Orotracheal Intubation Using Flexible Fibro Bronchoscope With vs Without Supraglottic Device AuraGain in Pediatric Simulators: Cross Over Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Universidad de Antioquia
- Enrollment
- 41
- Locations
- 2
- Primary Endpoint
- Successful intubation at the first attempt using fiber optic through laryngeal mask AuraGain compared to fiberoptic intubation without laryngeal mask
Study Overview
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.
Detailed Description
To determine the required sample size, the data reported from studies were studied where the Auragain device for intubation with fibrobronchoscope in adult patients is studied. In these studies, an average intubation rate at the first attempt in adults of 87% of all cases was found compared to an average success rate of intubation with FBC without a supraglottic device of 60%. Based on these data, and assuming an alpha error of 0.05 of two tails and a power of 80%, a total number of participants of 82 is required, that is 41 participants per group. However, being a cross study, a total of 41 participants is required since each participant will be their own control. For its calculation, the Stata 14.0 program was used Sample size
Recruitment The recruitment of participants will be carried out by the research group. A verbal and email invitation will be made to the anesthesiology residents from different University centers, in addition to the residents of this same specialty of other institutions that are doing some rotation at the University Hospital San Vicente Foundation or IPS University Clinic León XIII. In the same way the anesthesiologists of these two health institutions will be recruited for the study.
Sampling will be carried out for the convenience of consecutive participants until the necessary number is fulfilled according to the sample design.
After this, the possible participants of the clinical trial will be asked about their intention to be part of the study, and those interested will be explained the relevant aspects of this study, including the protocol, objectives, safety aspects and doubts will be resolved.
Once they accept their participation in the clinical trial, the eligibility criteria to enter the study will be determined and it will be remembered that they must perform a CUSUM learning curve for fibrobronchoscopy in pediatric simulators. If the participant accepts the informed consent, authorizing the proceeding of the study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •Not meet the inclusion criteria
Outcomes
Primary Outcomes
Successful intubation at the first attempt using fiber optic through laryngeal mask AuraGain compared to fiberoptic intubation without laryngeal mask
Time Frame: immediately after intubation
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.
Secondary Outcomes
- 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)
- Degree of glottic visualization(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)
- Time required to achieve tracheal intubation using fiber optic through laryngeal mask AuraGain compared to fiberoptic intubation without laryngeal mask(immediately after intubation)
Investigators
Mario Zamudio
Clinical Professor
Universidad de Antioquia