Procedure: Tracheal intubation through "Protector" - Group C; Insertion of the laryngeal mask "Protector" and tracheal intubation through the device guided by a fiberoptic bronchoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University Hospital of Patras
• Investigators: Study Chair: Gregorios Voyagis, MD, PhD, University of Patras, Department of Anesthesiology and Critical Care

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2020
• Primary Completion (Actual): March 23, 2023
• Study Completion (Actual): March 23, 2023

Study Registration Dates

• First Submitted: April 10, 2020
• First Submitted That Met QC Criteria: April 14, 2020
• First Posted (Actual): April 15, 2020

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 30, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: tracheal intubation; supraglottic airway device
• Other Study ID Numbers: 11/11/2019anesthesia

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No