Cardiac ArrestNCT05859516
Application of Point-of-care Ultrasound in Rapid Assessment of Cardiac Arrest Patients
An observational study of Cardiac Arrest and Point-of-care Ultrasound, run by Zhongnan Hospital at 1 site in China.
Trial summary
To quickly assess the patient's cardiac function and structure through ultrasound Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest, Point-of-care Ultrasound, Cardiopulmonary Resuscitation
- What is being tested?
- Ultrasound
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2023to 30 Jun 2024
- Phase
- Observational
- 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
Study population: Emergency Department patients
Who may be able to join
- Voluntarily participate and sign a written informed consent;
- Male or female above 18;
- Patients who are sent to the emergency room of our hospital with symptoms of "cardiopulmonary resuscitation";
Who cannot join
- There is trauma in the ultrasound examination site and it is not suitable for ultrasound examination;
- Entering the emergency room without vital signs for more than 30 minutes;
- The appearance of corpse corpses;
- There is life-threatening and irreversible damage;
- Other investigators consider it inappropriate and the patient or family member refuses;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430000
Hao Zou, 18571618123, zouhao@whu.edu.cn
About this study
To quickly assess the patient's cardiac function and structure through ultrasound
Read the detailed description
Monitor the peripheral arterial pulse and flow velocity, monitor the patient's lung and diaphragm muscle movement, monitor the patient's optic nerve sheath and cerebral blood flow, observe the morphology and blood flow of the liver and kidney and other parenchymal organs, Comprehensive evaluation of patient resuscitation quality.
For patients with cardiac arrest undergoing Cardio Pulmonary Resuscitation (CPR), the above monitoring was completed by ultrasound, and compared with the parameters obtained by end-expiratory carbon dioxide (ETCO2) and compression feedback device, to evaluate the feasibility of ultrasound to evaluate the quality of CPR. After the reliability evaluation was completed, parameters were further used to guide CPR quality improvement through ultrasound, end-expiratory carbon dioxide (ETCO2), and compression feedback device.
- Being tested
- Ultrasound
- Keywords
- Cardiac Arrest, Point-of-care Ultrasound, cardiopulmonary resuscitation quality
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDiagnostic test
Every time checking pulse, evaluate the carotid artery compressibility and blood flow of peripheral arteries by ultrasound，compared with EtCO2.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Ultrasound | Not described Receives: Diagnostic Test: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
The correlation between return of spontaneous circulation rate and peripheral blood flow through study completion, an average of 1 hour.
For patients with cardiac arrest undergoing CPR, Peripheral arterial blood flow monitoring was completed by ultrasound, and compared with treturn of spontaneous circulation rate .
Bilateral carotid blood flow velocity:
- Peak systolic velocity, PSV, cm/s
- End diastolic velocity, EDV,cm/s
- Resistance index, RI
- Pulsatility index, PI Bilateral femoral artery blood flow velocity
- Peak systolic velocity, PSV, cm/s 2) End diastolic velocity, EDV,cm/s 3) Resistance index, RI 4) Pulsatility index, P
Measured: through study completion, an average of 1 hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start1 Feb 2023
- Primary completion31 Jan 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongnan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jian Xia, Dr., Principal investigator, Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05859516
- Sponsor's protocol ID
- 2022003
- Status last verified
- Sep 2022
- First submitted
- 24 Mar 2023
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pandor A, Fuller G, Essat M, Sabir L, Holt C, Buckley Woods H, Chatha H. Individual risk factors predictive of major trauma in pre-hospital injured older patients: a systematic review. Br Paramed J. 2022 Mar 1;6(4):26-40. doi: 10.29045/14784726.2022.03.6.4.26.
PubMed 35340581Mederos MA, Reber HA, Girgis MD. Acute Pancreatitis: A Review. JAMA. 2021 Jan 26;325(4):382-390. doi: 10.1001/jama.2020.20317.
