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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02585050
Other study ID # ADYU 2
Secondary ID
Status Completed
Phase N/A
First received October 21, 2015
Last updated October 22, 2015
Start date January 2010
Est. completion date January 2015

Study information

Verified date October 2015
Source Adiyaman University Research Hospital
Contact n/a
Is FDA regulated No
Health authority Turkey: Ministry of Health
Study type Observational

Clinical Trial Summary

Debates about the official and legal implementation of Do not attempt resuscitation (DNAR) orders are ongoing. The aim of this study was to determinate factors that influence neurological outcomes at discharge and the ratio of living patients discharged from the hospital due to DNAR prohibition.


Description:

Study Design and Setting:

This is a single-center, retrospective chart review performed in a 180-bed rural city hospital.

Methods of Measurements:

Study was conducted as retrospective chart review of CPR call forms that were completed between February 2010 and February 2012. Approximately 450,000 patients were annually admitted to this hospital; 1800 patients were hospitalized in wards, and 500 patients were hospitalized in intensive care units during the study period. A form termed the CPR call form is completed by the leader of the CPR team at the end of all calls. These forms are filed in the hospital archive in chronological order. The hospital uses the resuscitation guidelines from the American Heart Association, and all healthcare providers of the CPR team are certified in basic cardiac life support (BCLS) and advanced cardiovascular life support (ACLS).

Study Population The data were collected from the CPR call forms and hospital medical records. All data were noted by using the Utstein-style reporting template and included the demographic data (date of birth/age and gender), date of arrest, time of first CPR attempt, etiology, preexisting conditions, location of arrest, arrest witnessed (a witnessed cardiac arrest is one that is observed or heard by another person or an arrest that is monitored), initial rhythm, duration of CPR attempt, end of event, date of discharge or death and neurological outcomes at discharge from the hospital.

CPR attempts were defined as an attempt to restore spontaneous circulation by performing chest compressions with or without ventilation. ROSC was defined by a status in which spontaneous circulation was sustained for at least 20 minutes.

Neurological outcomes at discharge were determined with a Cerebral Performance Category (CPC) score based on the last neurological examination of the patients before discharge. CPC scores of 1 or 2 were considered good neurological outcomes, and CPC scores of 3, 4 and 5 were considered poor neurological outcomes.

Data Analysis The continuous variables are expressed as the means and SD. The categorical data are expressed as percentages. Chi-square tests were used for the univariate analyses of categorical variables. Statistical significance was defined as p<0.05. The data were analyzed with SPSS v. 17.0.


Recruitment information / eligibility

Status Completed
Enrollment 266
Est. completion date January 2015
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 19 Years to 100 Years
Eligibility Inclusion Criteria:

1. Patients experienced inhospital CPR attempts due to cardiac arrest

2. Patients who did not have DNAR orders

Exclusion Criteria:

1. Patients below 18 years of age

2. Calls performed due to code blue drills

3. Missing calls

4. Patients with more than one cardiac arrest

5. Patients with CPR attempts that began outside the hospital who were admitted to the emergency department.

6. Patients with missing the data in hospital medical records.

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Adiyaman University Research Hospital Adiyaman Central

Sponsors (1)

Lead Sponsor Collaborator
Adiyaman University Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Field RA, Fritz Z, Baker A, Grove A, Perkins GD. Systematic review of interventions to improve appropriate use and outcomes associated with do-not-attempt-cardiopulmonary-resuscitation decisions. Resuscitation. 2014 Nov;85(11):1418-31. doi: 10.1016/j.resu — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Examine survival rate from data obtained by retrospective chart review of patients who have not DNAR order and performed CPR due to cardiac arrest in the period 2010-2012 Data obtained by retrospective chart review will data including etiology, preexisting conditions, initial rhythm, end of event (any return of spontaneous circulation or not) live or death at discharged from hospital. Two years No
Secondary Examine the influence on neurological outcomes at discharge of DNAR order prohibition from data obtained by retrospective chart review. Data obtained by retrospective chart review will data including neurological outcomes at discharge from the hospital. two years No
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