Cardiac ArrestTeleMaccNCT01936597
Prospective Study of 3 Phone Assistance Strategies to Achieve a Continuous Cardiac Massage
A study testing Therapeutic and preventive strategies in people with Cardiac Arrest, run by University Hospital, Rouen at 1 site in France.
Trial summary
This study must evaluate the benefit of a continuous audio guidance on the effectiveness of MCE directed by a volunteer. The evaluation of the MCE for this study is based on both quantitative criteria (based on the recommendations ERC 2010) frequency depth of chest compressions. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- Therapeutic and preventive strategies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2013to Nov 2013
- Phase
- Interventional
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers from the general population understanding the French language.
Who cannot join
- major physical disability;
- do not speak French
- first aid training under one year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study of 3 Phone Assistance Strategies to Achieve a Continuous Cardiac Massage During Training in Non-hospital Cardiac Cases.
This study must evaluate the benefit of a continuous audio guidance on the effectiveness of MCE directed by a volunteer.
The evaluation of the MCE for this study is based on both quantitative criteria (based on the recommendations ERC 2010)
- frequency
- depth of chest compressions.
This study compares two methods of continuous audio guide (one arm with an audio continuous guidance method by the regulator and second arm with an audio continuous guidance method by the controller relayed by an audio) to a method of incentive MCE based on a unique set made by the regulator(control arm).
- Conditions
- Cardiac Arrest
- Being tested
- Therapeutic and preventive strategies
- Keywords
- external cardiac massage, medical hotline,
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic and preventive strategiesOther
Single set (control Arm)
Therapeutic and preventive strategiesOther
Controller
Therapeutic and preventive strategiesOther
Audio
| Study group | Role | What they receive |
|---|---|---|
| Single set (control Arm) | Active comparator | method of external cardiac massage incentive based on a single set. Intervention : Therapeutic and preventive strategies Receives: Other: Therapeutic and preventive strategies |
| Controller | Experimental | Audio continuous guidance method by the controller. Intervention : Therapeutic and preventive strategies Receives: Other: Therapeutic and preventive strategies |
| Audio | Experimental | Audio continuous guidance method by the controller relayed by an audio. Intervention : Therapeutic and preventive strategies Receives: Other: Therapeutic and preventive strategies |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency and depth of chest compressions
Measured: at the end of the simulation (10 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionSep 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cédric DAMM, Doctor, Principal investigator, CHU - Hôpitaux de Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01936597
- Sponsor's protocol ID
- 2012/182/HP
- Other IDs
- 2012-A01257-36
- Acronym
- TeleMacc
- Status last verified
- Jun 2014
- First submitted
- 2 Sep 2013
- Last updated
- 19 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of 3 Phone Assistance Strategies to Achieve a Continuous Cardiac Massage During Training in Non-hospital Cardiac Cases.
- ClinicalTrials.gov ID
- NCT01936597
- Acronym / sponsor ID
- TeleMacc / 2012/182/HP
- Conditions
- Cardiac Arrest
- Keywords
- external cardiac massage, medical hotline,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 6 Sep 2013 (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.
This study must evaluate the benefit of a continuous audio guidance on the effectiveness of MCE directed by a volunteer.
The evaluation of the MCE for this study is based on both quantitative criteria (based on the recommendations ERC 2010)
- frequency
- depth of chest compressions.
This study compares two methods of continuous audio guide (one arm with an audio continuous guidance method by the regulator and second arm with an audio continuous guidance method by the controller relayed by an audio) to a method of incentive MCE based on a unique set made by the regulator(control arm).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single set (control Arm) | Active comparator | Other: Therapeutic and preventive strategiesmethod of external cardiac massage incentive based on a single set. Intervention : Therapeutic and preventive strategies |
| Controller | Experimental | Other: Therapeutic and preventive strategiesAudio continuous guidance method by the controller. Intervention : Therapeutic and preventive strategies |
| Audio | Experimental | Other: Therapeutic and preventive strategiesAudio continuous guidance method by the controller relayed by an audio. Intervention : Therapeutic and preventive strategies |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy volunteers from the general population understanding the French language.
Key exclusion criteria (3 listed)
- major physical disability;
- do not speak French
- first aid training under one year
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 |
|---|---|---|
| Therapeutic and preventive strategiesSingle set (control Arm) | Other | Single set (control Arm) |
| Therapeutic and preventive strategiesController | Other | Controller |
| Therapeutic and preventive strategiesAudio | Other | Audio |
Primary outcome
frequency and depth of chest compressions
Time frame: at the end of the simulation (10 minutes)
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 19 Jun 2014.
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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.
Cédric DAMM, Doctor principal investigator
CHU - Hôpitaux de Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic and preventive strategies in people with Cardiac Arrest, run by University Hospital, Rouen at 1 site in France.
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 1 inclusion and 3 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 19 Jun 2014. 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 France. 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?
frequency and depth of chest compressions (time frame: at the end of the simulation (10 minutes)). 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 19 Jun 2014.