NCT03754946

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 27, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

November 27, 2018

Status Verified

November 1, 2018

Enrollment Period

2.8 years

First QC Date

November 15, 2018

Last Update Submit

November 26, 2018

Conditions

Keywords

cardiopulmonary resuscitationpulse oximetry plethysmographic waveformquality monitorpartial pressure of end-tidal carbon dioxide

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who were admitted to the participant hospitals and met the inclusion criteria were included in the study.

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, 100730, China

RECRUITING

Central Study Contacts

Xuezhong Yu, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2018

First Posted

November 27, 2018

Study Start

September 1, 2015

Primary Completion

June 30, 2018

Study Completion

December 31, 2018

Last Updated

November 27, 2018

Record last verified: 2018-11

Locations