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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03062306
Other study ID # 2016/351
Secondary ID Erciyes Universi
Status Completed
Phase
First received
Last updated
Start date May 31, 2017
Est. completion date August 31, 2018

Study information

Verified date February 2019
Source Nevsehir Public Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


Description:

The Near-Infrared Spectroscopy (NIRS), which is used in measuring the cerebral tissue oxygenation is one of the latest technologies that allow the measurement of brain oxygen saturation. With this study, the issue of whether sufficient cerebral oxygenation is provided during CPR applied to patients that have Cardiac Arrest (CA) will be investigated, and the effect of CPR on the patient prognosis after ROSC will be examined. In this study, the aim is to investigate whether sufficient oxygenation is provided in synchronization with chest compressions during CPR; and to test the regional brain tissue saturation with rSO2 measurement, and the prognosis with Full Outline of UnResponsiveness (FOUR) Score in patients with ROSC.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date August 31, 2018
Est. primary completion date August 31, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. All patients undergoing cardiac arrest in intensive care unit

Exclusion Criteria:

1. Head injury and intracranial bleeding

2. Cerebral ischemic vascular event

3. Pulmonary diseases that may affect blood-oxygen levels

4. Below the age of 18

Study Design


Related Conditions & MeSH terms

  • Providing Sufficient Cerebral Oxygenation During CPR

Locations

Country Name City State
Turkey Mehmet Akif YAZAR Nevsehir

Sponsors (1)

Lead Sponsor Collaborator
Nevsehir Public Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Kämäräinen 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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Change from baseline in consciousness on Full Outline of UnResponsiveness (FOUR) Score at one week The patient's consciousness will be evaluated by FOUR score in patients with ROSC For a week after ROSC