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

NCT05535127 | Unknown

• 1 other identifier: IN78-2021
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 1

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.

Conditions

Airway Disease; Intubation; Difficult or Failed; Ultrasound Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Degree of difficulty

  30 minutes

• Time to detection

  through study completion, an average of 10 minutes

• Longitudinal deviation

  through study completion, an average of 10 minutes

• Lateral deviation in mm

  through study completion, an average of 10 minutes

• Participant satisfaction

  through study completion, an average of 10 minutes

Study Arms (3)

Palpation with " laryngeal handshake" technique "

ACTIVE COMPARATOR

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

Palpation strategy plus sequential ultrasound

EXPERIMENTAL

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

Identification of the cricothyroid membrane with routine ultrasound

ACTIVE COMPARATOR

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

Interventions

Palpation with " laryngeal handshake" technique DIAGNOSTIC_TEST

Information alredy included

Palpation with " laryngeal handshake" technique "

Palpation strategy plus sequential ultrasound DIAGNOSTIC_TEST

Information alredy included

Palpation strategy plus sequential ultrasound

Identification of the cricothyroid membrane with routine ultrasound DIAGNOSTIC_TEST

Information alredy included

Identification of the cricothyroid membrane with routine ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Older than 18 years-old.
• Acceptance of participation in the clinical study
• Informed consent signature
• Hopitalizated

You may not qualify if:

• Patients with tracheostomy or other ventilation devices in the cervical region

Sponsors & Collaborators

• Universidad de Antioquia: lead

Study Sites (1)

Antioquia´s University

Medellín, Colombia

Location

Related Publications (4)

• 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.

  PMID: 34143394 BACKGROUND

• 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.

  PMID: 32836091 BACKGROUND

• 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.

  PMID: 2976186 BACKGROUND

• 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.

  PMID: 31297781 BACKGROUND

MeSH Terms

Interventions

Palpation

Intervention Hierarchy (Ancestors)

Physical Examination; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Mario A Zamudio, Prof

  mario.zamudio@udea.edu.co

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mario A Zamudio, Prof

CONTACT

3003456596; mario.zamudio@udea.edu.co

Alejandra Bedoya, Md

CONTACT

3185230182; alejandra.bedoyau@udea.edu.co

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: September 10, 2022
• Study Start: September 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: April 1, 2023
• Last Updated: September 10, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)