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
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.
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
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.
Exclusion Criteria:
S-ICD implantation.
Device: 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.
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
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
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
Side Effects Related to Medical Therapy of Protocol.
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 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
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.
Number of days that oral analgesics are used post discharge.
Time frame: within 30 days of the procedure
| Milestone | Intervention |
|---|---|
| Started | 53 |
| Completed | 49 |
| Not completed | 4 |
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.
| Participants | Intervention |
|---|---|
| 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 |
Procedure complication (failed implantation, infection, hematoma/bleeding, etc...) within 30 days of procedure.
| Participants | Intervention |
|---|---|
| Procedure Complication (Failed Implantation, Infection, Hematoma/Bleeding, Etc…) Within 30 Days of Procedure. | 4 |
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.
| Participants | Intervention |
|---|---|
| Post-Operation Day #0 — mild pain | 37 |
| Post-Operation Day #0 — moderate pain | 5 |
| Post-Operation Day #0 — severe pain | 7 |
| Post-Operation Day #1 — mild pain | 31 |
| Post-Operation Day #1 — moderate pain | 11 |
| Post-Operation Day #1 — severe pain | 7 |
| Post-Operation Day #3 — mild pain | 39 |
| Post-Operation Day #3 — moderate pain | 5 |
| Post-Operation Day #3 — severe pain | 4 |
| Post-Operation Day #14 — mild pain | 44 |
| Post-Operation Day #14 — moderate pain | 1 |
| Post-Operation Day #14 — severe pain | 2 |
| Post-Operation Day #30 — mild pain | 46 |
| Post-Operation Day #30 — moderate pain | 1 |
| Post-Operation Day #30 — severe pain | 1 |
Side effects related to medical therapy of protocol.
| Participants | Intervention |
|---|---|
| Side Effects Related to Medical Therapy of Protocol. | 0 |
Time from beginning of recovery (defined as when the patient enters the recovery IPR room) to the time of discharge from the recovery unit.
| minutes | Intervention |
|---|---|
| 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 |
30 day readmission rate after discharge following S-ICD implant
| Participants | Intervention |
|---|---|
| 30 Day Readmission Rate After Discharge Following S-ICD Implant | 2 |
Number of days that oral analgesics are used post discharge.
| days | Intervention |
|---|---|
| Number of Days That Oral Analgesics Are Used Post Discharge. | 3 |
Collected over 1 year, 3 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention | 0/49 (0%) | 0/49 (0%) | 2/49 (4.1%) |
| Event | Intervention |
|---|---|
| Incisional infectionInfections and infestations | 1/49 |
| Inappropriate S-ICD shocksCardiac disorders | 1/49 |
| Age, Categorical(Participants) | Intervention |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 45 |
| >=65 years | 4 |
| Age, Continuous(years) | Intervention |
|---|---|
| Mean | 47 ± 14 |
| Sex: Female, Male(Participants) | Intervention |
|---|---|
| Female | 22 |
| Male | 27 |
| Race and Ethnicity Not Collected(Participants) | Intervention |
|---|
| Region of Enrollment(participants) | Intervention |
|---|---|
| United States | 49 |
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