Clinical trial NCT05535127: Sequential Strategy vs Palpation vs Routine Ultrasound for Detection of Cricothyroid Membrane
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Airway Disease
Intubation; Difficult or Failed
Ultrasound Therapy
Lead sponsor: Universidad de Antioquia
Sponsor class: OTHER
First posted: 2022-09-10
Enrollment: 258
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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 \&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

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of adequate cricothyroid membrane identification by group
timeFrame: through study completion, an average of 30 minutes
Secondary outcomes:
measure: Degree of difficulty
timeFrame: 30 minutes
measure: Time to detection
timeFrame: through study completion, an average of 10 minutes
measure: Longitudinal deviation
timeFrame: through study completion, an average of 10 minutes
measure: Lateral deviation in mm
timeFrame: through study completion, an average of 10 minutes
measure: Participant satisfaction
timeFrame: through study completion, an average of 10 minutes
measure: Satisfaction of the administrators of the intervention
timeFrame: through study completion, an average of 10 minutes
measure: Perception of adherence to the technique
timeFrame: through study completion, an average of 10 minutes
Other outcomes:
Locations:
city: Medellin
country: Colombia
facility: Antioquia´s University
Study officials:
affiliation: mario.zamudio@udea.edu.co
name: Mario A Zamudio, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Law JA, Duggan LV, Asselin M, Baker P, Crosby E, Downey A, Hung OR, Jones PM, Lemay F, Noppens R, Parotto M, Preston R, Sowers N, Sparrow K, Turkstra TP, Wong DT, Kovacs G; Canadian Airway Focus Group. Canadian Airway Focus Group updated consensus-based recommendations for management of the difficult airway: part 1. Difficult airway management encountered in an unconscious patient. Can J Anaesth. 2021 Sep;68(9):1373-1404. doi: 10.1007/s12630-021-02007-0. Epub 2021 Jun 18.
citation: Rai Y, You-Ten E, Zasso F, De Castro C, Ye XY, Siddiqui N. The role of ultrasound in front-of-neck access for cricothyroid membrane identification: A systematic review. J Crit Care. 2020 Dec;60:161-168. doi: 10.1016/j.jcrc.2020.07.030. Epub 2020 Aug 13.
citation: Zanetti G, Mandressi A, Ruoppolo M, Montanari E, Pisani E. Infected renal stones and defects of ureteral peristalsis. Arch Ital Urol Nefrol Androl. 1987 Dec;59(2):71-4. No abstract available.
citation: Altun D, Ali A, Koltka K, Buget M, Celik M, Doruk C, Camci AE. Role of ultrasonography in determining the cricothyroid membrane localization in the predicted difficult airway. Ulus Travma Acil Cerrahi Derg. 2019 Jul;25(4):355-360. doi: 10.14744/tjtes.2019.65250.