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CompletedNCT03504839DASHUpdated Sep 23, 2021Results posted

Same Day Subcutaneous ICD And Send Home (DASH)

An interventional study of Subcutaneous ICD with same day discharge in Cardiomyopathies and Cardiac Death, Sudden, sponsored by Emile Daoud, MD. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-23.

Sponsored by Emile Daoud, MD · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
53
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

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

  1. 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 1-10
  3. 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.
  5. 30 day readmission rate after discharge following S-ICD implant
  6. 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.

02

Conditions studied

  • Cardiomyopathies
  • Cardiac Death, Sudden

Keywords

  • defibrillator
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
53 participants (actual)

Study arms

  • Other
    Intervention

    S-ICD implantation.

    Device: Subcutaneous ICD with same day discharge

Interventions

  • DeviceSubcutaneous ICD with same day discharge

    Receiving a SICD and discharged the same day

05

What researchers measure

Primary outcomes

  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.

    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

Secondary outcomes

  1. 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.

    Time frame: within 30 days of the procedure

  2. 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.

    Time frame: within 30 days of the procedure

  3. Side Effects Related to Medical Therapy of Protocol.

    Side effects related to medical therapy of protocol.

    Time frame: within 30 days of the procedure

  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 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

  5. 30 Day Readmission Rate After Discharge Following S-ICD Implant

    30 day readmission rate after discharge following S-ICD implant

    Time frame: within 30 days of the procedure

  6. Number of Days That Oral Analgesics Are Used Post Discharge.

    Number of days that oral analgesics are used post discharge.

    Time frame: within 30 days of the procedure

06

Results

Posted Sep 23, 2021

Participant flow

Participant flow — Overall Study
MilestoneIntervention
Started53
Completed49
Not completed4

Outcome measures

PrimaryRate 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.

Time frame:
within 30 days of the procedure
Reported as:
Count of participants · Participants
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.
ParticipantsIntervention
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
SecondaryProcedure 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.

Time frame:
within 30 days of the procedure
Reported as:
Count of participants · Participants
Procedure Complication (Failed Implantation, Infection, Hematoma/Bleeding, Etc…) Within 30 Days of Procedure.
ParticipantsIntervention
Procedure Complication (Failed Implantation, Infection, Hematoma/Bleeding, Etc…) Within 30 Days of Procedure.4
Statistical analysis
  • Intervention · ANOVA · p = <0.01
SecondarySerial 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.

Time frame:
within 30 days of the procedure
Reported as:
Count of participants · Participants
Serial Assessment of Patient Perception of Pain Using the Graded Integer Pain Scale of 0-10
ParticipantsIntervention
Post-Operation Day #0 — mild pain37
Post-Operation Day #0 — moderate pain5
Post-Operation Day #0 — severe pain7
Post-Operation Day #1 — mild pain31
Post-Operation Day #1 — moderate pain11
Post-Operation Day #1 — severe pain7
Post-Operation Day #3 — mild pain39
Post-Operation Day #3 — moderate pain5
Post-Operation Day #3 — severe pain4
Post-Operation Day #14 — mild pain44
Post-Operation Day #14 — moderate pain1
Post-Operation Day #14 — severe pain2
Post-Operation Day #30 — mild pain46
Post-Operation Day #30 — moderate pain1
Post-Operation Day #30 — severe pain1
SecondarySide Effects Related to Medical Therapy of Protocol.

Side effects related to medical therapy of protocol.

Time frame:
within 30 days of the procedure
Reported as:
Count of participants · Participants
Side Effects Related to Medical Therapy of Protocol.
ParticipantsIntervention
Side Effects Related to Medical Therapy of Protocol.0
SecondaryTime 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.

Time frame:
within 30 days of the procedure
Reported as:
Mean · minutes
Time From Beginning of Recovery (Defined as When the Patient Enters the Recovery IPR Room) to the Time of Discharge From the Recovery Unit.
minutesIntervention
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 ± 80
Secondary30 Day Readmission Rate After Discharge Following S-ICD Implant

30 day readmission rate after discharge following S-ICD implant

Time frame:
within 30 days of the procedure
Reported as:
Count of participants · Participants
30 Day Readmission Rate After Discharge Following S-ICD Implant
ParticipantsIntervention
30 Day Readmission Rate After Discharge Following S-ICD Implant2
SecondaryNumber of Days That Oral Analgesics Are Used Post Discharge.

Number of days that oral analgesics are used post discharge.

Time frame:
within 30 days of the procedure
Reported as:
Number · days
Number of Days That Oral Analgesics Are Used Post Discharge.
daysIntervention
Number of Days That Oral Analgesics Are Used Post Discharge.3

Adverse events

Collected over 1 year, 3 months.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Intervention0/49 (0%)0/49 (0%)2/49 (4.1%)
Most frequent other events
Most frequent other events
EventIntervention
Incisional infectionInfections and infestations1/49
Inappropriate S-ICD shocksCardiac disorders1/49

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Intervention
<=18 years0
Between 18 and 65 years45
>=65 years4
Age, Continuous
Age, Continuous(years)Intervention
Mean47 ± 14
Sex: Female, Male
Sex: Female, Male(Participants)Intervention
Female22
Male27
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Intervention
Region of Enrollment
Region of Enrollment(participants)Intervention
United States49
07

Study locations

1 site
  • Ohio State University Medical Center
    Columbus, Ohio 43210, United States
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Dec 6, 2018
  • Informed consent form · Dec 7, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03504839
Lead sponsor
Emile Daoud, MD
Collaborators
Boston Scientific Corporation
Responsible party
Emile Daoud, MD (Sub-Investigator, Ohio State University) — Sponsor-investigator
First posted
Apr 20, 2018
Start date
Jan 15, 2018
Primary completion
Apr 12, 2019
Completion
Apr 12, 2019
Results posted
Sep 23, 2021
Last update
Sep 23, 2021

Study contacts

Toshimasa Okabe, MD
principal investigator · Ohio State University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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