NCT05535127

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 258 (estimated)
• Sponsor: Universidad de Antioquia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Airway Disease
• Intubation; Difficult or Failed
• Ultrasound Therapy

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Palpation with " laryngeal handshake" technique	Information alredy included
DIAGNOSTIC_TEST	Palpation strategy plus sequential ultrasound	Information alredy included
DIAGNOSTIC_TEST	Identification of the cricothyroid membrane with routine ultrasound	Information alredy included

Timeline

• Start date: 2022-09-01
• Primary completion: 2022-12-01
• Completion: 2023-04-01
• First posted: 2022-09-10
• Last updated: 2022-09-10

Locations

1 site across 1 country: Colombia