Three Different Techniques for Tracheal Intubation Via Supraglottic Airway Devices

NCT04346459 | Completed

• 1 other identifier: 11/11/2019anesthesia
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Tracheal Intubation

Keywords

tracheal intubation; supraglottic airway device

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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 Arms (3)

Group A- Fastrach (control group)

ACTIVE COMPARATOR

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

Group B- I-gel

ACTIVE COMPARATOR

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

Group C- Protector

ACTIVE COMPARATOR

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

Interventions

Tracheal intubation through "Fastrach" - Group A PROCEDURE

Insertion of the intubating laryngeal mask "Fastrach" and blind tracheal intubation through the device

Group A- Fastrach (control group)

Tracheal intubation through "I-gel" - Group B PROCEDURE

Insertion of the supraglottic airway device "i-gel" and tracheal intubation through the device guided by a fiberoptic bronchoscope

Group B- I-gel

Tracheal intubation through "Protector" - Group C PROCEDURE

Insertion of the laryngeal mask "Protector" and tracheal intubation through the device guided by a fiberoptic bronchoscope

Group C- Protector

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients (age ≥ 18 yrs) scheduled for an elective surgery under general anesthesia
• Written informed consent to participate in the trial

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital of Patras: lead

Study Sites (1)

University Hospital of Patras

Pátrai, Achaia, 26500, Greece

Location

Study Officials

• Gregorios Voyagis, MD, PhD

  University of Patras, Department of Anesthesiology and Critical Care

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 10, 2020
• First Posted: April 15, 2020
• Study Start: January 10, 2020
• Primary Completion: March 23, 2023
• Study Completion: March 23, 2023
• Last Updated: July 3, 2023

Record last verified: 2023-06

Locations

GR (1)