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

Intubation; Difficult or Failed Clinical Trial

— EcoID  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05535127
• Other study ID #: IN78-2021
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2022
• Est. completion date: April 2023

Study information

• Verified date: March 2022
• Source: Universidad de Antioquia
• Contact: Mario A Zamudio, Prof
• Phone: 3003456596
• Email: mario.zamudio[@]udea.edu.co
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 258
• Est. completion date: April 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• Palpation with " laryngeal handshake" technique
Information alredy included
• Palpation strategy plus sequential ultrasound
Information alredy included
• Identification of the cricothyroid membrane with routine ultrasound
Information alredy included

Locations

Country	Name	City	State
Colombia	Antioquia´s University	Medellin

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Antioquia

Country where clinical trial is conducted

Colombia, 

References & Publications (4)

Altun D, Ali A, Koltka K, Buget M, Çelik M, Doruk C, Çamci 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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