Cardiac Arrest With Successful ResuscitationNCT02998749
Gasping Improves Long-term Survival After Out-of-hospital Cardiac Arrest
An observational study of Cardiac Arrest With Successful Resuscitation, run by Charles University, Czech Republic.
Trial summary
The aim of our retrospective clinical study was to examine the association between agonal breathing, return of spontaneous circulation (ROSC), and long-term survival. A secondary aim was to examine role of basic life support (BLS) and response time. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiac Arrest With Successful Resuscitation
- How many people
- 584 participants
- Where
- No sites listed yet
- Study dates
- Jul 2013to Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Victims of primary out-of-hospital cardiac arrest
Inclusion Criteria: all out-of-hospital cardiac arrest cases, of presumed cardiac origin, that where resuscitated by the emergency medical service of Central Bohemia region between 1st July 2013 and 30th June 2014 (n = 584) -
Exclusion Criteria: other than non-cardiac cause of cardiac arrest
-
About this study
Official title: Agonal Breathing is a Positive Predictive Factor of Long Term Survival After Out-of-hospital Cardiac Arrest
The aim of our retrospective clinical study was to examine the association between agonal breathing, return of spontaneous circulation (ROSC), and long-term survival. A secondary aim was to examine role of basic life support (BLS) and response time. Our hypothesis is that agonal breathing has positive effects on both primary and secondary endpoints.
Read the detailed description
Aims Agonal breathing ("gasping for air") has previously been found to be associated with the outcomes of out-of-hospital cardiac arrest (OHCA) patients on which resuscitation was attempted. On the other hand, little is known, about agonal breathing with regard to whether it is a positive factor for survival after hospital admission and how it relates to the patient's future quality of life. For this reason we have undertaken a retrospective study using a comprehensive emergency medical service (EMS) database from the Central Bohemian region of the Czech Republic. The primary endpoint of the study was to assess if agonal breathing present when EMS arrives has a positive impact on the six-month survival of OHCA patients, which was independent of other factors like EMS response time and BLS provision. The secondary endpoints sought to determine if agonal breathing positively impacts ROSC and an evaluation of various factors that can influence agonal breathing, specifically response time and provision of BLS.
Method The data were recorded using the Utstein protocol. Only anonymized data were used for analysis. The data were derived from the EMS registry of the Central Bohemian Region, which is the largest EMS in the Czech Republic. The study sample included all OHCA cases, of presumed cardiac origin, that where resuscitated by the EMS between 1st July 2013 and 30th June 2014 (n = 584). Two subsequent patient outcomes: (1) return of spontaneous circulation (defined as spontaneous circulation at hospital admission) and (2) six-month survival were assessed in patients with and without agonal breathing. Six-month survival data of OHCA patients of presumed cardiac origin was derived from administrative insurance registries or medical records of patients, with only aggregated data being available.
Factors that may influence the presence of agonal breathing, specifically BLS provision before a professional EMS team reached the patient and second, EMS team response times, were also examined. BLS provision by lay persons was reported by the first-on-scene EMS team as (yes/no) and phone assisted CPR was registered by the dispatcher as (yes/no). BLS was considered to have been provided if any of the following activities (1) resuscitation by a bystander, (2) phone assisted CPR, or (3) both were recorded as having been performed. The response time was calculated as the elapsed time between recorded activation of an EMS team and the on scene arrival time.
Other covariates such as age and sex were also available and analyzed. The initial difference in response time between the groups was assessed using the T-test. For categorical variables, the chi-square test was used. Simple and multivariate logistic regression models were used to assess relationships between factors related to the presence of agonal breathing and ROSC. A p-value of < 0.05 was considered statistically significant.
What is being measured
The primary outcome is the main question the study is designed to answer.
association between agonal breathing and long-term survival
Measured: 6 months after successful resuscitation
Secondary outcomes (1)
impact of agonal breathing on return of spontaneous circulation
Measured: immediately after resuscitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study startJul 2013
- Primary completionJun 2014
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Arrest With Successful ResuscitationStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 584 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiri Malek, Charles University, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02998749
- Sponsor's protocol ID
- Gasping1
- Status last verified
- Dec 2016
- First submitted
- 16 Dec 2016
- Last updated
- 20 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Agonal Breathing is a Positive Predictive Factor of Long Term Survival After Out-of-hospital Cardiac Arrest
- ClinicalTrials.gov ID
- NCT02998749
- Acronym / sponsor ID
- Gasping1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 584 participants (actual)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 20 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of our retrospective clinical study was to examine the association between agonal breathing, return of spontaneous circulation (ROSC), and long-term survival. A secondary aim was to examine role of basic life support (BLS) and response time. Our hypothesis is that agonal breathing has positive effects on both primary and secondary endpoints.
Detailed description
Aims Agonal breathing ("gasping for air") has previously been found to be associated with the outcomes of out-of-hospital cardiac arrest (OHCA) patients on which resuscitation was attempted. On the other hand, little is known, about agonal breathing with regard to whether it is a positive factor for survival after hospital admission and how it relates to the patient's future quality of life. For this reason we have undertaken a retrospective study using a comprehensive emergency medical service (EMS) database from the Central Bohemian region of the Czech Republic. The primary endpoint of the study was to assess if agonal breathing present when EMS arrives has a positive impact on the six-month survival of OHCA patients, which was independent of other factors like EMS response time and BLS provision. The secondary endpoints sought to determine if agonal breathing positively impacts ROSC and an evaluation of various factors that can influence agonal breathing, specifically response time and provision of BLS.
Method The data were recorded using the Utstein protocol. Only anonymized data were used for analysis. The data were derived from the EMS registry of the Central Bohemian Region, which is the largest EMS in the Czech Republic. The study sample included all OHCA cases, of presumed cardiac origin, that where resuscitated by the EMS between 1st July 2013 and 30th June 2014 (n = 584). Two subsequent patient outcomes: (1) return of spontaneous circulation (defined as spontaneous circulation at hospital admission) and (2) six-month survival were assessed in patients with and without agonal breathing. Six-month survival data of OHCA patients of presumed cardiac origin was derived from administrative insurance registries or medical records of patients, with only aggregated data being available.
Factors that may influence the presence of agonal breathing, specifically BLS provision before a professional EMS team reached the patient and second, EMS team response times, were also examined. BLS provision by lay persons was reported by the first-on-scene EMS team as (yes/no) and phone assisted CPR was registered by the dispatcher as (yes/no). BLS was considered to have been provided if any of the following activities (1) resuscitation by a bystander, (2) phone assisted CPR, or (3) both were recorded as having been performed. The response time was calculated as the elapsed time between recorded activation of an EMS team and the on scene arrival time.
Other covariates such as age and sex were also available and analyzed. The initial difference in response time between the groups was assessed using the T-test. For categorical variables, the chi-square test was used. Simple and multivariate logistic regression models were used to assess relationships between factors related to the presence of agonal breathing and ROSC. A p-value of < 0.05 was considered statistically significant.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Victims of primary out-of-hospital cardiac arrest
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
association between agonal breathing and long-term survival
Time frame: 6 months after successful resuscitation
1 secondary outcome
impact of agonal breathing on return of spontaneous circulation
Time frame: immediately after resuscitation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest With Successful Resuscitation, run by Charles University, Czech Republic.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
association between agonal breathing and long-term survival (time frame: 6 months after successful resuscitation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2016.