Quality of the Cardio-pulmonary Resuscitation

• Sponsor: Tampere University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05250453
• Collaborator: National Istitute For Health and Welfare, Finland (Other)
• Enrollment: 400
• Location: 1
• Anticipated Duration (Months): 17.9
• Patients Per Site Per Month: 22.3

Study Details

Study Description

Brief Summary

Patients having sudden cardiac arrest have very poor prognosis. It is devastating for patient and family. But also very expensive for nations economics when working-age people die or disable due to cardiac arrest. Recent studies have shown that high quality of cardiopulmonary resuscitation (CPR) and minimized delays increases the survival after cardiac arrest. In this objective prospective study we will use Zoll´s X Series defibrillator on every emergency medicine systems (EMS´s) unit in Pirkanmaa area, Finland, to collect information on CPR quality. Real CPR Help® will collect the information on depth, frequency and pauses during CPR. We will make an Utstein analysis on OHCA during one year period and compare the results on Utstein analysis made in the same area on 2013-2014. We will analyse the quality of CPR and compare it to the outcome from OHCA and neurological outcome 3 months after resuscitation. In addition we will analyse the CPR related injuries and compare these to the compression depth and number of persons performing CPR.

In one part of the study we will evaluate the incidence of OHCA in different risk areas of Pirkanmaa and analyse the influence of time delay and location to the outcome out of hospital and neurological outcome 3 months after resuscitation. We will also analyse if the time of post-resuscitation care before getting to the hospital or stenosis in carotid artery affects the outcome from OHCA and neurological outcome 3 months after resuscitation.

Condition or Disease	Intervention/Treatment	Phase
Cardiopulmonary Resuscitation

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 400 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Cardiopulmonary Resuscitation; Epidemiology, Quality, Survival and Injuries.
• Actual Study Start Date: Jan 1, 2022
• Anticipated Primary Completion Date: Mar 31, 2023
• Anticipated Study Completion Date: Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Cardiac arrest All patients having sudden cardiac arrest out-of-hospital in Pirkanmaa, Finland
ResusInj OHCA survivors having CPR related injuries or carotid stenosis analyzed by CT
ResusCPC OHCA survivors neurological outcome

Outcome Measures

Primary Outcome Measures

1. QualityCPR [1 year]

   The success rate of current guidelines (depth and frequency of chest compression, epidemiology)

2. Neurological survival after CA [3 months after OHCA]

   Neurological survival after CA

Secondary Outcome Measures

1. CPR related injuries [1 year]

   Injuries detected in CT scanning or in autopsy

2. Stenosis of the carotid artery [3 months after OHCA]

   Effect of the carotid artery stenosis to the neurological survival. Survivals having CPC 1-2 prior to the cardiac arrest and are taken to the ICU are scanned with carotid CTA after informed consent. The degree of stenosis will be compared to the CPC-level 3monts aften OHCA.

3. the dispatch calls concerning OHCA [1 year]

   Analyze the key words and dispatch assisted CPR through the emergency call. All emergency call conserning OHCA patients will be listened. We will analyze the keywords which are used by layperson to describe patient having cardiac arrest. We will also analyze the amount of given dispatch assisted CPR and compare the amount to the primary rythm.

4. the quality of the postresuscitation care [3 months after OHCA]

   The correlation of the duration and the quality of the postresuscitation care before getting in to the hospital and the outcome from OHCA

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• cardiac arrest

• 18 years of age

Exclusion Criteria:

• < 18 years of age

• prisoners

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tampere University hospital	Tampere		Finland	33521

Sponsors and Collaborators

• Tampere University Hospital
• National Istitute For Health and Welfare, Finland

Investigators

• Study Director: Piritta Setälä, PhD, Tampere University Hospital
• Study Director: Sanna Hoppu, PhD, Tampere University Hospital
• Principal Investigator: Jyrki Ollikainen, MD, Tampere University Hospital
• Study Director: Kati Järvelä, PhD, Tampere University Hospital
• Principal Investigator: Valtteri Järvenpää, MB, Tampere University Hospital
• Study Director: Ville Jalkanen, PhD, Tampere University Hospital
• Study Director: Joonas Tirkkonen, PhD, Tampere University Hospital
• Study Director: Heini Huhtala, PhD, Tampere University
• Study Director: Mika Martiskainen, PhD, Finnish Institute for Health and Welfare
• Study Director: Riikka Nevalainen, MD, Tampere University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tampere University Hospital
• ClinicalTrials.gov Identifier: NCT05250453
• Other Study ID Numbers: R18100; R18163; R21124
• First Posted: Feb 22, 2022
• Last Update Posted: Feb 22, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Tampere University Hospital: CPR, injuries, OHCA

Study Results

No Results Posted as of Feb 22, 2022