NCT03062306

Brief Summary

In recent years, monitorizations during Cardiopulmonary Resuscitation (CPR) are inadequate to show the sufficiency of cerebral oxygenation. During CPR, insufficient chest compressions have critical importance for neurological results and life quality after the return of spontaneous circulation (ROSC).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

May 31, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
Last Updated

February 22, 2019

Status Verified

February 1, 2019

Enrollment Period

3 months

First QC Date

February 16, 2017

Last Update Submit

February 20, 2019

Conditions

Providing Sufficient Cerebral Oxygenation During CPR

Keywords

Cerebral OxygenationCardiopulmonary ResuscitationChest Compression

Outcome Measures

Primary Outcomes (1)

  • The levels of regional brain tissue oxygen saturation (rSO2) providing with chest compressions during Cardiopulmonary Resuscitation (CPR)

    The data will be obtained by using the Near Infrared Spectroscopy (NIRS) Device and will be recorded rSO2 measurement during the resuscitation of the Cardiac Arrest (CA) patients

    About six month

Secondary Outcomes (1)

  • Change from baseline in consciousness on Full Outline of UnResponsiveness (FOUR) Score at one week

    For a week after ROSC

Eligibility Criteria

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

All patients undergoing cardiac arrest in intensive care unit

You may qualify if:

  • \. All patients undergoing cardiac arrest in intensive care unit

You may not qualify if:

  • Head injury and intracranial bleeding
  • Cerebral ischemic vascular event
  • Pulmonary diseases that may affect blood-oxygen levels
  • Below the age of 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mehmet Akif YAZAR

Nevşehir, 50100, Turkey (Türkiye)

Location

Related Publications (2)

  • Parnia S, Nasir A, Shah C, Patel R, Mani A, Richman P. A feasibility study evaluating the role of cerebral oximetry in predicting return of spontaneous circulation in cardiac arrest. Resuscitation. 2012 Aug;83(8):982-5. doi: 10.1016/j.resuscitation.2012.01.039. Epub 2012 Feb 6.

    PMID: 22322284BACKGROUND

  • Kamarainen A, Sainio M, Olkkola KT, Huhtala H, Tenhunen J, Hoppu S. Quality controlled manual chest compressions and cerebral oxygenation during in-hospital cardiac arrest. Resuscitation. 2012 Jan;83(1):138-42. doi: 10.1016/j.resuscitation.2011.09.011. Epub 2011 Sep 28.

    PMID: 21958930BACKGROUND

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Critical Care Physician

Study Record Dates

First Submitted

February 16, 2017

First Posted

February 23, 2017

Study Start

May 31, 2017

Primary Completion

August 31, 2017

Study Completion

August 31, 2018

Last Updated

February 22, 2019

Record last verified: 2019-02

Locations

TU(1)