CardiomyopathiesDASHNCT03504839
Same Day Subcutaneous ICD And Send Home (DASH)
A study testing Subcutaneous ICD with same day discharge in people with Cardiomyopathies and Cardiac Death, Sudden, run by Emile Daoud, MD at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiomyopathies, Cardiac Death, Sudden
- What is being tested?
- Subcutaneous ICD with same day discharge
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2018to 12 Apr 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Medical Center
Columbus, Ohio, 43210
About this study
Official title: Same Day Subcutaneous ICD And Send Home
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.
Read the detailed description
This is a prospective, nonrandomized, descriptive, single center study designed to assess the rate of successful completion of the study protocol in consecutive patients undergoing S-ICD implantation.
Objectives To prospectively evaluate the same day discharge protocol for patients undergoing S-ICD implantation.
Primary Endpoint 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.
Secondary Endpoints
- Procedure complication (failed implantation, infection, hematoma/bleeding, etc…) within 30 days of procedure.
- Serial assessment of patient perception of pain using the graded integer pain scale of 1-10
- Side effects related to medical therapy of protocol.
- Time from beginning of recovery (defined as when the patient enters the recovery IPR room) to the time of discharge from the recovery unit.
- 30 day readmission rate after discharge following S-ICD implant
- Number of days that oral analgesics are used post discharge.
Patients will be approached for participation in the study once they have been consented for implantation of the clinically indicated S-ICD
.
Pre-procedure analgesia will be given to each patient as follows:
Acetaminophen 975 mg PO x 1 will be administered 1-2 hours prior to the procedure. and Oxycodone 10 mg PO x 1 will be administered 1-2 hours prior to the procedure. Anesthesia will be provided by anesthesiology team as MAC or general anesthesia. Local subcutaneous anesthetic will be a 50:50 mixture of 2% lidocaine and 0.5% bupivacaine; which will result in a concentration of 1% lidocaine and 0.25% bupivacaine.
Starting at ≈2 hours post procedure, the patient will then enter the "Preparation for Discharge" phase. The modified Aldrete scoring system will be used to determine eligibility for discharge home.Patients with an Aldrete score ≥ 9 will be deemed eligible for discharge home.
Additional standard ambulatory discharge criteria per the OSUWMC postanesthesia care policy statement will be applied by the nursing team, akin to all ambulatory surgery patients at OSUWMC. If the above discharge parameters (DP) are not meet, the patient will be reassessed every 30 minutes until parameters are satisfied. Once the patient satisfies the DP, the patient will complete the Pain Perception Questionnaire and be assessed for ambulation, eating/drinking and for understanding of post discharge instructions. The electrophysiology device nursing staff will review management of the S-ICD incision, device and post discharge care instructions with the patient and with the accompanying family member(s)/friend. The patient will be given instructions regarding management of pain and will be provided the following prescription for outpatient pain control Percocet 5mg/325 mg (1 tablet every 6 hours). A 2-day supply will be given.
Also, the patient will be provided a phone number to contact during business hours as well as for after hours to address questions/concerns.
The electrophysiology nursing staff will contact the patient the following day and again at about 3 days post discharge to administer the Pain Perception Questionnaire as well as to address any patient questions. The patient will then be evaluated in the Device Clinic about 10 days post implantation. The Pain Perception questionnaire will be administered and assessment of the incision and S-ICD will be completed. The last Pain Perception questionnaire will be obtained by telephone at about 30 days post implantation.
- Conditions
- Cardiomyopathies, Cardiac Death, Sudden
- Being tested
- Subcutaneous ICD with same day discharge
- Keywords
- defibrillator
- Medical subject headings
- Cardiomyopathies, Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcutaneous ICD with same day dischargeDevice
Receiving a SICD and discharged the same day
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | S-ICD implantation. Receives: Device: Subcutaneous ICD with same day discharge |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: within 30 days of the procedure
Secondary outcomes (6)
Procedure Complication (Failed Implantation, Infection, Hematoma/Bleeding, Etc…) Within 30 Days of Procedure.
Procedure complication (failed implantation, infection, hematoma/bleeding, etc…) within 30 days of procedure.
Measured: within 30 days of the procedure
Serial Assessment of Patient Perception of Pain Using the Graded Integer Pain Scale of 0-10
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.
Measured: within 30 days of the procedure
Side Effects Related to Medical Therapy of Protocol.
Side effects related to medical therapy of protocol.
Measured: 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.
Time from beginning of recovery (defined as when the patient enters the recovery IPR room) to the time of discharge from the recovery unit.
Measured: within 30 days of the procedure
30 Day Readmission Rate After Discharge Following S-ICD Implant
30 day readmission rate after discharge following S-ICD implant
Measured: within 30 days of the procedure
Number of Days That Oral Analgesics Are Used Post Discharge.
Number of days that oral analgesics are used post discharge.
