N/A
N=53
Same Day Subcutaneous ICD And Send Home (DASH)
Cardiomyopathies · Cardiac Death, Sudden
Bottom Line
View on ClinicalTrials.gov: NCT03504839 ↗Enrolled (actual)
53
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcome: Primary: 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. — 49 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Subcutaneous ICD with same day discharge (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Emile Daoud, MD
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
49 | — |
| SECONDARY Procedure Complication (Failed Implantation, Infection, Hematoma/Bleeding, Etc…) Within 30 Days of Procedure. |
4 | <0.01 sig |
| SECONDARY Serial Assessment of Patient Perception of Pain Using the Graded Integer Pain Scale of 0-10 |
37; 5; 7; 31; 11; 7 | — |
| SECONDARY Side Effects Related to Medical Therapy of Protocol. |
— | — |
| SECONDARY Time From Beginning of Recovery (Defined as When the Patient Enters the Recovery IPR Room) to the Time of Discharge From the Recovery Unit. |
534 | — |
| SECONDARY 30 Day Readmission Rate After Discharge Following S-ICD Implant |
2 | — |
| SECONDARY Number of Days That Oral Analgesics Are Used Post Discharge. |
3 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT03504839). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.