ArrhythmiaPhase 3NCT00000502
Evaluation of SC-V Versus Conventional CPR
A Phase 3 study testing cardiopulmonary resuscitation in people with Arrhythmia and Cardiovascular Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To assess the benefits of a new method of cardiopulmonary resuscitation, SC-V CPR (simultaneous compression and ventilation CPR) in terms of short and long-term survival and lessened cerebral dysfunction. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Arrhythmia, Cardiovascular Diseases, Heart Arrest
- What is being tested?
- cardiopulmonary resuscitation
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 1981to Jun 1985
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Men, women, and children in cardiac arrest for which CPR was initiated in ten minutes or less from the time of arrest.
About this study
To assess the benefits of a new method of cardiopulmonary resuscitation, SC-V CPR (simultaneous compression and ventilation CPR) in terms of short and long-term survival and lessened cerebral dysfunction.
Read the detailed description
BACKGROUND:
Since the 1960's, developments in cardiopulmonary resuscitation have resulted in the savings of countless numbers of lives. More recently, the emphasis has been on increasing CPR capability through the development of prehospital emergency care systems and the involvement of the lay public in the provision of CPR. The effectiveness of this technique in the prehospital setting has been demonstrated in several community studies of patients in cardiac arrest where survival rates ranged from 11-17 percent.
Additionally, for patients in ventricular fibrillation, the proportion of patients discharged alive ranged from 14-30 percent in five cities where the outcome of EMS programs has been examined. These successes, however, concealed many failures in which CPR could not reverse death even though correctly applied within established periods between arrest and resuscitation. However, considerable potential existed for improving CPR techniques and for making additional inroads towards the estimated 100,000 deaths each year in the United States that could be reversed through the widespread application of CPR.
A major goal of CPR is to maintain adequate peripheral perfusion (particularly the cerebral and coronary circulation) during cardiac arrest while attempts are being made to restore normal cardiac function. Maneuvers which increase intrathoracic pressure, such as total airway occlusion during chest compression and abdominal compression by binding, have been shown to increase carotid blood flow in the dog.
Sixteen periods of conventional CPR followed by SC-V CPR and return to conventional CPR were studied in 11 cases of in-hospital cardiac arrest at Johns Hopkins University. The findings indicated that simultaneous compression and ventilation at high airway pressures (SC-V CPR) greatly increased carotid flow velocity and radial artery pressure over values achieved with conventional CPR. Maximum benefit was achieved in patients in whom standard or conventional cardiopulmonary resuscitation was least effective. The increases in flow index noted with simultaneous compression and ventilation were up to 274 percent of control.
The success of this new method of CPR had been demonstrated during in-hospital clinical trials. The benefits of this method suggested the need to test the technique in the prehospital setting where the vast majority of cardiac arrests occur.
DESIGN NARRATIVE:
Units of the Miami and Dade County Rescue Squads utilized the technique in a mid-point cross-over design. One of the three shifts at each of the study rescue stations had been thoroughly instructed in the SC-V CPR protocol. A second crew was given an intensive review of conventional CPR methodology. The third shift initially received the conventional CPR review and continued to perform conventional CPR. After six months, the third shift was trained in SC-V CPR and utilized the technique for one year. At the cross-over point, the crew trained in SC-V CPR received the same intensive review of conventional CPR as did the other crew. The conventional CPR crews, in turn, were trained in SC-V CPR. Total sample size was 994 patients, 494 in the treatment group and 500 in the control group.
The study completion date listed in this record was obtained from the Query/View/Report (QVR) System.
- Conditions
- Arrhythmia, Cardiovascular Diseases, Heart Arrest, Heart Diseases, Myocardial Infarction, Ventricular Fibrillation
- Being tested
- cardiopulmonary resuscitation
- Medical subject headings
- Arrhythmias, Cardiac, Cardiovascular Diseases, Heart Arrest, Heart Diseases, Myocardial Infarction, Ventricular Fibrillation, Hypoxia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiopulmonary resuscitationProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 1999 (estimated)
- Study startSep 1981
- Study completionJun 1985
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 ArrhythmiaStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The 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 3
- Primary purpose
- Treatment
- Intervention model
- Crossover
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000502
- Sponsor's protocol ID
- 21
- Other IDs
- R01HL028941-03
- Status last verified
- May 2000
- First submitted
- 27 Oct 1999
- Last updated
- 26 Nov 2013
- Results posted
- No
Publications
Krischer JP, Fine EG, Weisfeldt ML, Guerci AD, Nagel E, Chandra N. Comparison of prehospital conventional and simultaneous compression-ventilation cardiopulmonary resuscitation. Crit Care Med. 1989 Dec;17(12):1263-9. doi: 10.1097/00003246-198912000-00005.
