Ultrasound Therapy; ComplicationsNCT02952768
The Novel US-C-A-B Protocol: Curriculum Implementation and Evaluation of Proficiency
A study testing ultrasound training in people with Ultrasound Therapy; Complications, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Ultrasound is a frequently used diagnostic tool in the emergency department and suggested to have a role during resuscitation. The aims of this study were to develop a novel, resuscitative ultrasound-circulation-airway-breathing (US-C-A-B) protocol, to implement a short curriculum and to assess the feasibility. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Ultrasound Therapy; Complications
- What is being tested?
- ultrasound training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2014to Dec 2017
- 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 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The enrolled participants were emergency physicians of the National Taiwan University Hospital (NTUH), the Far-Eastern Memorial Hospital (FEMH) and the Chang-Kung Memorial Hospital (CKMH), three teaching hospitals in Taiwan.
Who cannot join
- Not emergency physicians.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Taiwan, 100
Wan-Ching Lien, Ph.D., 886-2-23123456 ext. 65637, wanchinglien@ntu.edu.tw
About this study
Ultrasound is a frequently used diagnostic tool in the emergency department and suggested to have a role during resuscitation. The aims of this study were to develop a novel, resuscitative ultrasound-circulation-airway-breathing (US-C-A-B) protocol, to implement a short curriculum and to assess the feasibility.
The US-C-A-B protocol was built in an advanced life support-compliant manner. It involved a 3-part assessment: (1) C: subxiphoid 4-chamber view of the heart; (2) A: tracheal ultrasound; and (3) B: bilateral lung sliding. It could be used for direct confirmation for the C-A-B and searching the possible cause of cardiac arrest.
A half-day curriculum was designed, and comprised of one-hour didactics and 3-hour small-group hand-on training. Assessments were performed, including a written test, the US image acquisition and a satisfaction survey. From August 1, 2014 to March 31, 2016, the multi-center emergency physicians who attended the US-C-A-B curricula were enrolled prospectively.
Read the detailed description
Ultrasound is a frequently used diagnostic tool in the emergency department and suggested to have a role during resuscitation. The aims of this study were to develop a novel, resuscitative ultrasound-circulation-airway-breathing (US-C-A-B) protocol, to implement a short curriculum and to assess the feasibility.
The US-C-A-B protocol was built in an advanced life support-compliant manner. It involved a 3-part assessment: (1) C: subxiphoid 4-chamber view of the heart; (2) A: tracheal ultrasound; and (3) B: bilateral lung sliding. It could be used for direct confirmation for the C-A-B and searching the possible cause of
- Conditions
- Ultrasound Therapy; Complications
- Being tested
- ultrasound training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound trainingBehavioural
Through the ultrasound-circulation-airway-breathing training curriculum to integrate the ultrasound into clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| ultrasound training | Other | The aims were to develop a novel, resuscitative ultrasound-circulation-airway-breathing (US-C-A-B) protocol, to implement a short curriculum for ultrasound training and to assess the feasibility. Receives: Behavioral: ultrasound training |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time of the US image acquisition
The 6-month evaluation was performed in cardiac arrest patients. The ultrasound operation time was from the time to initiate the ultrasound exam to when the sonographers to inteprete the results, using the ultrasound recorder.
Measured: 6 months
Secondary outcomes (3)
Learning efficacy was assessed with a written test with 10 multi-choice questions.
The written test with 10 multi-choice questions, including ALS knowledge, and still US image interpretation of C-A-B was performed before and after completion of the course.
Measured: through study completion, an average of 1 year
A satisfaction survey with a 5-point Likert scale.
The post-course satisfaction survey queried the participants in regards to educational value, knowledge acquisition and self-confidence at the end of the course. The survey consisted of 5 items, using a 5-point Likert scale.
Measured: through study completion, an average of 1 year
The time of the US image acquisition
The participants were asked for to produce adequate views of each C-A-B category and consecutive C-A-B exams in the same live model after completion, recorded by the DVD recorder. The time to achieve the views was measured from positioning of the probe on the skin to maintaining an adequate image for at least 3 seconds. The videos were edited that the faces of the participants were covered, and reviewed blindly and independently by the authors. The 6-month evaluation was performed in cardiac arrest patients. The ultrasound operation time was from the time to initiate the ultrasound exam to when the sonographers to inteprete the results, using the ultrasound recorder.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2016 (estimated)
- Study startAug 2014
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultrasound Therapy; ComplicationsStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wan-Ching Lien, Ph.D., Study director, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02952768
- Sponsor's protocol ID
- 201505089RINA
- Status last verified
- Oct 2016
- First submitted
- 26 Oct 2016
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Novel US-C-A-B Protocol: Curriculum Implementation and Evaluation of Proficiency
- ClinicalTrials.gov ID
- NCT02952768
- Acronym / sponsor ID
- 201505089RINA
- Conditions
- Ultrasound Therapy; Complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 2 Nov 2016 (estimated)
- 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.
