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Evaluation of SC-V Versus Conventional CPR

Primary Purpose

Arrhythmia, Cardiovascular Diseases, Heart Arrest

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
cardiopulmonary resuscitation
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arrhythmia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Men, women, and children in cardiac arrest for which CPR was initiated in ten minutes or less from the time of arrest.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 27, 1999
    Last Updated
    November 25, 2013
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00000502
    Brief Title
    Evaluation of SC-V Versus Conventional CPR
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2000
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1981 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    June 1985 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Arrhythmia, Cardiovascular Diseases, Heart Arrest, Heart Diseases, Myocardial Infarction, Ventricular Fibrillation, Cerebral Anoxia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Crossover Assignment

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    cardiopulmonary resuscitation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Men, women, and children in cardiac arrest for which CPR was initiated in ten minutes or less from the time of arrest.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    2591221
    Citation
    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.
    Results Reference
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    Evaluation of SC-V Versus Conventional CPR

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