PubMed 2591221
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of SC-V Versus Conventional CPR
- ClinicalTrials.gov ID
- NCT00000502
- Acronym / sponsor ID
- 21
- Conditions
- Arrhythmia, Cardiovascular Diseases, Heart Arrest, Heart Diseases, Myocardial Infarction, Ventricular Fibrillation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 1981
- Study completion
- Jun 1985 (actual)
- First posted
- 28 Oct 1999 (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.
To assess the benefits of a new method of cardiopulmonary resuscitation, SC-V CPR (simultaneous compression and ventilation CPR) in terms of short and long-term survival and lessened cerebral dysfunction.
Detailed description
BACKGROUND:
Since the 1960's, developments in cardiopulmonary resuscitation have resulted in the savings of countless numbers of lives. More recently, the emphasis has been on increasing CPR capability through the development of prehospital emergency care systems and the involvement of the lay public in the provision of CPR. The effectiveness of this technique in the prehospital setting has been demonstrated in several community studies of patients in cardiac arrest where survival rates ranged from 11-17 percent.
Additionally, for patients in ventricular fibrillation, the proportion of patients discharged alive ranged from 14-30 percent in five cities where the outcome of EMS programs has been examined. These successes, however, concealed many failures in which CPR could not reverse death even though correctly applied within established periods between arrest and resuscitation. However, considerable potential existed for improving CPR techniques and for making additional inroads towards the estimated 100,000 deaths each year in the United States that could be reversed through the widespread application of CPR.
A major goal of CPR is to maintain adequate peripheral perfusion (particularly the cerebral and coronary circulation) during cardiac arrest while attempts are being made to restore normal cardiac function. Maneuvers which increase intrathoracic pressure, such as total airway occlusion during chest compression and abdominal compression by binding, have been shown to increase carotid blood flow in the dog.
Sixteen periods of conventional CPR followed by SC-V CPR and return to conventional CPR were studied in 11 cases of in-hospital cardiac arrest at Johns Hopkins University. The findings indicated that simultaneous compression and ventilation at high airway pressures (SC-V CPR) greatly increased carotid flow velocity and radial artery pressure over values achieved with conventional CPR. Maximum benefit was achieved in patients in whom standard or conventional cardiopulmonary resuscitation was least effective. The increases in flow index noted with simultaneous compression and ventilation were up to 274 percent of control.
The success of this new method of CPR had been demonstrated during in-hospital clinical trials. The benefits of this method suggested the need to test the technique in the prehospital setting where the vast majority of cardiac arrests occur.
DESIGN NARRATIVE:
Units of the Miami and Dade County Rescue Squads utilized the technique in a mid-point cross-over design. One of the three shifts at each of the study rescue stations had been thoroughly instructed in the SC-V CPR protocol. A second crew was given an intensive review of conventional CPR methodology. The third shift initially received the conventional CPR review and continued to perform conventional CPR. After six months, the third shift was trained in SC-V CPR and utilized the technique for one year. At the cross-over point, the crew trained in SC-V CPR received the same intensive review of conventional CPR as did the other crew. The conventional CPR crews, in turn, were trained in SC-V CPR. Total sample size was 994 patients, 494 in the treatment group and 500 in the control group.
The study completion date listed in this record was obtained from the Query/View/Report (QVR) System.
Study design
- Primary purpose
- Treatment
- Intervention model
- Crossover
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 resuscitation | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 Nov 2013.
- Background: PubMed 2591221Krischer JP, Fine EG, Weisfeldt ML, Guerci AD, Nagel E, Chandra N. Comparison of prehospital conventional and simultaneous compression-ventilation cardiopulmonary resuscitation. Crit Care Med. 1989 Dec;17(12):1263-9. doi: 10.1097/00003246-198912000-00005.
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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?
A Phase 3 study testing cardiopulmonary resuscitation in people with Arrhythmia and Cardiovascular Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 Nov 2013. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000502, 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 Nov 2013.