Orotracheal Intubation Using Flexible Fibro Bronchoscope With vs Without Supraglottic Device

NCT04356547 | Completed

• 1 other identifier: F-017-00
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 2

Brief Summary

Randomized clinical trial conducted in pediatric simulators that wishes to compare the success of fiberoptic tracheal intubation using supraglottic device AuraGain compared with fiberoptic tracheal intubation without laryngeal mask, performed by anesthesiologists and anesthesiology residents.

Conditions

Intubation;Difficult

Keywords

Fiberoptic intubation; Pediatrics; laryngeal mask; Intubation, intratracheal; Manikins

Outcome Measures

Primary Outcomes (1)

• Successful intubation at the first attempt using fiber optic through laryngeal mask AuraGain compared to fiberoptic intubation without laryngeal mask

  Incidence of successful tracheal intubation at the first attempt using fiberoptic through laryngeal mask AuraGain and without laryngeal mask. After this procedure, tracheal intubation with positive pressure ventilation in the pediatric simulators will be verified.

  immediately after intubation

Secondary Outcomes (6)

• Time required to achieve tracheal intubation using fiber optic through laryngeal mask AuraGain compared to fiberoptic intubation without laryngeal mask

  immediately after intubation

• Successful intubation at the second and third attempts using fiber optic through laryngeal mask AuraGain compared to fiberoptic intubation without laryngeal mask

  immediately after intubation

• Global success of orotracheal intubation using fiber optic through laryngeal mask AuraGain compared to fiberoptic intubation without laryngeal mask

  immediately after intubation

• Accidental extubation at the time of removing the bronchoscope and/or the laryngeal mask.

  immediately after intubation

• Ease of tracheal intubation

  immediately after intubation

Study Arms (2)

Fiberoptic intubation using laryngeal mask AuraGain

ACTIVE COMPARATOR

Participants should perform an fiberoptic tracheal intubation through the AuraGain laryngeal mask, in a pediatric simulator. Will be evaluated the success rate at the first attempt and other secondary outcomes

Device: Fiberoptic intubation with laryngeal mask AuraGain

Fiberoptic intubation without laryngeal mask

ACTIVE COMPARATOR

Participants should perform an fiberoptic tracheal intubation without laryngeal mask, in a pediatric simulator. Will be evaluated the success rate at the first attempt and other secondary outcomes

Device: Fiberoptic intubation without laryngeal mask

Interventions

Fiberoptic intubation with laryngeal mask AuraGain DEVICE

Participants should perform an fiberoptic tracheal intubation through the AuraGain laryngeal mask, in a pediatric simulator.

Fiberoptic intubation using laryngeal mask AuraGain

Fiberoptic intubation without laryngeal mask DEVICE

Participants should perform an fiberoptic tracheal intubation without laryngeal mask, in a pediatric simulator.

Fiberoptic intubation without laryngeal mask

Eligibility Criteria

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

You may qualify if:

• Anesthesiologists or anesthesiology residents
• Perform a training in fiber optic tracheal intubation whit and without supraglottic device in simulators. The CUSUM learning curve will be used to achieve a success rate greater than 80% at the first attempt.
• Accept to participate in the study and sign the informed consent

Sponsors & Collaborators

• Universidad de Antioquia: lead

Study Sites (2)

Mario Andres Zamudio

Medellín, Antioquia, Colombia

Location

Antioquia´s University

Medellín, Colombia

Location

MeSH Terms

Interventions

Laryngeal Masks

Intervention Hierarchy (Ancestors)

Intubation, Intratracheal; Airway Management; Therapeutics; Intubation; Investigative Techniques; Masks; Protective Devices; Equipment and Supplies; Personal Protective Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Mario A Zamudio, Professor

  Universidad de Antioquia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: The study will be a controlled, cross-sectional, randomized, non-blind, superiority trial and will be realized in a simulation center, with pediatric manikins. It includes 41 anesthesiologists or anesthesiology residents, who will be randomized to start their participation in the clinical trial in the intervention or control group. Subsequently, they will become part of the opposing group.

Study Record Dates

• First Submitted: February 5, 2020
• First Posted: April 22, 2020
• Study Start: September 15, 2020
• Primary Completion: March 15, 2021
• Study Completion: March 15, 2021
• Last Updated: May 5, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 5 years
• Access Criteria: Formal application and authorization of the University of Antioquia

Locations

CO (2)