Cardiopulmonary ResuscitationNCT03754946
The Critical Threshold of Pulse Oximetry Plethysmographic Waveform Parameters in High Quality CPR
An observational study of Cardiopulmonary Resuscitation, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The purpose of this study is to analyze the relationship of the area under the curve (AUC) and/or the amplitude (Amp) of pulse oximetry plethysmographic waveform (POP) with partial pressure of end-tidal carbon dioxide (PETCO2) which could be used to reflect its quality in cardiopulmonary resuscitation (CPR), and then… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cardiopulmonary Resuscitation
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2015to 31 Dec 2018
- 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: Patients who were admitted to the participant hospitals and met the inclusion criteria were included in the study.
Who may be able to join
- Cardiac arrested
- The time from cardiac arrest to receiving basic life support is less than 10 minutes
- Get advanced life support (endotracheal intubation and PETCO2 monitoring)
Who cannot join
- Defuse CPR
- chronic obstructive pulmonary disease (COPD) with type II respiratory failure
- Terminal malignant tumors or terminal stage of other diseases
- Rib fracture
- Cardiac arrest caused by hemorrhagic shock pulmonary embolism and cardiac tamponade
- Sever anemia(HGB<7g/dl)
- Untreated tension pneumothorax
- Tinea unguium, dyeing Fingernails and other factors affect the monitor of Pulse Oximetry Plethysmographic Waveform such vasculitis and Raynaud's phenomenon
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, 100730
Jun Xu, M.D., 15801578819, xujunfree@126.com
Feng Sun, M.D., 18120102816, sunfeng2016@qq.com
About this study
The purpose of this study is to analyze the relationship of the area under the curve (AUC) and/or the amplitude (Amp) of pulse oximetry plethysmographic waveform (POP) with partial pressure of end-tidal carbon dioxide (PETCO2) which could be used to reflect its quality in cardiopulmonary resuscitation (CPR), and then to determine the critical threshold of POP parameters in high quality CPR.
- Conditions
- Cardiopulmonary Resuscitation
- Keywords
- cardiopulmonary resuscitation, pulse oximetry plethysmographic waveform, quality monitor, partial pressure of end-tidal carbon dioxide
What is being measured
The primary outcome is the main question the study is designed to answer.
the cut-off value of POP parameters in High Quality CPR
Describe the the cut-off value of POP parameters in High Quality CPR. Receiver operating curve analysis was performed to evaluate the accuracy in predicting return of spontaneous circulation (ROSC).
Measured: one year
Compare different predictors
Area under curve (AUC) between potential predictors was compared by using a nonparametric test, and the optimal cutoff point was determined by estimating the Youden's index.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start1 Sep 2015
- Primary completion30 Jun 2018
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiopulmonary ResuscitationStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03754946
- Sponsor's protocol ID
- 201502019
- Status last verified
- Nov 2018
- First submitted
- 15 Nov 2018
- Last updated
- 27 Nov 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Critical Threshold of Pulse Oximetry Plethysmographic Waveform Parameters in High Quality CPR
- ClinicalTrials.gov ID
- NCT03754946
- Acronym / sponsor ID
- 201502019
- Conditions
- Cardiopulmonary Resuscitation
- Keywords
- cardiopulmonary resuscitation, pulse oximetry plethysmographic waveform, quality monitor, partial pressure of end-tidal carbon dioxide
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 27 Nov 2018 (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.
The purpose of this study is to analyze the relationship of the area under the curve (AUC) and/or the amplitude (Amp) of pulse oximetry plethysmographic waveform (POP) with partial pressure of end-tidal carbon dioxide (PETCO2) which could be used to reflect its quality in cardiopulmonary resuscitation (CPR), and then to determine the critical threshold of POP parameters in high quality CPR.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were admitted to the participant hospitals and met the inclusion criteria were included in the study.
Key inclusion criteria (3 listed)
- Cardiac arrested
- The time from cardiac arrest to receiving basic life support is less than 10 minutes
- Get advanced life support (endotracheal intubation and PETCO2 monitoring)
Key exclusion criteria (8 listed)
- Defuse CPR
- chronic obstructive pulmonary disease (COPD) with type II respiratory failure
- Terminal malignant tumors or terminal stage of other diseases
- Rib fracture
- Cardiac arrest caused by hemorrhagic shock pulmonary embolism and cardiac tamponade
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
the cut-off value of POP parameters in High Quality CPR
Time frame: one year
Describe the the cut-off value of POP parameters in High Quality CPR. Receiver operating curve analysis was performed to evaluate the accuracy in predicting return of spontaneous circulation (ROSC).
Compare different predictors
Time frame: one year
Area under curve (AUC) between potential predictors was compared by using a nonparametric test, and the optimal cutoff point was determined by estimating the Youden's index.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2018.
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RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems
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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.
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 Resuscitation, run by Peking Union Medical College 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 8 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 27 Nov 2018. 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 Xuezhong Yu, MD (+86 010 69159142, yxzpumch@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the cut-off value of POP parameters in High Quality CPR (time frame: one year). The study lists 2 primary outcomes in all. 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 27 Nov 2018.