Early Mobilization for Heart Procedure Recovery
(ZEBRA Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Oregon Health and Science University
Disqualifiers: Arterial access, BMI > 40, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The goal of this study is to understand the effects of early mobilization after a Z stitch procedure in patients undergoing certain heart-related treatments. The investigators want to find out if allowing patients to move around sooner after their procedure can improve their satisfaction and potentially lead to earlier discharge from the hospital.
Type of Study: Clinical Trial
Participant Population/Health Conditions: Patients aged 18-99 undergoing specific heart procedures such as atrial fibrillation treatment, atrial flutter treatment, supraventricular tachycardia treatment, diagnostic electrophysiology studies, AV node ablation, or Watchman device placement.
Main Questions:
Does early mobilization (getting up and moving around sooner) after the Z stitch procedure improve patient satisfaction?
Participants will be divided into two groups, and researchers will compare those who have one hour of bedrest with those who have four hours of bedrest after the Z stitch procedure. The investigators want to see if the shorter bedrest period leads to higher patient satisfaction.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Early Mobilization for Heart Procedure Recovery?
Research shows that early mobilization after heart surgeries, like coronary artery bypass grafting, can improve physical function, such as walking distance, by the time patients leave the hospital. It also suggests that early mobilization can reduce complications and improve emotional recovery without long-term risks.
12345Is early mobilization generally safe for humans after surgery?
Research shows that early mobilization after surgeries, like abdominal and heart procedures, is generally safe and can help with recovery. It may reduce complications and improve emotional well-being, although the best way to implement it can vary.
15678How does the early mobilization treatment differ from other treatments for heart procedure recovery?
Early mobilization after heart procedures is unique because it encourages patients to start moving soon after surgery, which can lead to faster recovery and better long-term outcomes compared to traditional prolonged bed rest. This approach is based on evidence from other surgeries showing that early movement helps improve recovery and return to normal activities.
124910Eligibility Criteria
This trial is for adults aged 18-99 who are undergoing heart procedures like atrial fibrillation/flutter treatment, supraventricular tachycardia treatment, or getting a Watchman device. It's not for those who can't consent, have certain types of arterial access, need large sheaths (>16Fr) for their procedure, have a BMI over 40, or are having lead-extraction.Inclusion Criteria
I am going to the EP lab for an atrial flutter procedure.
I am scheduled for a diagnostic heart rhythm test in the EP lab.
I am scheduled for a procedure to manage my heart's rhythm.
+3 more
Exclusion Criteria
My BMI is over 40.
I am scheduled for or have had a lead extraction procedure.
You have a medical device that requires a large sheath for access.
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Participants undergo the Z stitch procedure with either 1 hour or 4 hours of bed rest, followed by ambulation and Z stitch removal
4.5 hours
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment, including a 30-day phone follow-up to evaluate longer-term outcomes
30 days
1 phone follow-up
Participant Groups
The study tests if early mobilization (moving around sooner) after the Z stitch procedure leads to better patient satisfaction and possibly earlier hospital discharge. Participants will be randomly assigned to either one hour or four hours of bedrest post-procedure to compare outcomes.
2Treatment groups
Experimental Treatment
Active Control
Group I: 1 hour bedrestExperimental Treatment1 Intervention
One hour of bedrest, elevate head of bed to 30 degrees at 30 minutes, ambulate at 60 minutes, Z stitches out at 4 hours, eligible for discharge (if appropriate) at 4.5 hours.
Group II: 4 hour bedrestActive Control1 Intervention
Four hours of bedrest, elevate head of bed to 30 degrees at 2 hours, Z stitches out at 4 hours, ambulate at 4 hours, eligible for discharge at 4.5 hours.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Portland VA Medical CenterPortland, OR
Oregon Health and Science UniversityPortland, OR
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Who Is Running the Clinical Trial?
Oregon Health and Science UniversityLead Sponsor
References
The effect of early mobilization protocols on postoperative outcomes following abdominal and thoracic surgery: A systematic review. [2019]Early mobilization is considered an important element of postoperative care; however, how best to implement this intervention in clinical practice is unknown. This systematic review summarizes the evidence regarding the impact of specific early mobilization protocols on postoperative outcomes after abdominal and thoracic surgery.
Early Mobilization Prescription in Patients Undergoing Cardiac Surgery: Systematic Review. [2022]Early mobilization of patients in the postoperative period of cardiac surgery who are hospitalized in the intensive care unit (ICU) is a practice that has a positive impact.
