Airway Disease, Intubation; Difficult or Failed, Ultrasound Therapy
Conditions
Brief summary
EcoID is a study designed as an adaptive controlled clinical trial with a first phase of superiority and a second phase of non-inferiority with change of control, of parallel groups, random assignment and blinding of investigators measuring outcome.
Detailed description
Methodology: Methods, techniques and tools provided. Describe the design, study population, materials, procedures and analysis plan: EcoID is a study designed as an adaptive controlled clinical trial with a first phase of superiority and a second phase of non-inferiority with change of control, of parallel groups, random assignment and blinding of investigators measuring outcome. A Bayesian statistical approach will be used for the analysis and inferences of the information obtained from the clinical trial. The use of an adaptive study is justified given that there is uncertainty if the sequential strategy is superior to palpation, so performing the sequential experiment optimizes sample collection. In case the intervention does not pass phase 1, it is not necessary to expose more patients to compare the intervention by the second control. By using a Bayesian statistical approach, it is possible to use the phase 1 sample as a prior probability distribution. Therefore, the adaptive sample of phase 2 is optimized, achieving the best statistical performance with the least amount of time and resources, benefits found in this type of design The study population will be adult patients of the IPS Universitaria, who accept participation in the study and sign the informed consent. In phase 1 of the study, a comparison will be made between identification of the MCT by palpation and the intervention of identification by the sequential strategy of palpation plus ultrasound, this consists of an assessment by palpation and in the event that the participant is not sure in the identification advances in ultrasound assessment. A sample of 129 patients is calculated for each arm. The superiority of the intervention over palpatory control will be assessed, only if this superiority is demonstrated will advance to phase 2. For phase 2, a comparison will be made between identification of the MCT by routine ultrasound and the intervention of identification by the strategy sequential palpation plus ultrasound. The sample will be calculated based on the results of the first phase, the hypothesis will be to demonstrate that this intervention strategy is not inferior to routine ultrasound. The accuracy of the controls and the intervention will be compared against the ultrasound identification of an airway expert with a CUSUM curve greater than 90%. Materials: * Training activities both in MCT identification strategy by palpation with the laryngeal handshake technique, routine ultrasound to achieve a CUSUM curve > 80% in the participants and training in the sequential strategy. * Mindray M9 ultrasound scanner with linear probe without needle * Yelco gel -Chronometer * UV visible ink marker -Black ink marker
Interventions
DIAGNOSTIC_TESTPalpation with laryngeal handshake technique
Information alredy included
DIAGNOSTIC_TESTPalpation strategy plus sequential ultrasound
Information alredy included
DIAGNOSTIC_TESTIdentification of the cricothyroid membrane with routine ultrasound
Information alredy included
Sponsors
Universidad de Antioquia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Older than 18 years-old. * Acceptance of participation in the clinical study * Informed consent signature * Hopitalizated
Exclusion criteria
* Patients with tracheostomy or other ventilation devices in the cervical region
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of adequate cricothyroid membrane identification by group | through study completion, an average of 30 minutes | Adequate Identification of the cricothyroid membrane For the present study, it is defined as the concordance between the marking performed by any of the interventions and the marking performed by an expert. This must have a distance of less than 5 mm both in the axial and longitudinal planes. An expert in the field is defined as a professional who works using advanced airway management strategies, and has published on airway ultrasonography and/or performs a CUSUM curve for MCT identification \>90%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to detection | through study completion, an average of 10 minutes | Defined as the time from the first contact with the patient by the administrator of the intervention, until the marking of the cricothyroid membrane with any of the interventions |
| Longitudinal deviation | through study completion, an average of 10 minutes | Defined as the distance in millimeters between the marking made by the administrator of the intervention and the expert evaluator of the outcome in the lateral plane. |
| Lateral deviation in mm | through study completion, an average of 10 minutes | Defined as the distance in millimeters between the marking made by the administrator of the intervention and the expert evaluator of the outcome in the lateral plane. |
| Degree of difficulty | 30 minutes | perceived by evaluators in the identification of the cricothyroid membrane: It is understood as the perception of difficulty of each intervention by the administrators of the intervention. |
| Satisfaction of the administrators of the intervention | through study completion, an average of 10 minutes | Defined as the global perception of satisfaction with the technique by the participants administering the intervention. For this measurement, a global Likert-type scale will be used, whose score ranges between 1 and 7, with 1 being very dissatisfied and 7 being very satisfied. |
| Perception of adherence to the technique | through study completion, an average of 10 minutes | Defined as the global perception of future use of the technique by the administrators of the intervention. For this measurement, a Likert-type global scale will be used, whose score ranges between 1 and 7, with 1 being a very poor perception of use in the future and 7 being a very high perception of use in the future |
| Participant satisfaction | through study completion, an average of 10 minutes | Defined as the patients' global perception of satisfaction with the technique. For this measurement, a global Likert-type scale will be used, whose score ranges between 1 and 7, with 1 being very dissatisfied and 7 being very satisfied. |
Countries
Colombia
Contacts
Primary ContactMario A Zamudio, Prof
Backup ContactAlejandra Bedoya, Md
Outcome results
None listed