Airway DiseaseEcoIDNCT05535127
Sequential Strategy vs Palpation vs Routine Ultrasound for Detection of Cricothyroid Membrane
A study testing Palpation with " laryngeal handshake" technique, Palpation strategy plus sequential ultrasound and Identification of the cricothyroid membrane with routine ultrasound in people with Airway Disease and Intubation; Difficult or Failed, run by Universidad de Antioquia at 1 site in Colombia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Airway Disease, Intubation; Difficult or Failed, Ultrasound Therapy
- What is being tested?
- Palpation with " laryngeal handshake" technique, Palpation strategy plus sequential ultrasound and Identification of the cricothyroid membrane with routine ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 1 siteColombia
- Study dates
- Sep 2022to Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older than 18 years-old.
- Acceptance of participation in the clinical study
- Informed consent signature
- Hopitalizated
Who cannot join
- Patients with tracheostomy or other ventilation devices in the cervical region
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Palpation with " laryngeal handshake" technique, Palpation strategy plus sequential ultrasound, Identification of the cricothyroid membrane with routine ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palpation with " laryngeal handshake" techniqueDiagnostic test
Information alredy included
Palpation strategy plus sequential ultrasoundDiagnostic test
Information alredy included
Identification of the cricothyroid membrane with routine ultrasoundDiagnostic test
Information alredy included
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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. Receives: Diagnostic Test: Identification of the cricothyroid membrane with routine ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: through study completion, an average of 30 minutes
Secondary outcomes (7)
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: through study completion, an average of 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study startSep 2022 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Airway DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 258 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Antioquia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mario A Zamudio, Prof, Principal investigator, mario.zamudio@udea.edu.co
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05535127
- Sponsor's protocol ID
- IN78-2021
- Acronym
- EcoID
- Status last verified
- Mar 2022
- First submitted
- 11 May 2022
- Last updated
- 10 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: public deposit
Publications
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.
PubMed 34143394Rai 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.
PubMed 32836091Zanetti 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.
PubMed 2976186Altun 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.
PubMed 31297781
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05535127
- Acronym / sponsor ID
- EcoID / IN78-2021
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 258 participants (estimated)
- Lead sponsor
- Universidad de AntioquiaUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 10 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Palpation with " laryngeal handshake" technique " | Active comparator | Diagnostic Test: Palpation with " laryngeal handshake" techniqueWith 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. |
| Palpation strategy plus sequential ultrasound | Experimental | Diagnostic Test: Palpation strategy plus sequential ultrasoundPalpation 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 |
| Identification of the cricothyroid membrane with routine ultrasound | Active comparator | Diagnostic Test: Identification of the cricothyroid membrane with routine ultrasoundWith 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Older than 18 years-old.
- Acceptance of participation in the clinical study
- Informed consent signature
- Hopitalizated
Key exclusion criteria (1 listed)
- Patients with tracheostomy or other ventilation devices in the cervical region
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Palpation with " laryngeal handshake" techniqueInformation alredy included | Diagnostic test | Palpation with " laryngeal handshake" technique " |
| Palpation strategy plus sequential ultrasoundInformation alredy included | Diagnostic test | Palpation strategy plus sequential ultrasound |
| Identification of the cricothyroid membrane with routine ultrasoundInformation alredy included | Diagnostic test | Identification of the cricothyroid membrane with routine ultrasound |
Primary outcome
Proportion of adequate cricothyroid membrane identification by group
Time frame: through study completion, an average of 30 minutes
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%.
7 secondary outcomes
Degree of difficulty
Time frame: 30 minutes
Time to detection
Time frame: through study completion, an average of 10 minutes
Longitudinal deviation
Time frame: through study completion, an average of 10 minutes
Lateral deviation in mm
Time frame: through study completion, an average of 10 minutes
Participant satisfaction
Time frame: through study completion, an average of 10 minutes
Satisfaction of the administrators of the intervention
Time frame: through study completion, an average of 10 minutes
Perception of adherence to the technique
Time frame: through study completion, an average of 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2022.
- Background: PubMed 34143394Law 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.
- Background: PubMed 32836091Rai 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.
- Background: PubMed 2976186Zanetti 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.
- Background: PubMed 31297781Altun 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.
- Individual participant dataSharing planned: No. public deposit
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mario A Zamudio, Prof principal investigator
mario.zamudio@udea.edu.co
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palpation with " laryngeal handshake" technique, Palpation strategy plus sequential ultrasound and Identification of the cricothyroid membrane with routine ultrasound in people with Airway Disease and Intubation; Difficult or Failed, run by Universidad de Antioquia at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mario A Zamudio, Prof (3003456596, mario.zamudio@udea.edu.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of adequate cricothyroid membrane identification by group (time frame: through study completion, an average of 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05535127, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2022.