New Haven, CTNCT05743673Now EnrollingIRB Ready

Perioperative/Postoperative Complications Clinical Trial in New Haven, CT

Access cutting-edge perioperative/postoperative complications treatment through this clinical trial at a research site in New Haven. Study-provided care at no cost to qualified participants.

Sponsored by Yale University

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Expert Care in New Haven

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IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related perioperative/postoperative complications treatment provided free

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Why Participate?

  • No-Cost Study Care

  • Local to New Haven

    Convenient for CT residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit New Haven site if eligible
  4. 4Begin participation

About This Perioperative/Postoperative Complications Study in New Haven

This study is looking at whether a simplified exercise test called the SHAPE-HF cardiopulmonary testing system can be used before surgery in older adults. Doctors often need to know how well a patient's heart, lungs, and body handle physical activity before moderate- to high-risk surgery. This information may help them better understand a patient's fitness for surgery and possible risk of complications afterward. The study will enroll adults older than 60 years who are being evaluated before planned moderate- to high-risk noncardiac surgery. The first goal is to determine if this was feasible in older adults and to learn whether patients can be successfully recruited to complete this pre-surgery test. Secondly, the study will also look at how results from the SHAPE-HF system compare with common ways doctors now estimate fitness, such as asking patients about their physical activity and using a standard questionnaire. Participants will attend one in-person study visit lasting about 35 minutes. During that visit, they will answer questions about their activity level and complete testing with the SHAPE-HF system. The test uses short periods of lower-intensity exercise to estimate aerobic fitness. After the visit, participants will be contacted by phone about 24 hours later to check for any problems related to the study test. Lastly, researchers will also review information from the medical record for 30 days after surgery to see whether test results are related to recovery, short-term health problems after surgery, or major complications. No extra surgery or change in planned medical care is part of this study. The information learned may help improve how doctors evaluate older adults before surgery in the future.

Sponsor: Yale University

Who Can Participate

Inclusion Criteria

Aged \>60 years
Scheduled for pre-surgical evaluation for moderate to high-risk surgical procedure.
RCRI \<2 based on screening of preoperative co-morbidities.
Provision of signed and dated informed consent form

Exclusion Criteria

Age \<60 years old
Subjective METS \<4
Inability to give independent informed consent
Revised Cardiac Risk Index (RCRI) \>2
Neurological impairment with motor limitations
Mental impairment leading to inability to cooperate
Recent NSTEMI or STEMI type myocardial infarction (within 6 months)
Angina (stable or unstable, within 6 months)
Uncorrected severe valvular heart disease (severe aortic, tricuspid, or mitral stenosis)
Recent exacerbation of congestive heart failure (requiring hospitalization, within 6 months)
Acute pulmonary embolism or deep vein thrombosis (within past 6 months)
Uncontrolled pulmonary edema
Uncontrolled symptomatic arrhythmias
Active endocarditis
Acute myocarditis or pericarditis
Active wheezing or home oxygen use
Recent exacerbation of chronic obstructive pulmonary disease or asthma or pneumonia (requiring hospitalization, within 6 months)
Inability to perform components of the SHAPE test (severe hip flexion limitation, severe osteoarthritis of knee or hip, limb immobilization, ambulation with a walker, can or crutches, baseline balance irregularities
Diagnosis of vertigo
Known allergic reactions to components of the SHAPE medical system apparatus disposable mouthpiece.
Active enrollment in an interventional clinical trial within the enrollment period of the study.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in New Haven?

Yes, this clinical trial (NCT05743673) has an active research site in New Haven, CT that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Perioperative/Postoperative Complications Treatment Options in New Haven, CT

If you're searching for perioperative/postoperative complications treatment options in New Haven, CT, this clinical trial (NCT05743673) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our New Haven research site is actively enrolling participants for this clinical trial. You'll receive care from experienced perioperative/postoperative complications specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all perioperative/postoperative complications clinical trials near you to find additional studies recruiting in your area.

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