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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

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.

  1. First posted28 Oct 1999 (estimated)
  2. Study startSep 1981
  3. Study completionJun 1985

Resources

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
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

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.

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Evaluation of SC-V Versus Conventional CPR | AzTrials