PubMed 33496779Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
PubMed 26903338Reynolds JC, Nicholson T, O'Neil B, Drennan IR, Issa M, Welsford M; Advanced Life Support Task Force at the International Liaison Committee on Resuscitation ILCOR. Diagnostic test accuracy of point-of-care ultrasound during cardiopulmonary resuscitation to indicate the etiology of cardiac arrest: A systematic review. Resuscitation. 2022 Mar;172:54-63. doi: 10.1016/j.resuscitation.2022.01.006. Epub 2022 Jan 19.
PubMed 35065210Montoya J, Stawicki SP, Evans DC, Bahner DP, Sparks S, Sharpe RP, Cipolla J. From FAST to E-FAST: an overview of the evolution of ultrasound-based traumatic injury assessment. Eur J Trauma Emerg Surg. 2016 Apr;42(2):119-26. doi: 10.1007/s00068-015-0512-1. Epub 2015 Mar 14.
PubMed 26038031Keikha M, Salehi-Marzijarani M, Soldoozi Nejat R, Sheikh Motahar Vahedi H, Mirrezaie SM. Diagnostic Accuracy of Rapid Ultrasound in Shock (RUSH) Exam; A Systematic Review and Meta-analysis. Bull Emerg Trauma. 2018 Oct;6(4):271-278. doi: 10.29252/beat-060402.
PubMed 30402514Dicker SA. Lung Ultrasound for Pulmonary Contusions. Vet Clin North Am Small Anim Pract. 2021 Nov;51(6):1141-1151. doi: 10.1016/j.cvsm.2021.07.001. Epub 2021 Sep 11.
PubMed 34521570Lichtenstein D. Fluid administration limited by lung sonography: the place of lung ultrasound in assessment of acute circulatory failure (the FALLS-protocol). Expert Rev Respir Med. 2012 Apr;6(2):155-62. doi: 10.1586/ers.12.13.
PubMed 22455488Kang SY, Jo IJ, Lee G, Park JE, Kim T, Lee SU, Hwang SY, Shin TG, Kim K, Shim JS, Yoon H. Point-of-care ultrasound compression of the carotid artery for pulse determination in cardiopulmonary resuscitation. Resuscitation. 2022 Oct;179:206-213. doi: 10.1016/j.resuscitation.2022.06.025. Epub 2022 Jul 2.
PubMed 35792305Sheak KR, Wiebe DJ, Leary M, Babaeizadeh S, Yuen TC, Zive D, Owens PC, Edelson DP, Daya MR, Idris AH, Abella BS. Quantitative relationship between end-tidal carbon dioxide and CPR quality during both in-hospital and out-of-hospital cardiac arrest. Resuscitation. 2015 Apr;89:149-54. doi: 10.1016/j.resuscitation.2015.01.026. Epub 2015 Jan 30.
PubMed 25643651Genbrugge C, Dens J, Meex I, Boer W, Eertmans W, Sabbe M, Jans F, De Deyne C. Regional Cerebral Oximetry During Cardiopulmonary Resuscitation: Useful or Useless? J Emerg Med. 2016 Jan;50(1):198-207. doi: 10.1016/j.jemermed.2015.03.043. Epub 2015 Sep 26.
PubMed 26412107Reynolds JC, Issa MS, C Nicholson T, Drennan IR, Berg KM, O'Neil BJ, Welsford M; Advanced Life Support Task Force of the International Liaison Committee on Resuscitation. Prognostication with point-of-care echocardiography during cardiac arrest: A systematic review. Resuscitation. 2020 Jul;152:56-68. doi: 10.1016/j.resuscitation.2020.05.004. Epub 2020 May 11.
PubMed 32437781Kedan I, Ciozda W, Palatinus JA, Palatinus HN, Kimchi A. Prognostic value of point-of-care ultrasound during cardiac arrest: a systematic review. Cardiovasc Ultrasound. 2020 Jan 13;18(1):1. doi: 10.1186/s12947-020-0185-8.
