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Same Day Subcutaneous ICD And Send Home (DASH) (DASH)

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ClinicalTrials.gov Identifier: NCT03504839
Recruitment Status : Recruiting
First Posted : April 20, 2018
Last Update Posted : April 20, 2018
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
Emile Daoud, MD, Ohio State University

Brief Summary:

Design: Prospective, non-randomized single center study at The Ohio State University Wexner Medical Center.

Purpose: The purpose of this study is to prospectively evaluate a specific analgesia protocol designed to allow for same day discharge following implantation of the subcutaneous implantable cardiac defibrillator (S-ICD) Enrollment: Up to 40 subjects will be enrolled. Subject Population: Consecutive patients undergoing S-ICD implantation under general anesthesia or monitored anesthesia care.

Endpoints: Rate of successful completion of the protocol; Procedural complications; Serial assessment of patient perception of pain.


Condition or disease Intervention/treatment Phase
Cardiomyopathies Cardiac Death, Sudden Device: Subcutaneous ICD with same day discharge Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Consecutive patients consented for SICD as per standard indications for device implantation
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Same Day Subcutaneous ICD And Send Home
Actual Study Start Date : January 15, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : September 1, 2019

Arm Intervention/treatment
Intervention
S-ICD implantation.
Device: Subcutaneous ICD with same day discharge
Receiving a SICD and discharged the same day




Primary Outcome Measures :
  1. Rate of successful completion of S-ICD implantation and discharge of the patient on the same day the device is implanted using the analgesia protocol. [ Time Frame: within 30 days of the procedure ]
    Rate of successful completion of S-ICD implantation and discharge of the patient on the same day the device is implanted using the analgesia protocol.


Secondary Outcome Measures :
  1. Procedure complication (failed implantation, infection, hematoma/bleeding, etc…) within 30 days of procedure. [ Time Frame: within 30 days of the procedure ]
    Procedure complication (failed implantation, infection, hematoma/bleeding, etc…) within 30 days of procedure.

  2. Serial assessment of patient perception of pain using the graded integer pain scale of 0-10 [ Time Frame: within 30 days of the procedure ]
    Serial assessment of patient perception of pain using the graded integer Numeric Pain Rating Scale (NPRS) of 0-10. This is an unidimensional measure of pain intensity in adults. Zero being no pain, 1-3 being mild pain, 4-6 being moderate pain, 7-10 being severe pain.

  3. Side effects related to medical therapy of protocol. [ Time Frame: within 30 days of the procedure ]
    Side effects related to medical therapy of protocol.

  4. Time from beginning of recovery (defined as when the patient enters the recovery IPR room) to the time of discharge from the recovery unit. [ Time Frame: within 30 days of the procedure ]
    Time from beginning of recovery (defined as when the patient enters the recovery IPR room) to the time of discharge from the recovery unit.

  5. 30 day readmission rate after discharge following S-ICD implant [ Time Frame: within 30 days of the procedure ]
    30 day readmission rate after discharge following S-ICD implant

  6. Number of days that oral analgesics are used post discharge. [ Time Frame: within 30 days of the procedure ]
    Number of days that oral analgesics are used post discharge.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient consented for implantation of S-ICD.
  • Ambulatory/outpatient patient coming to the hospital setting solely for implantation of S-ICD
  • Patient agrees to participate and is able to comply with the defined study protocol, including assistance for home care and transportation for the first ≈12-18 hours post discharge, and compliance with the required follow up.

Exclusion Criteria:

  • Inability or unwillingness to provide informed consent
  • Patients who, for any reason, was hospitalized or in an emergency department the day prior to the S-ICD implantation, including patients transferred for S-ICD implantation
  • Patients in which the hemodynamics are dependent upon intravenous pressors infusing at the time of device implantation or mechanical support, inclusive of left ventricular assist device and intravenous devices (balloon pump, Impella device).
  • Age < 18 years.
  • Pregnancy.
  • Currently incarcerated.
  • Hypoxia (room air oxygen <91%) or acutely short of breath.
  • Hypotension (Systolic blood pressure <90) unless this is patient's typical blood pressure).
  • Bradycardia (heart rate <45bpm, unless this is patient's typical resting heart rate).
  • Acute electrolyte disorder that cannot be easily corrected (e.g., potassium supplementations) based upon Chem 6 values obtained on day of procedure.
  • Presence of a fever.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03504839


Contacts
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Contact: Emile Daoud, MD 614 685 4394 emile.daoud@osumc.edu
Contact: Deanna Golden-Kreutz, PhD 614 247 7811 deanna.golden-kreutz@osumc.edu

Locations
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United States, Ohio
Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Emile Daoud, MD    614-685-4394    emile.daoud@osumc.edu   
Principal Investigator: Toshimasa Okabe, MD         
Sponsors and Collaborators
Emile Daoud, MD
Boston Scientific Corporation
Investigators
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Principal Investigator: Toshimasa Okabe, MD Ohio State University

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Responsible Party: Emile Daoud, MD, Sub-Investigator, Ohio State University
ClinicalTrials.gov Identifier: NCT03504839     History of Changes
Other Study ID Numbers: 2017H00451
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Emile Daoud, MD, Ohio State University:
defibrillator

Additional relevant MeSH terms:
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Cardiomyopathies
Death, Sudden, Cardiac
Death
Death, Sudden
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Heart Arrest