Sequential Strategy vs Palpation vs Routine Ultrasound for Detection of Cricothyroid Membrane

Study Overview
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Brief Summary
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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
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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 &gt; 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

Official Title
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Sequential Strategy of Palpation Plus Ultrasound vs Palpation vs Routine Ultrasound , in Adults for Detection of Cricothyroid Membrane: Protocol of an Adaptive Controlled Randomized Clinical Trial

Conditions
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Airway Disease, Intubation; Difficult or Failed, Ultrasound Therapy

Intervention / Treatment
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* Diagnostic Test: Palpation with  laryngeal handshake technique
* Diagnostic Test: Palpation strategy plus sequential ultrasound
* Diagnostic Test: Identification of the cricothyroid membrane with routine ultrasound


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Palpation with  laryngeal handshake technique <br>With the non-dominant hand, the larynx is stabilized, the hyoid bone is identified with the thumb and index finger by palpation of the greater horns with a horizontal movement from side to side, move thumb and fingers inferiorly to locate thyroid cartilage,Once identified, its location is maintained with the middle finger and thumb, and the index finger travels towards the midline. The index finger, already in the midline, makes a longitudinal movement downwards to determine the small depression between the cricoid and thyroid cartilage that corresponds to the cricothyroid membrane. | Diagnostic Test: Palpation with  laryngeal handshake technique<br>* Information alredy included<br>|
| Experimental: Palpation strategy plus sequential ultrasound<br>Palpation is performed with the previously described laryngeal handshake technique If the participant is unable to identify the location of the cricothyroid membrane with certainty, the mixed ultrasound protocol is continued. as decribed in Identification of the cricothyroid membrane with ultrasound | Diagnostic Test: Palpation strategy plus sequential ultrasound<br>* Information alredy included<br>|
| Active Comparator: Identification of the cricothyroid membrane with routine ultrasound<br>With the patient on a supine stretcher position, neck extended, with a linear transducer and ultrasound gel, a cross-sectional evaluation of the airway is performed, identifying the cartilaginous referents of the airway. In this case, the midline referent will be the union of the laminae of the thyroid cartilage. The midpoint of the hyperechoic image is located between both referents (MCT). Next, tracheal rings are identified, the transducer is moved laterally and a 90° turn is performed for axial evaluation of the MCT. The aim is to preserve the same anatomical landmarks already identified in the transverse plane, the cephalocaudal distance between the thyroid cartilage and the cricoid is evaluated, locating the midpoint with the help of the acoustic shadow generated by a yelco without a needle. Based on these 2 measurements, the topographical location of the MCT will be marked with a visible ink marker under UV light, which will serve as a benchmark for comparison. | Diagnostic Test: Identification of the cricothyroid membrane with routine ultrasound<br>* Information alredy included<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of adequate cricothyroid membrane identification by group | 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%. | through study completion, an average of 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of difficulty | 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. | 30 minutes | 
| Time to detection | 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 | through study completion, an average of 10 minutes | 
| Longitudinal deviation | 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. | through study completion, an average of 10 minutes | 
| Lateral deviation in mm | 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. | through study completion, an average of 10 minutes | 
| Participant satisfaction | 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. | through study completion, an average of 10 minutes | 
| Satisfaction of the administrators of the intervention | 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. | through study completion, an average of 10 minutes | 
| Perception of adherence to the technique | 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 | through study completion, an average of 10 minutes |