Same Day Subcutaneous ICD And Send Home (DASH)

• Sponsor: Emile Daoud, MD (Other)
• Overall Status: Completed
• CT.gov ID: NCT03504839
• Collaborator: Boston Scientific Corporation (Industry)
• Enrollment: 53
• Location: 1
• Arm: 1
• Actual Duration (Months): 14.9
• Patients Per Site Per Month: 3.6

Study Details

Study Description

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	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 53 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Consecutive patients consented for SICD as per standard indications for device implantationConsecutive 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: Jan 15, 2018
• Actual Primary Completion Date: Apr 12, 2019
• Actual Study Completion Date: Apr 12, 2019

Arms and Interventions

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

Outcome Measures

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. [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. [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 [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. [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. [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 [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. [within 30 days of the procedure]

   Number of days that oral analgesics are used post discharge.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ohio State University Medical Center	Columbus	Ohio	United States	43210

Sponsors and Collaborators

• Emile Daoud, MD
• Boston Scientific Corporation

Investigators

• Principal Investigator: Toshimasa Okabe, MD, Ohio State University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 6, 2018
• Informed Consent Form - Dec 7, 2018

More Information

Publications

None provided.

• Responsible Party: Emile Daoud, MD, Sub-Investigator, Ohio State University
• ClinicalTrials.gov Identifier: NCT03504839
• Other Study ID Numbers: 2017H00451
• First Posted: Apr 20, 2018
• Last Update Posted: Sep 23, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Emile Daoud, MD, Sub-Investigator, Ohio State University: defibrillator
• Additional relevant MeSH terms: Cardiomyopathies; Death, Sudden, Cardiac; Death; Death, Sudden

Study Results

Participant Flow

Arm/Group Title	Intervention
Arm/Group Description	S-ICD implantation. Subcutaneous ICD with same day discharge: Receiving a SICD and discharged the same day
Period Title: Overall Study
STARTED	53
COMPLETED	49
NOT COMPLETED	4

Baseline Characteristics

Arm/Group Title	Intervention
Arm/Group Description	S-ICD implantation. Subcutaneous ICD with same day discharge: Receiving a SICD and discharged the same day
Overall Participants	49
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	45 91.8%
>=65 years	4 8.2%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	47 (14)
Sex: Female, Male (Count of Participants)
Female	22 44.9%
Male	27 55.1%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States	49 100%

Outcome Measures

1. Primary Outcome

Title	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.
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention
Arm/Group Description	S-ICD implantation. Subcutaneous ICD with same day discharge: Receiving a SICD and discharged the same day
Measure Participants	53
Count of Participants [Participants]	49 100%

2. Secondary Outcome

Title	Procedure Complication (Failed Implantation, Infection, Hematoma/Bleeding, Etc…) Within 30 Days of Procedure.
Description	Procedure complication (failed implantation, infection, hematoma/bleeding, etc…) within 30 days of procedure.
Time Frame	within 30 days of the procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention
Arm/Group Description	S-ICD implantation. Subcutaneous ICD with same day discharge: Receiving a SICD and discharged the same day
Measure Participants	53
Count of Participants [Participants]	4 8.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments
	Method	ANOVA
	Comments

3. Secondary Outcome

Title	Serial Assessment of Patient Perception of Pain Using the Graded Integer Pain Scale of 0-10
Description	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

Outcome Measure Data

Analysis Population Description

Patient's did not always answer/call back for their follow-up phone calls.

Arm/Group Title	Intervention
Arm/Group Description	S-ICD implantation. Subcutaneous ICD with same day discharge: Receiving a SICD and discharged the same day
Measure Participants	49
mild pain	37 75.5%
moderate pain	5 10.2%
severe pain	7 14.3%
mild pain	31 63.3%
moderate pain	11 22.4%
severe pain	7 14.3%
mild pain	39 79.6%
moderate pain	5 10.2%
severe pain	4 8.2%
mild pain	44 89.8%
moderate pain	1 2%
severe pain	2 4.1%
mild pain	46 93.9%
moderate pain	1 2%
severe pain	1 2%

4. Secondary Outcome

Title	Side Effects Related to Medical Therapy of Protocol.
Description	Side effects related to medical therapy of protocol.
Time Frame	within 30 days of the procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention
Arm/Group Description	S-ICD implantation. Subcutaneous ICD with same day discharge: Receiving a SICD and discharged the same day
Measure Participants	49
Count of Participants [Participants]	0 0%

5. Secondary Outcome

Title	Time From Beginning of Recovery (Defined as When the Patient Enters the Recovery IPR Room) to the Time of Discharge From the Recovery Unit.
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention
Arm/Group Description	S-ICD implantation. Subcutaneous ICD with same day discharge: Receiving a SICD and discharged the same day
Measure Participants	49
Mean (Standard Deviation) [minutes]	534 (80)

6. Secondary Outcome

Title	30 Day Readmission Rate After Discharge Following S-ICD Implant
Description	30 day readmission rate after discharge following S-ICD implant
Time Frame	within 30 days of the procedure

Outcome Measure Data

Analysis Population Description

There were 2 unplanned healthcare visits within 30 days of implantation conclusively related to S-ICD implantation due to incisional infection successfully treated with oral antibiotics and inappropriate shocks due to oversensing, leading to S-ICD removal. Neither of these complications, however, would have been prevented even if they had stayed overnight in the hospital following outpatient S-ICD implantation.

Arm/Group Title	Intervention
Arm/Group Description	S-ICD implantation. Subcutaneous ICD with same day discharge: Receiving a SICD and discharged the same day
Measure Participants	49
Count of Participants [Participants]	2 4.1%

7. Secondary Outcome

Title	Number of Days That Oral Analgesics Are Used Post Discharge.
Description	Number of days that oral analgesics are used post discharge.
Time Frame	within 30 days of the procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention
Arm/Group Description	S-ICD implantation. Subcutaneous ICD with same day discharge: Receiving a SICD and discharged the same day
Measure Participants	49
Number [days]	3

Adverse Events

Time Frame	1 year, 3 months.
Arm/Group Title	Intervention
Arm/Group Description	S-ICD implantation. Subcutaneous ICD with same day discharge: Receiving a SICD and discharged the same day
All Cause Mortality
	Intervention
	Affected / at Risk (%)	# Events
Total	0/49 (0%)
Serious Adverse Events
	Intervention
	Affected / at Risk (%)	# Events
Total	0/49 (0%)
Other (Not Including Serious) Adverse Events
	Intervention
	Affected / at Risk (%)	# Events
Total	2/49 (4.1%)
Cardiac disorders
Inappropriate S-ICD shocks	1/49 (2%)	1
Infections and infestations
Incisional infection	1/49 (2%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.