Effect of Early Mobilization on Physical Function in Patients after Cardiac Surgery: A Systematic Review and Meta-Analysis. [2021]The objective effects of early mobilization on physical function in patients after cardiac surgery remain unknown. The purpose of the present study was to clarify the effects of early mobilization on physical function in patients after cardiac surgery through meta-analysis. Four electronic databases were searched on 2 August 2019. We used search keywords related to "early mobilization", "cardiac surgery", and "randomized controlled trials". All randomized controlled trials conducting early mobilization after cardiac surgery were included. We defined early mobilization as the application of physical activity within the first five postoperative days. Citations and data extraction were independently screened in duplicate by two authors. The meta-analysis was conducted using random-effects modeling with EZR software. The primary outcome was the distance walked during the six-minute walking test at hospital discharge. Six randomized controlled trials comprising 391 patients were included following screening of 591 studies. All studies included coronary artery bypass grafting as the cardiac surgery conducted. Early mobilization started on postoperative days 1-2 and was conducting twice daily. Early mobilization showed a trend of being combined with respiratory exercise or psychoeducation. The meta-analysis showed that the distance walked during the 6-min walking test improved by 54 m (95% confidence interval, 31.1-76.9; I2 = 52%) at hospital discharge. The present study suggested that early mobilization after cardiac surgery may improve physical function at discharge.
[Early mobilization in the acute stage of myocardial infarction long term results]. [2008]A report is presented on the continuation of a controlled study on early mobilization after acute myocardial infarction performed at the Cantonal Hospital of Geneva. Detailed follow-up studies were made in the patients from the original study 4 years on average after the myocardial infarction. It is well known that early mobilization offers many advantages over prolonged bed rest. The present study demonstrates that early mobilization after acute myocardial infarction involves no longterm risks.
[Fast-track cardiac anesthesia and perioperative management appropriate for early rehabilitation after coronary artery bypass graft (CABG) surgery]. [2013]Rapid mobilization and rehabilitation after CABG has a potential benefit of reducing both costs and pulmonary complications (such as atelectasis and pulmonary embolism). Moreover, it improves the patient's emotional recovery. We performed fast-track cardiac anesthesia aiming toward early rehabilitation.
Supervised Immediate Postoperative Mobilization After Elective Colorectal Surgery: A Feasibility Study. [2022]Label="BACKGROUND">Early mobilization is a significant part of the ERAS® Society guidelines, in which patients are recommended to spend 2 h out of bed on the day of surgery. However, it is not yet known how early patients can safely be mobilized after completion of colorectal surgery. The aim of this study was to evaluate the feasibility, and safety of providing almost immediate structured supervised mobilization starting 30 min post-surgery at the postoperative anesthesia care unit (PACU), and to describe reactions to this approach.
Pain and Opioid Consumption and Mobilization after Surgery: Post Hoc Analysis of Two Randomized Trials. [2022]Early mobilization is incorporated into many enhanced recovery pathways. Inadequate analgesia or excessive opioids may restrict postoperative mobilization. The authors tested the hypotheses that in adults recovering from abdominal surgery, postoperative pain and opioid consumption are inversely related to postoperative mobilization, and that postoperative mobilization is associated with fewer potentially related complications.
Early goal-directed mobilization in patients with acute type A aortic dissection: A randomized controlled trial. [2023]To determine the safety and efficacy of early postoperative mobilization in patients who have undergone surgical repair of acute type A aortic dissection.
[Early ambulation and rehabilitation following heart surgery from the viewpoint of the cardiologist for adults]. [2017]Traditional concepts about the early phase of postoperative remobilization after cardiac surgery favor physical inactivity--as did earlier concepts for rehabilitation after myocardial infarction like the armchair treatment philosophy. For an overwhelming majority of our patients, however, this concept does not hold, according to our experience during the last decade. In contrast, we propose a model of stepwise mobilization and rehabilitation starting the first postoperative days. At the end of the first week most patients are able to climb staircases. In the second week group physical therapy can be started. At the 14th postoperative day, discharge from the surgical ward is warranted. During this step of early mobilization some exceptions have to be made and some special aspects have to be considered. Early mobilization must be postponed in patients with overt heart insufficiency, a low ejection fraction, complex ventricular arrhythmias or pericardial effusions. Cautious mobilization is also required in patients with mitral valve replacement and persistent elevation of pulmonary pressure and resistance. This holds also for patients with valve replacement during acute endocarditis, patients with repair of a dissecting aneurysm of the aorta and patients with perioperative myocardial infarction. The stage of early postoperative mobilization usually ends after the second week and is followed by the next step, the rehabilitation phase during weeks 3 to 6. The goals of the rehabilitation program are; increasing the physical fitness of the patient, thereby increasing his self-assurance and self-esteem; establishing a health-education program, increasing the patients health competence and his coping capacities.(ABSTRACT TRUNCATED AT 250 WORDS)
Orthopedic Principles to Facilitate Enhanced Recovery After Cardiac Surgery. [2021]Enhanced recovery after surgery (ERAS) protocols recognize early postoperative mobilization as a driver of faster postoperative recovery, return to normal activities, and improved long-term patient outcomes. For patients undergoing open cardiac surgery, an opportunity for facilitating earlier mobilization and a return to normal activity lies in the use of improved techniques to stabilize the sternal osteotomy. By following the key orthopedic principles of approximation, compression, and rigid fixation, a more nuanced approach to sternal precaution protocols is possible, which may enable earlier patient mobilization, physical rehabilitation, and recovery.