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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03754946
Other study ID # 201502019
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2015
Est. completion date December 31, 2018

Study information

Verified date November 2018
Source Peking Union Medical College Hospital
Contact Xuezhong Yu, MD
Phone +86 010 69159142
Email yxzpumch@126.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 to determine the critical threshold of POP parameters in high quality CPR.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date December 31, 2018
Est. primary completion date June 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- 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)

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Peking Union Medical College Hospital Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). one year
Primary 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. one year
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