Cardiopulmonary ArrestNCT02045498
Effect of Capnography Feedback During Cardiopulmonary Resuscitation (CPR ) on Patient's Outcome
A study testing capnography feedback in people with Cardiopulmonary Arrest, run by Mashhad University of Medical Sciences at 1 site in Iran.
Trial summary
Compare the quality performance of rescuers and resuscitation outcomes of cardiac arrest patients in both groups with and without capnography feedback Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiopulmonary Arrest
- What is being tested?
- capnography feedback
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteIran
- Study dates
- Feb 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- cardiac arrest patient age more than 18
Who cannot join
- age more than 80 cardiac arrest due to pulmonary embolism
Trial locations and contacts
1 site in 1 country.
Iran1 site
Ghaem Educational, Research and Treatment Center
Mashhad, Razavi Khorasan Province, (+98 511) 8023024-6
About this study
Official title: Effect of Capnography Feedback During Cardiopulmonary Resuscitation on Quality Performance of Rescuers and Outcome of the Patient
Compare the quality performance of rescuers and resuscitation outcomes of cardiac arrest patients in both groups with and without capnography feedback
Read the detailed description
This study has done at Mashhad Ghaem Educational center. Two nurses and an anesthesia resident selected and trained according to the latest guidelines of CPR . In the control sample, with the declare of code 99 and attend the team on the patient's bedside, CPR begins and then every two minutes, return of the patient checks in the usual way. quality performance of rescuers ,Recovery or death of the patient and the result is recording. In the second phase , group members were educated how to use capnography (Comdek's MD-660P Oxi-Capnography) in CPR and guiding restoration efforts by it. with the code 99 and attend the team on the patient's bedside capnography uses and its waveforms will appear on the monitor device which is visible to all rescuers and the quality of performance is renewed based on the its guidance. The two groups patients for age, sex, initial rhythm of arrest, time of arrest until the first action, the time of arrest until the first shocks are comparing to control these factors influence on the outcome. quality performance of rescuers , resuscitation outcomes and CPR duration and relative factors in each of the groups were recorded and compared.
- Conditions
- Cardiopulmonary Arrest
- Being tested
- capnography feedback
- Keywords
- cpr, feedback, capnography, outcome, quality, resuscitation
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capnography feedbackDevice
capnography feedback was used for management of the resuscitation and quality of cpr performance in rescuers and outcomes of the patients was measured.
| Study group | Role | What they receive |
|---|---|---|
| capnography, feedback, quality of cpr | Experimental | capnography feedback was used for management of the resuscitation and quality of cpr performance in rescuers and outcomes of the patients was measured. Receives: Device: capnography feedback |
| conventional cpr | No intervention | conventional cpr |
What is being measured
The primary outcome is the main question the study is designed to answer.
chest compressions and artificial ventilation rate in a minute
The number Of chest compressions and artificial ventilation rate in a minute by rescuers in both study groups (with and without capnography feedback) were assessed.
Measured: By the end of twenty minutes of CPR
Secondary outcomes (1)
Return of spontaneous circulation or death of patient at the end of resuscitation
Return of spontaneous circulation or death of patient at the end of resuscitation in both study groups (with and without capnography feedback) were assessed.
Measured: about twenty minutes After start of CPR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2014 (estimated)
- Study startFeb 2013
- Primary completionOct 2013
- Study completionNov 2013
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 Cardiopulmonary 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seyedreza Mazloum, Mashhad University of Medical Sciences
- Investigators
- Tayebe PourGhaznein, MSc, Study director, MUMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02045498
- Sponsor's protocol ID
- capnography feedback
- Status last verified
- Jan 2014
- First submitted
- 19 Jan 2014
- Last updated
- 27 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Qvigstad E, Kramer-Johansen J, Tomte O, Skalhegg T, Sorensen O, Sunde K, Olasveengen TM. Clinical pilot study of different hand positions during manual chest compressions monitored with capnography. Resuscitation. 2013 Sep;84(9):1203-7. doi: 10.1016/j.resuscitation.2013.03.010. Epub 2013 Mar 15.
