Cardiac ArrestNCT06182007
Post-Resuscitation Pneumothorax - Analysis of Incidence, Risk Factors and Outcome Relevance
An observational study of Cardiac Arrest and Pneumothorax, run by Auinger, Daniel MD at 1 site in Austria.
Trial summary
In this retrospective study, the investigators seek to investigate the incidence of pneumothorax following possible risk factors, and elucidate its association with outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest, Pneumothorax, Resuscitation
- What is being tested?
- Cardiopulmonary Resuscitation
- Type of treatment
- Surgery or procedure
- How many people
- 237 participants
- Where
- 1 siteAustria
- Study dates
- 2 Feb 2020to 31 Dec 2022
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Mid-Size European city + surrounding areas
Who may be able to join
- Hospitalized after out of hospital cardiac arrest
- Chest compressions received
- Chest imaging within the first 12 hours of admission
Who cannot join
- Traumatic cardiac arrest
- Chest trauma/surgery/pneumothorax one month prior to cardiac arrest
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pneumothorax After Cardiopulmonary Resuscitation Following Out-of-Hospital Cardiac Arrest - Analysis of Incidence, Risk Factors and Impact on Outcome
In this retrospective study, the investigators seek to investigate the incidence of pneumothorax following possible risk factors, and elucidate its association with outcomes.
Read the detailed description
This is a retrospective analysis of routine data, collected by a single Emergency Medical System (EMS). Adult patients (≥18 years) hospitalised after Out-of-Hospital Cardiac Arrest (OHCA) who received chest compressions and underwent chest imaging within 12 hours after hospital admission were included.
Variables and outcomes ascertained are built up of the core elements of the latest version of the Utstein Resuscitation Registry Template for OHCA. This includes sex, age, aetiology of arrest, response times of the first emergency medical service team and emergency physician, witnessed cardiac arrest, bystander CPR/AED, arrest location, first monitored rhythm, defibrillation time, drugs given, reperfusion attempted and target temperature management. Additional variables studied were pre-existing health status represented by the Pre Emergency Status Assessment (PESA), history of lung disease, no-flow-time (time from collapse until initiation of CPR), use of a mechanical chest compression device and prehospital CPR duration.
The primary outcome is incidence of pneumothorax, secondary outcomes are survival to hospital discharge and favourable neurological condition at hospital discharge defined by a cerebral performance category (CPC) of 1 or 2.
- Conditions
- Cardiac Arrest, Pneumothorax, Resuscitation
- Being tested
- Cardiopulmonary Resuscitation
- Medical subject headings
- Heart Arrest, Pneumothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiopulmonary ResuscitationProcedure or surgery
Cardiopulmonary Resuscitation (Advanced Life Support) according to current guidelines
| Study group | Role | What they receive |
|---|---|---|
| No Pneumothorax | Patients with no pneumothorax reported from the first chest imaging after hospital admission. Receives: Procedure: Cardiopulmonary Resuscitation | |
| Pneumothorax | Patients with a pneumothorax reported from the first chest imaging after hospital admission. Receives: Procedure: Cardiopulmonary Resuscitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of pneumothorax
Measured: within 12 hours of admission
Secondary outcomes (2)
Survival
Measured: to hospital discharge (up to 2 months)
Cerebral Performance Category
Measured: at hospital discharge (up to 2 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start2 Feb 2020
- Primary completion20 Oct 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- Auinger, Daniel MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Auinger, Daniel MD, Medical University of Graz
- Investigators
- Gerhard Prause, Prof., Study director, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06182007
- Sponsor's protocol ID
- PostCPRptx
- Status last verified
- Dec 2023
- First submitted
- 4 Dec 2023
- Last updated
- 26 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Auinger D, Hotzer D, Zajic P, Orlob S, Heschl S, Fida S, Zoidl P, Honnef G, Friedl H, Smolle-Juttner FM, Prause G. Post-resuscitation pneumothorax: retrospective analysis of incidence, risk factors and outcome-relevance. Scand J Trauma Resusc Emerg Med. 2024 Sep 5;32(1):82. doi: 10.1186/s13049-024-01260-8.
PubMed 39238051
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pneumothorax After Cardiopulmonary Resuscitation Following Out-of-Hospital Cardiac Arrest - Analysis of Incidence, Risk Factors and Impact on Outcome
- ClinicalTrials.gov ID
- NCT06182007
- Acronym / sponsor ID
- PostCPRptx
- Conditions
- Cardiac Arrest, Pneumothorax, Resuscitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- Auinger, Daniel MDUniversity, hospital or other
- Study start
- 2 Feb 2020 (actual)
- Primary completion
- 20 Oct 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 26 Dec 2023 (actual)
- 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.
In this retrospective study, the investigators seek to investigate the incidence of pneumothorax following possible risk factors, and elucidate its association with outcomes.
Detailed description
This is a retrospective analysis of routine data, collected by a single Emergency Medical System (EMS). Adult patients (≥18 years) hospitalised after Out-of-Hospital Cardiac Arrest (OHCA) who received chest compressions and underwent chest imaging within 12 hours after hospital admission were included.
Variables and outcomes ascertained are built up of the core elements of the latest version of the Utstein Resuscitation Registry Template for OHCA. This includes sex, age, aetiology of arrest, response times of the first emergency medical service team and emergency physician, witnessed cardiac arrest, bystander CPR/AED, arrest location, first monitored rhythm, defibrillation time, drugs given, reperfusion attempted and target temperature management. Additional variables studied were pre-existing health status represented by the Pre Emergency Status Assessment (PESA), history of lung disease, no-flow-time (time from collapse until initiation of CPR), use of a mechanical chest compression device and prehospital CPR duration.
The primary outcome is incidence of pneumothorax, secondary outcomes are survival to hospital discharge and favourable neurological condition at hospital discharge defined by a cerebral performance category (CPC) of 1 or 2.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Pneumothorax | – | Procedure: Cardiopulmonary ResuscitationPatients with no pneumothorax reported from the first chest imaging after hospital admission. |
| Pneumothorax | – | Procedure: Cardiopulmonary ResuscitationPatients with a pneumothorax reported from the first chest imaging after hospital admission. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Mid-Size European city + surrounding areas
Key inclusion criteria (3 listed)
- Hospitalized after out of hospital cardiac arrest
- Chest compressions received
- Chest imaging within the first 12 hours of admission
Key exclusion criteria (2 listed)
- Traumatic cardiac arrest
- Chest trauma/surgery/pneumothorax one month prior to 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiopulmonary ResuscitationCardiopulmonary Resuscitation (Advanced Life Support) according to current guidelines | Procedure or surgery | No Pneumothorax, Pneumothorax |
Primary outcome
Presence of pneumothorax
Time frame: within 12 hours of admission
2 secondary outcomes
Survival
Time frame: to hospital discharge (up to 2 months)
Cerebral Performance Category
Time frame: at hospital discharge (up to 2 months)
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 26 Dec 2023.
- Derived from this study: PubMed 39238051Auinger D, Hotzer D, Zajic P, Orlob S, Heschl S, Fida S, Zoidl P, Honnef G, Friedl H, Smolle-Juttner FM, Prause G. Post-resuscitation pneumothorax: retrospective analysis of incidence, risk factors and outcome-relevance. Scand J Trauma Resusc Emerg Med. 2024 Sep 5;32(1):82. doi: 10.1186/s13049-024-01260-8.
- 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.
Gerhard Prause, Prof. study director
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest and Pneumothorax, run by Auinger, Daniel MD at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Presence of pneumothorax (time frame: within 12 hours of admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06182007, which also lists 1 linked publication.
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 26 Dec 2023.