Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Other | S-ICD implantation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subcutaneous ICD with same day discharge | Device | Receiving a SICD and discharged the same day |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | within 30 days of the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | within 30 days of the procedure |
| Serial Assessment of Patient Perception of Pain Using the Graded Integer Pain Scale of 0-10 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Toshimasa Okabe, MD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | S-ICD implantation. Subcutaneous ICD with same day discharge: Receiving a SICD and discharged the same day |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | S-ICD implantation. Subcutaneous ICD with same day discharge: Receiving a SICD and discharged the same day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | within 30 days of the procedure |
|
|
1 year, 3 months.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | S-ICD implantation. Subcutaneous ICD with same day discharge: Receiving a SICD and discharged the same day |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Incisional infection | Infections and infestations | Non-systematic Assessment | Incisional infection successfully treated with oral antibiotics. |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Coordinator - Adrianne Miller | The Ohio State University Medical Center | 614-688-8252 | adrianne.miller3@osumc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 6, 2018 | Mar 12, 2021 | Prot_SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 7, 2018 | Feb 1, 2021 | ICF_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D016757 | Death, Sudden, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D006323 | Heart Arrest |
| D003645 | Death, Sudden |
Not provided
Not provided
Consecutive patients consented for SICD as per standard indications for device implantation
Not provided
Not provided
Not provided
Not provided
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. |
| within 30 days of the procedure |
| Side Effects Related to Medical Therapy of Protocol. | Side effects related to medical therapy of protocol. | 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. | 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 | 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. | within 30 days of the procedure |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | within 30 days of the procedure |
|
|
|
|
| Secondary | 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. | Patient's did not always answer/call back for their follow-up phone calls. | Posted | Count of Participants | Participants | within 30 days of the procedure |
|
|
|
| Secondary | Side Effects Related to Medical Therapy of Protocol. | Side effects related to medical therapy of protocol. | Posted | Count of Participants | Participants | within 30 days of the procedure |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | minutes | within 30 days of the procedure |
|
|
|
| Secondary | 30 Day Readmission Rate After Discharge Following S-ICD Implant | 30 day readmission rate after discharge following S-ICD implant | 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. | Posted | Count of Participants | Participants | within 30 days of the procedure |
|
|
|
| Secondary | Number of Days That Oral Analgesics Are Used Post Discharge. | Number of days that oral analgesics are used post discharge. | Posted | Number | days | within 30 days of the procedure |
|
|
|
| 0 |
| 49 |
| 0 |
| 49 |
| 2 |
| 49 |
|
| Inappropriate S-ICD shocks | Cardiac disorders | Non-systematic Assessment | Inappropriate shocks due to oversensing, leading to S-ICD removal. |
|
Not provided
Not provided
| D003643 |
| Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| severe pain |
|
| Post-Operation Day #1 |
|
|
| Post-Operation Day #3 |
|
|
| Post-Operation Day #14 |
|
|
| Post-Operation Day #30 |
|
|