PubMed 23499897
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Capnography Feedback During Cardiopulmonary Resuscitation on Quality Performance of Rescuers and Outcome of the Patient
- ClinicalTrials.gov ID
- NCT02045498
- Acronym / sponsor ID
- capnography feedback
- Conditions
- Cardiopulmonary Arrest
- Keywords
- cpr, feedback, capnography, outcome, quality, resuscitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 27 Jan 2014 (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.
Compare the quality performance of rescuers and resuscitation outcomes of cardiac arrest patients in both groups with and without capnography feedback
Detailed description
This study has done at Mashhad Ghaem Educational center. Two nurses and an anesthesia resident selected and trained according to the latest guidelines of CPR . In the control sample, with the declare of code 99 and attend the team on the patient's bedside, CPR begins and then every two minutes, return of the patient checks in the usual way. quality performance of rescuers ,Recovery or death of the patient and the result is recording. In the second phase , group members were educated how to use capnography (Comdek's MD-660P Oxi-Capnography) in CPR and guiding restoration efforts by it. with the code 99 and attend the team on the patient's bedside capnography uses and its waveforms will appear on the monitor device which is visible to all rescuers and the quality of performance is renewed based on the its guidance. The two groups patients for age, sex, initial rhythm of arrest, time of arrest until the first action, the time of arrest until the first shocks are comparing to control these factors influence on the outcome. quality performance of rescuers , resuscitation outcomes and CPR duration and relative factors in each of the groups were recorded and compared.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| capnography, feedback, quality of cpr | Experimental | Device: capnography feedbackcapnography feedback was used for management of the resuscitation and quality of cpr performance in rescuers and outcomes of the patients was measured. |
| conventional cpr | No intervention | –conventional cpr |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- cardiac arrest patient age more than 18
Key exclusion criteria (1 listed)
- age more than 80 cardiac arrest due to pulmonary embolism
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 |
|---|---|---|
| capnography feedbackcapnography feedback was used for management of the resuscitation and quality of cpr performance in rescuers and outcomes of the patients was measured. | Device | capnography, feedback, quality of cpr |
Primary outcome
chest compressions and artificial ventilation rate in a minute
Time frame: By the end of twenty minutes of CPR
The number Of chest compressions and artificial ventilation rate in a minute by rescuers in both study groups (with and without capnography feedback) were assessed.
1 secondary outcome
Return of spontaneous circulation or death of patient at the end of resuscitation
Time frame: about twenty minutes After start of CPR
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 27 Jan 2014.
- Background: PubMed 23499897Qvigstad E, Kramer-Johansen J, Tomte O, Skalhegg T, Sorensen O, Sunde K, Olasveengen TM. Clinical pilot study of different hand positions during manual chest compressions monitored with capnography. Resuscitation. 2013 Sep;84(9):1203-7. doi: 10.1016/j.resuscitation.2013.03.010. Epub 2013 Mar 15.
- In-hospital Cardiac Arrest: Catching up with Advances Made in Out-Of-Hospital Cardiac ArrestLink provided by the sponsor.
Related trials for Cardiopulmonary Arrest
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Execution of Prehospital Transesophageal Echocardiography During Cardiopulmonary Resuscitation in Patients With Out-of-hospital Cardiac Arrest
Out-of-hospital Cardiac Arrest (OHCA)
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The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients Suffering an Out-of-hospital Cardiac Arrest
Cardiac Arrest, Out-Of-Hospital
Active, not recruiting
RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems
Cardiac Arrest
RecruitingObservational study
Cardiac Arrest - Ultrasound Detection of Occult Perfusion
Cardiac Arrest, Out-Of-Hospital, Hypotension
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.
Tayebe PourGhaznein, MSc study director
MUMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing capnography feedback in people with Cardiopulmonary Arrest, run by Mashhad University of Medical Sciences at 1 site in Iran.
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 1 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 27 Jan 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 Iran. 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?
chest compressions and artificial ventilation rate in a minute (time frame: By the end of twenty minutes of CPR). 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 NCT02045498, 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 27 Jan 2014.