Ultrasound is a frequently used diagnostic tool in the emergency department and suggested to have a role during resuscitation. The aims of this study were to develop a novel, resuscitative ultrasound-circulation-airway-breathing (US-C-A-B) protocol, to implement a short curriculum and to assess the feasibility.
The US-C-A-B protocol was built in an advanced life support-compliant manner. It involved a 3-part assessment: (1) C: subxiphoid 4-chamber view of the heart; (2) A: tracheal ultrasound; and (3) B: bilateral lung sliding. It could be used for direct confirmation for the C-A-B and searching the possible cause of cardiac arrest.
A half-day curriculum was designed, and comprised of one-hour didactics and 3-hour small-group hand-on training. Assessments were performed, including a written test, the US image acquisition and a satisfaction survey. From August 1, 2014 to March 31, 2016, the multi-center emergency physicians who attended the US-C-A-B curricula were enrolled prospectively.
Detailed description
Ultrasound is a frequently used diagnostic tool in the emergency department and suggested to have a role during resuscitation. The aims of this study were to develop a novel, resuscitative ultrasound-circulation-airway-breathing (US-C-A-B) protocol, to implement a short curriculum and to assess the feasibility.
The US-C-A-B protocol was built in an advanced life support-compliant manner. It involved a 3-part assessment: (1) C: subxiphoid 4-chamber view of the heart; (2) A: tracheal ultrasound; and (3) B: bilateral lung sliding. It could be used for direct confirmation for the C-A-B and searching the possible cause of
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ultrasound training | Other | Behavioral: ultrasound trainingThe aims were to develop a novel, resuscitative ultrasound-circulation-airway-breathing (US-C-A-B) protocol, to implement a short curriculum for ultrasound training and to assess the feasibility. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The enrolled participants were emergency physicians of the National Taiwan University Hospital (NTUH), the Far-Eastern Memorial Hospital (FEMH) and the Chang-Kung Memorial Hospital (CKMH), three teaching hospitals in Taiwan.
Key exclusion criteria (1 listed)
- Not emergency physicians.
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 |
|---|---|---|
| ultrasound trainingThrough the ultrasound-circulation-airway-breathing training curriculum to integrate the ultrasound into clinical practice. | Behavioural | ultrasound training |
Primary outcome
The time of the US image acquisition
Time frame: 6 months
The 6-month evaluation was performed in cardiac arrest patients. The ultrasound operation time was from the time to initiate the ultrasound exam to when the sonographers to inteprete the results, using the ultrasound recorder.
3 secondary outcomes
Learning efficacy was assessed with a written test with 10 multi-choice questions.
Time frame: through study completion, an average of 1 year
A satisfaction survey with a 5-point Likert scale.
Time frame: through study completion, an average of 1 year
The time of the US image acquisition
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Individual participant dataSharing planned: No
Related trials for Ultrasound Therapy; Complications
Not yet recruiting
Low-Dose Norepinephrine With Conservative Fluid Therapy in Hepatobiliary Surgery
Postoperative Complications, Pulmonary Complication
Not yet recruiting
Structured Hemodynamic Assessment to Guide Care After Cardiac Surgery
Cardiac Surgical Procedures, Hemodynamics
Recruiting
Effect of Alcohol Sclerotherapy on Pelvic Pain and Quality of Life in Women With Ovarian Endometriosis
Endometrioma, Ultrasound Therapy; Complications
Not yet recruiting
High Intensity Focused Ultrasound (HIFU) Ablation for Treatment of Prostate Tissue in Bladder Outlet Obstruction
Bladder Outlet Obstruction, BPH
Recruiting
Fluid Balance Guided by Modified Venous Excess Ultrasonography Versus Standard Care in Patients With Acute Kidney Injury Receiving Continuous Renal Replacement Therapy
AKI - Acute Kidney Injury, Fluid Balance
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.
Wan-Ching Lien, Ph.D. study director
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound training in people with Ultrasound Therapy; Complications, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 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 23 Feb 2017. 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 Taiwan. 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 Wan-Ching Lien, Ph. D. (886-2-23123456 ext. 65637, wanchinglien@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time of the US image acquisition (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2017.