Clinical trial NCT04915261: A Randomized Trial of Lenient Versus Strict Arm Instruction Post Cardiac Device Surgery
Official title: A Randomized Trial of Lenient Versus Strict Arm Instruction Post Cardiac Device Surgery - LENIENT
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Post-Op Complication
Keywords: Cardiac
Implantable
Electronic
Device
Arm
Restriction
Post-operative
infection
dislodgement
hematoma
DVT
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
First posted: 2021-06-07
Enrollment: 2500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The trial is a single centre non-inferiority cluster crossover trial. Arm restriction protocol will cross over every 8 months with a one month run-in then 7 months of data collection.
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Standalone CIED generator replacement

Primary outcomes:
measure: 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
timeFrame: 1 year
Secondary outcomes:
measure: Rate of hematoma
timeFrame: 1 year
measure: Rate of lead dislodgement
timeFrame: 1 year
measure: Rate of frozen shoulder
timeFrame: 1 year
measure: Rates of clinically significant pocket infection
timeFrame: 1 year
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
Study officials:
affiliation: Ottawa Heart Institute Research Corporation
name: David Birnie
role: PRINCIPAL_INVESTIGATOR
References: