A Randomized Trial of Lenient Versus Strict Arm Instruction Post Cardiac Device Surgery

Post-Op Complication Clinical Trial

— LENIENT  

Official title:

A Randomized Trial of Lenient Versus Strict Arm Instruction Post Cardiac Device Surgery - LENIENT

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04915261
• Other study ID #: 20210168-01H
• Status: Recruiting
• Phase: Phase 4
• Start date: August 19, 2021
• Est. completion date: June 1, 2025

Study information

• Verified date: May 2024
• Source: Ottawa Heart Institute Research Corporation
• Contact: Tammy Knight
• Phone: 613.696.7000
• Email: tknight[@]ottawaheart.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose and objectives of this study is to investigate whether reducing the existing arm restrictions on patients who receive Cardiac Implantable Electronic Devices (CIED) will result in an improved patient experience post operatively and reduce complication rates. There are multiple and varied arm restriction instructions given to patients receiving CIED's with limited universally accepted protocols or advice on restrictions for patients following surgery.

Restrictions such as arm immobilization, showering and weight lifting, in addition to contradictory advice between various hospitals and physicians, can negatively affect patient quality of life and increase patient anxiety with no current evidence for benefit. A cluster cross over randomized trial has been designed to test the comparative effectiveness of lenient vs strict arm restrictions for all patients receiving implantable devices.

Instructions within both arms of this study are considered within reasonable practice in Canada.

All arm restriction instructions and parameters will be embedded within EPIC, nurses will teach the restriction in addition they will be provide to the patients via printed EPIC discharge summaries. Further links will be embedded in the After Visit Summary (AFS) printouts and my Chart for patients in EPIC. These instructions will be changed every 7 months, as per the crossover design of the trial. Additionally, both arms will utilize interactive voice recognition (IVR) to provide patients with further reminders and instruction on arm restrictions.

All patients are given standard of care instructions for follow up and complication assessment through our device clinic and 24/7 on call nursing program.

Description:

The purpose and objectives of this study is to investigate whether reducing the existing restrictions on patients post CIED will result in an improved patient experience post operatively and reduce complication rates. Results from this study will create standardized, postoperative arm restriction recommendations more uniform between various hospitals.

Hypothesis: The investigators hypothesize that outcomes of the post CIED implanted patients given lenient arm restriction will be non-inferior to those with prolonged arm restriction at reducing a combined primary endpoint of lead dislodgement, device infection, clinically significant pocket hematoma, upper limb DVT and frozen shoulder.

Clinical relevance: The investigators anticipate that patients with minimal (lenient) arm restriction will have similar postoperative complication rates compared to the prolonged arm restriction. Should this hypothesis be proven, this will greatly improve patient quality of life post CIED with less stringent restrictions.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• all patients undergoing device surgery which includes implantation of at least one new endovascular lead

Exclusion Criteria:

• Standalone CIED generator replacement

Related Conditions & MeSH terms

• Post-Op Complication
• Postoperative Complications

Intervention

Behavioral:
• Lenient Arm Restriction
The study will crossover between either strict arm restriction guidelines for patients or lenient arm restrictions.
• Strict Arm Restriction
The study will crossover between either strict arm restriction guidelines for patients or lenient arm restrictions.

Locations

Country	Name	City	State
Canada	University of Ottawa Heart Institute	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Heart Institute Research Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurring within 52 weeks of index surgery a composite of 1) Lead dislodgement 2) Frozen shoulder 3) Upper arm venous thrombosis 4) Clinically significant hematoma formation 5) infection	Definitions of each component of primary outcome: Lead dislodgement; dislodgment requiring surgical repair; Frozen shoulder in this study is defined as Nursing or physician note mention of chronologically related (to index surgery) patient complaint of new or markedly worsened shoulder pain and/or restricted and stiffness of active and passive range of motion; Upper arm venous thrombosis; Clinically significant hematoma is defined as done in BRUISE CONTROL 2 trial: a hematoma that required re-operation and/or resulted in prolongation of hospitalization and/or required interruption of oral anticoagulation; Infection will be categorized into three categories pocket infection, blood stream infection and endocarditis	1 year
Secondary	Rate of hematoma	1. Rate of hematoma (# of clinically significant hematoma / total number of procedures performed for each arm)	1 year
Secondary	Rate of lead dislodgement	2. Rate of lead dislodgement (# of lead dislodgements / total number of new leads placed in each arm) separate by type of lead (RA vs. RV vs. LV)	1 year
Secondary	Rate of frozen shoulder	3. Rate of frozen shoulder (# of frozen shoulders / total number of procedures performed for each arm)	1 year
Secondary	Rates of clinically significant pocket infection	5. Rates of clinically significant pocket infection (# of clinically significant device related infections / total number of procedures performed for each arm)	1 year