Trial Outcomes & Findings for Same Day Subcutaneous ICD And Send Home (DASH) (NCT NCT03504839)

NCT ID: NCT03504839

Last Updated: 2021-09-23

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 53 participants
• Primary outcome timeframe: within 30 days of the procedure
• Results posted on: 2021-09-23

Participant Flow

Participant milestones

Measure	Intervention S-ICD implantation. Subcutaneous ICD with same day discharge: Receiving a SICD and discharged the same day
Overall Study STARTED	53
Overall Study COMPLETED	49
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Intervention n=49 Participants S-ICD implantation. Subcutaneous ICD with same day discharge: Receiving a SICD and discharged the same day
Age, Categorical <=18 years	0 Participants n=49 Participants
Age, Categorical Between 18 and 65 years	45 Participants n=49 Participants
Age, Categorical >=65 years	4 Participants n=49 Participants
Age, Continuous	47 years STANDARD_DEVIATION 14 • n=49 Participants
Sex: Female, Male Female	22 Participants n=49 Participants
Sex: Female, Male Male	27 Participants n=49 Participants
Region of Enrollment United States	49 participants n=49 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Intervention n=53 Participants S-ICD implantation. Subcutaneous ICD with same day discharge: Receiving a SICD and discharged the same day
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

SECONDARY outcome

Timeframe: within 30 days of the procedure

Procedure complication (failed implantation, infection, hematoma/bleeding, etc…) within 30 days of procedure.

Outcome measures

Measure	Intervention n=53 Participants S-ICD implantation. Subcutaneous ICD with same day discharge: Receiving a SICD and discharged the same day
Procedure Complication (Failed Implantation, Infection, Hematoma/Bleeding, Etc…) Within 30 Days of Procedure.	4 Participants

SECONDARY outcome

Timeframe: within 30 days of the procedure

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

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.

Outcome measures

Measure	Intervention n=49 Participants S-ICD implantation. Subcutaneous ICD with same day discharge: Receiving a SICD and discharged the same day
Serial Assessment of Patient Perception of Pain Using the Graded Integer Pain Scale of 0-10 Post-Operation Day #0 · mild pain	37 Participants
Serial Assessment of Patient Perception of Pain Using the Graded Integer Pain Scale of 0-10 Post-Operation Day #0 · moderate pain	5 Participants
Serial Assessment of Patient Perception of Pain Using the Graded Integer Pain Scale of 0-10 Post-Operation Day #0 · severe pain	7 Participants
Serial Assessment of Patient Perception of Pain Using the Graded Integer Pain Scale of 0-10 Post-Operation Day #1 · mild pain	31 Participants
Serial Assessment of Patient Perception of Pain Using the Graded Integer Pain Scale of 0-10 Post-Operation Day #30 · mild pain	46 Participants
Serial Assessment of Patient Perception of Pain Using the Graded Integer Pain Scale of 0-10 Post-Operation Day #1 · moderate pain	11 Participants
Serial Assessment of Patient Perception of Pain Using the Graded Integer Pain Scale of 0-10 Post-Operation Day #1 · severe pain	7 Participants
Serial Assessment of Patient Perception of Pain Using the Graded Integer Pain Scale of 0-10 Post-Operation Day #3 · mild pain	39 Participants
Serial Assessment of Patient Perception of Pain Using the Graded Integer Pain Scale of 0-10 Post-Operation Day #3 · moderate pain	5 Participants
Serial Assessment of Patient Perception of Pain Using the Graded Integer Pain Scale of 0-10 Post-Operation Day #3 · severe pain	4 Participants
Serial Assessment of Patient Perception of Pain Using the Graded Integer Pain Scale of 0-10 Post-Operation Day #14 · mild pain	44 Participants
Serial Assessment of Patient Perception of Pain Using the Graded Integer Pain Scale of 0-10 Post-Operation Day #14 · moderate pain	1 Participants
Serial Assessment of Patient Perception of Pain Using the Graded Integer Pain Scale of 0-10 Post-Operation Day #14 · severe pain	2 Participants
Serial Assessment of Patient Perception of Pain Using the Graded Integer Pain Scale of 0-10 Post-Operation Day #30 · moderate pain	1 Participants
Serial Assessment of Patient Perception of Pain Using the Graded Integer Pain Scale of 0-10 Post-Operation Day #30 · severe pain	1 Participants

SECONDARY outcome

Timeframe: within 30 days of the procedure

Side effects related to medical therapy of protocol.

Outcome measures

Measure	Intervention n=49 Participants S-ICD implantation. Subcutaneous ICD with same day discharge: Receiving a SICD and discharged the same day
Side Effects Related to Medical Therapy of Protocol.	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Intervention n=49 Participants S-ICD implantation. Subcutaneous ICD with same day discharge: Receiving a SICD and discharged the same day
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 minutes Standard Deviation 80

SECONDARY outcome

Timeframe: within 30 days of the procedure

Population: 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.

30 day readmission rate after discharge following S-ICD implant

Outcome measures

Measure	Intervention n=49 Participants S-ICD implantation. Subcutaneous ICD with same day discharge: Receiving a SICD and discharged the same day
30 Day Readmission Rate After Discharge Following S-ICD Implant	2 Participants

SECONDARY outcome

Timeframe: within 30 days of the procedure

Number of days that oral analgesics are used post discharge.

Outcome measures

Measure	Intervention n=49 Participants S-ICD implantation. Subcutaneous ICD with same day discharge: Receiving a SICD and discharged the same day
Number of Days That Oral Analgesics Are Used Post Discharge.	3 days

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Intervention n=49 participants at risk S-ICD implantation. Subcutaneous ICD with same day discharge: Receiving a SICD and discharged the same day
Infections and infestations Incisional infection	2.0% 1/49 • Number of events 1 • 1 year, 3 months.
Cardiac disorders Inappropriate S-ICD shocks	2.0% 1/49 • Number of events 1 • 1 year, 3 months.

Additional Information

Clinical Research Coordinator - Adrianne Miller

The Ohio State University Medical Center

Phone: 614-688-8252

Email: adrianne.miller3@osumc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place