PubMed 31931808
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Point-of-care Ultrasound in Rapid Assessment of Cardiac Arrest Patients
- ClinicalTrials.gov ID
- NCT05859516
- Acronym / sponsor ID
- 2022003
- Keywords
- Cardiac Arrest, Point-of-care Ultrasound, cardiopulmonary resuscitation quality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Zhongnan HospitalUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 16 May 2023 (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.
To quickly assess the patient's cardiac function and structure through ultrasound
Detailed description
Monitor the peripheral arterial pulse and flow velocity, monitor the patient's lung and diaphragm muscle movement, monitor the patient's optic nerve sheath and cerebral blood flow, observe the morphology and blood flow of the liver and kidney and other parenchymal organs, Comprehensive evaluation of patient resuscitation quality.
For patients with cardiac arrest undergoing Cardio Pulmonary Resuscitation (CPR), the above monitoring was completed by ultrasound, and compared with the parameters obtained by end-expiratory carbon dioxide (ETCO2) and compression feedback device, to evaluate the feasibility of ultrasound to evaluate the quality of CPR. After the reliability evaluation was completed, parameters were further used to guide CPR quality improvement through ultrasound, end-expiratory carbon dioxide (ETCO2), and compression feedback device.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Ultrasound | – | Diagnostic Test: Ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Emergency Department patients
Key inclusion criteria (3 listed)
- Voluntarily participate and sign a written informed consent;
- Male or female above 18;
- Patients who are sent to the emergency room of our hospital with symptoms of "cardiopulmonary resuscitation";
Key exclusion criteria (5 listed)
- There is trauma in the ultrasound examination site and it is not suitable for ultrasound examination;
- Entering the emergency room without vital signs for more than 30 minutes;
- The appearance of corpse corpses;
- There is life-threatening and irreversible damage;
- Other investigators consider it inappropriate and the patient or family member refuses;
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 |
|---|---|---|
| UltrasoundEvery time checking pulse, evaluate the carotid artery compressibility and blood flow of peripheral arteries by ultrasound，compared with EtCO2. | Diagnostic test | Experimental: Ultrasound |
Primary outcome
The correlation between return of spontaneous circulation rate and peripheral blood flow through study completion, an average of 1 hour.
Time frame: through study completion, an average of 1 hour.
For patients with cardiac arrest undergoing CPR, Peripheral arterial blood flow monitoring was completed by ultrasound, and compared with treturn of spontaneous circulation rate . Bilateral carotid blood flow velocity: 1. Peak systolic velocity, PSV, cm/s 2. End diastolic velocity, EDV,cm/s 3. Resistance index, RI 4. Pulsatility index, PI Bilateral femoral artery blood flow velocity 1) Peak systolic velocity, PSV, cm/s 2) End diastolic velocity, EDV,cm/s 3) Resistance index, RI 4) Pulsatility index, P
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Background: PubMed 35340581Pandor A, Fuller G, Essat M, Sabir L, Holt C, Buckley Woods H, Chatha H. Individual risk factors predictive of major trauma in pre-hospital injured older patients: a systematic review. Br Paramed J. 2022 Mar 1;6(4):26-40. doi: 10.29045/14784726.2022.03.6.4.26.
- Background: PubMed 33496779Mederos MA, Reber HA, Girgis MD. Acute Pancreatitis: A Review. JAMA. 2021 Jan 26;325(4):382-390. doi: 10.1001/jama.2020.20317.
- Background: PubMed 26903338Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
- Background: PubMed 35065210Reynolds JC, Nicholson T, O'Neil B, Drennan IR, Issa M, Welsford M; Advanced Life Support Task Force at the International Liaison Committee on Resuscitation ILCOR. Diagnostic test accuracy of point-of-care ultrasound during cardiopulmonary resuscitation to indicate the etiology of cardiac arrest: A systematic review. Resuscitation. 2022 Mar;172:54-63. doi: 10.1016/j.resuscitation.2022.01.006. Epub 2022 Jan 19.
