Cardiopulmonary ArrestPWMQCNCT01987245
Plethysmographic Waveform for Monitoring the Quality of Cardiopulmonary Resuscitation
An observational study of Cardiopulmonary Arrest and Cardiopulmonary Resuscitation, run by Jun Xu at 1 site in China.
Trial summary
Cardiopulmonary resuscitation(CPR) is the key to success for high-quality early cardiopulmonary resuscitation, and its success in the restoration of spontaneous circulation (ROSC), therefore, monitoring the quality of cardiopulmonary resuscitation and early identification ROSC is very important. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cardiopulmonary Arrest, Cardiopulmonary Resuscitation, Return of Spontaneous Circulation
- How many people
- 617 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Mar 2015
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: emergency room sample of multi-centers
Who may be able to join
- cardiopulmonary arrest, without do-not-resuscitation(DNR) patients
- After cardiac arrest, there is no more than 10 minutes until basic life support.
- must be carried out advanced life support (tracheal intubation and end-tidal carbon dioxide monitoring)
- comply with ethical requirements and signed informed consent
Who cannot join
- DNR patients
- rib fractures
- hemorrhagic shock caused cardiac arrest
- severe anemia, hemoglobin less than 7g/dl
- tension pneumothorax without closed drainage
- pulmonary embolism or pericardial tamponade caused cardiac arrest
Show all 10Show fewer
- onychomycosis
- people who paint fingernails
- clearly influential peripheral oximetry underlying diseases (such as Raynaud's phenomenon, vasculitis)
- The study physicians believe there is any case is not suitable for inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Application Research of Plethysmographic Waveform in Quality Control Feedback System During Cardiopulmonary Resuscitation
Cardiopulmonary resuscitation(CPR) is the key to success for high-quality early cardiopulmonary resuscitation, and its success in the restoration of spontaneous circulation (ROSC), therefore, monitoring the quality of cardiopulmonary resuscitation and early identification ROSC is very important. Now there is no an easy, non-invasive and real-time method to monitor the quality of CPR. In this study the investigators hypothesis the pulse oximeter waveform can real-time monitor the quality of CPR ,and feedback the quality of CPR to the physicians.
- Conditions
- Cardiopulmonary Arrest, Cardiopulmonary Resuscitation, Return of Spontaneous Circulation, Pulse Oximeter Plethysmographic Waveform
- Medical subject headings
- Heart Arrest
What is being measured
The primary outcome is the main question the study is designed to answer.
survival rate
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2013 (estimated)
- Study startJan 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiopulmonary 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
- 617 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jun Xu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jun Xu, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01987245
- Sponsor's protocol ID
- 2013S-512
- Other IDs
- 2011-4001-04
- Acronym
- PWMQC
- Status last verified
- Apr 2015
- First submitted
- 5 Nov 2013
- Last updated
- 29 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Hu Y, Xu J, Zhu H, Zhang G, Sun F, Zhang Y, Yu X. [Profile and outcome of cardiopulmonary resuscitation after sudden cardiac arrests in the emergency department: a multicenter prospective observational study]. Zhonghua Wei Zhong Bing Ji Jiu Yi Xue. 2018 Mar;30(3):234-239. doi: 10.3760/cma.j.issn.2095-4352.2018.03.009. Chinese.
PubMed 29519282
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application Research of Plethysmographic Waveform in Quality Control Feedback System During Cardiopulmonary Resuscitation
- ClinicalTrials.gov ID
- NCT01987245
- Acronym / sponsor ID
- PWMQC / 2013S-512
- Conditions
- Cardiopulmonary Arrest, Cardiopulmonary Resuscitation, Return of Spontaneous Circulation, Pulse Oximeter Plethysmographic Waveform
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 617 participants (actual)
- Lead sponsor
- Jun XuUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 19 Nov 2013 (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.
Cardiopulmonary resuscitation(CPR) is the key to success for high-quality early cardiopulmonary resuscitation, and its success in the restoration of spontaneous circulation (ROSC), therefore, monitoring the quality of cardiopulmonary resuscitation and early identification ROSC is very important. Now there is no an easy, non-invasive and real-time method to monitor the quality of CPR. In this study the investigators hypothesis the pulse oximeter waveform can real-time monitor the quality of CPR ,and feedback the quality of CPR to the physicians.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- emergency room sample of multi-centers
Key inclusion criteria (4 listed)
- cardiopulmonary arrest, without do-not-resuscitation(DNR) patients
- After cardiac arrest, there is no more than 10 minutes until basic life support.
- must be carried out advanced life support (tracheal intubation and end-tidal carbon dioxide monitoring)
- comply with ethical requirements and signed informed consent
Key exclusion criteria (10 listed)
- DNR patients
- rib fractures
- hemorrhagic shock caused cardiac arrest
- severe anemia, hemoglobin less than 7g/dl
- tension pneumothorax without closed drainage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
survival rate
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2015.
- Derived from this study: PubMed 29519282Hu Y, Xu J, Zhu H, Zhang G, Sun F, Zhang Y, Yu X. [Profile and outcome of cardiopulmonary resuscitation after sudden cardiac arrests in the emergency department: a multicenter prospective observational study]. Zhonghua Wei Zhong Bing Ji Jiu Yi Xue. 2018 Mar;30(3):234-239. doi: 10.3760/cma.j.issn.2095-4352.2018.03.009. Chinese.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cardiopulmonary Arrest and Cardiopulmonary Resuscitation, run by Jun Xu 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 4 inclusion and 10 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: finished, as of the sponsor's last update on 29 Apr 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
survival rate (time frame: 4 weeks). 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 NCT01987245, which also lists 1 linked publication.
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 29 Apr 2015.