Measured: within 30 days of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2018
- Study start15 Jan 2018
- Primary completion12 Apr 2019
- Study completion12 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CardiomyopathiesStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Consecutive patients consented for SICD as per standard indications for device implantation
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emile Daoud, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor-investigator, Emile Daoud, MD, Ohio State University
- Investigators
- Toshimasa Okabe, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03504839
- Sponsor's protocol ID
- 2017H00451
- Acronym
- DASH
- Status last verified
- Sep 2021
- First submitted
- 4 Apr 2018
- Last updated
- 23 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Same Day Subcutaneous ICD And Send Home
- ClinicalTrials.gov ID
- NCT03504839
- Acronym / sponsor ID
- DASH / 2017H00451
- Conditions
- Cardiomyopathies, Cardiac Death, Sudden
- Keywords
- defibrillator
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Emile Daoud, MDUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 12 Apr 2019 (actual)
- Study completion
- 12 Apr 2019 (actual)
- First posted
- 20 Apr 2018 (actual)
- Results
- Posted 23 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, nonrandomized, descriptive, single center study designed to assess the rate of successful completion of the study protocol in consecutive patients undergoing S-ICD implantation.
Objectives To prospectively evaluate the same day discharge protocol for patients undergoing S-ICD implantation.
Primary Endpoint 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.
Secondary Endpoints
- Procedure complication (failed implantation, infection, hematoma/bleeding, etc…) within 30 days of procedure.
- Serial assessment of patient perception of pain using the graded integer pain scale of 1-10
- Side effects related to medical therapy of protocol.
- Time from beginning of recovery (defined as when the patient enters the recovery IPR room) to the time of discharge from the recovery unit.
- 30 day readmission rate after discharge following S-ICD implant
- Number of days that oral analgesics are used post discharge.
Patients will be approached for participation in the study once they have been consented for implantation of the clinically indicated S-ICD
.
Pre-procedure analgesia will be given to each patient as follows:
Acetaminophen 975 mg PO x 1 will be administered 1-2 hours prior to the procedure. and Oxycodone 10 mg PO x 1 will be administered 1-2 hours prior to the procedure. Anesthesia will be provided by anesthesiology team as MAC or general anesthesia. Local subcutaneous anesthetic will be a 50:50 mixture of 2% lidocaine and 0.5% bupivacaine; which will result in a concentration of 1% lidocaine and 0.25% bupivacaine.
Starting at ≈2 hours post procedure, the patient will then enter the "Preparation for Discharge" phase. The modified Aldrete scoring system will be used to determine eligibility for discharge home.Patients with an Aldrete score ≥ 9 will be deemed eligible for discharge home.
Additional standard ambulatory discharge criteria per the OSUWMC postanesthesia care policy statement will be applied by the nursing team, akin to all ambulatory surgery patients at OSUWMC. If the above discharge parameters (DP) are not meet, the patient will be reassessed every 30 minutes until parameters are satisfied. Once the patient satisfies the DP, the patient will complete the Pain Perception Questionnaire and be assessed for ambulation, eating/drinking and for understanding of post discharge instructions. The electrophysiology device nursing staff will review management of the S-ICD incision, device and post discharge care instructions with the patient and with the accompanying family member(s)/friend. The patient will be given instructions regarding management of pain and will be provided the following prescription for outpatient pain control Percocet 5mg/325 mg (1 tablet every 6 hours). A 2-day supply will be given.
Also, the patient will be provided a phone number to contact during business hours as well as for after hours to address questions/concerns.
The electrophysiology nursing staff will contact the patient the following day and again at about 3 days post discharge to administer the Pain Perception Questionnaire as well as to address any patient questions. The patient will then be evaluated in the Device Clinic about 10 days post implantation. The Pain Perception questionnaire will be administered and assessment of the incision and S-ICD will be completed. The last Pain Perception questionnaire will be obtained by telephone at about 30 days post implantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Consecutive patients consented for SICD as per standard indications for device implantation
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Device: Subcutaneous ICD with same day dischargeS-ICD implantation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
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 |
|---|---|---|
| Subcutaneous ICD with same day dischargeReceiving a SICD and discharged the same day | Device | Intervention |
Primary outcome
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.
6 secondary outcomes
Procedure Complication (Failed Implantation, Infection, Hematoma/Bleeding, Etc…) Within 30 Days of Procedure.
Time frame: within 30 days of the procedure
Serial Assessment of Patient Perception of Pain Using the Graded Integer Pain Scale of 0-10
Time frame: within 30 days of the procedure
Side Effects Related to Medical Therapy of Protocol.
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.
Time frame: within 30 days of the procedure
30 Day Readmission Rate After Discharge Following S-ICD Implant
Time frame: within 30 days of the procedure
Number of Days That Oral Analgesics Are Used Post Discharge.
Time frame: within 30 days of the procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Toshimasa Okabe, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subcutaneous ICD with same day discharge in people with Cardiomyopathies and Cardiac Death, Sudden, run by Emile Daoud, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. 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 23 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Sep 2021.