- Background: PubMed 26038031Montoya J, Stawicki SP, Evans DC, Bahner DP, Sparks S, Sharpe RP, Cipolla J. From FAST to E-FAST: an overview of the evolution of ultrasound-based traumatic injury assessment. Eur J Trauma Emerg Surg. 2016 Apr;42(2):119-26. doi: 10.1007/s00068-015-0512-1. Epub 2015 Mar 14.
- Background: PubMed 30402514Keikha M, Salehi-Marzijarani M, Soldoozi Nejat R, Sheikh Motahar Vahedi H, Mirrezaie SM. Diagnostic Accuracy of Rapid Ultrasound in Shock (RUSH) Exam; A Systematic Review and Meta-analysis. Bull Emerg Trauma. 2018 Oct;6(4):271-278. doi: 10.29252/beat-060402.
- Background: PubMed 34521570Dicker SA. Lung Ultrasound for Pulmonary Contusions. Vet Clin North Am Small Anim Pract. 2021 Nov;51(6):1141-1151. doi: 10.1016/j.cvsm.2021.07.001. Epub 2021 Sep 11.
- Background: PubMed 22455488Lichtenstein D. Fluid administration limited by lung sonography: the place of lung ultrasound in assessment of acute circulatory failure (the FALLS-protocol). Expert Rev Respir Med. 2012 Apr;6(2):155-62. doi: 10.1586/ers.12.13.
- Background: PubMed 35792305Kang SY, Jo IJ, Lee G, Park JE, Kim T, Lee SU, Hwang SY, Shin TG, Kim K, Shim JS, Yoon H. Point-of-care ultrasound compression of the carotid artery for pulse determination in cardiopulmonary resuscitation. Resuscitation. 2022 Oct;179:206-213. doi: 10.1016/j.resuscitation.2022.06.025. Epub 2022 Jul 2.
- Background: PubMed 25643651Sheak KR, Wiebe DJ, Leary M, Babaeizadeh S, Yuen TC, Zive D, Owens PC, Edelson DP, Daya MR, Idris AH, Abella BS. Quantitative relationship between end-tidal carbon dioxide and CPR quality during both in-hospital and out-of-hospital cardiac arrest. Resuscitation. 2015 Apr;89:149-54. doi: 10.1016/j.resuscitation.2015.01.026. Epub 2015 Jan 30.
- Background: PubMed 26412107Genbrugge C, Dens J, Meex I, Boer W, Eertmans W, Sabbe M, Jans F, De Deyne C. Regional Cerebral Oximetry During Cardiopulmonary Resuscitation: Useful or Useless? J Emerg Med. 2016 Jan;50(1):198-207. doi: 10.1016/j.jemermed.2015.03.043. Epub 2015 Sep 26.
- Background: PubMed 32437781Reynolds JC, Issa MS, C Nicholson T, Drennan IR, Berg KM, O'Neil BJ, Welsford M; Advanced Life Support Task Force of the International Liaison Committee on Resuscitation. Prognostication with point-of-care echocardiography during cardiac arrest: A systematic review. Resuscitation. 2020 Jul;152:56-68. doi: 10.1016/j.resuscitation.2020.05.004. Epub 2020 May 11.
- Individual participant dataSharing planned: No
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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.
Jian Xia, Dr. principal investigator
Wuhan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest and Point-of-care Ultrasound, run by Zhongnan Hospital at 1 site in China.
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 3 inclusion and 5 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 16 May 2023. 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 China. 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 Hao Zou, Dr. (86-27-67813337, zouhao@whu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The correlation between return of spontaneous circulation rate and peripheral blood flow through study completion, an average of 1 hour. (time frame: through study completion, an average of 1 hour.). 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 NCT05859516, which also lists 13 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 16 May 2023.