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NCT05743673 · ClinicalTrials.gov registry record
SHAPE Test for Preoperative Risk Stratification
A clinical trial of Perioperative/Postoperative Complications and Aerobic Capacity, sponsored by Yale University.
- Recruiting
- Registry status
- 371
- Enrollment target
- 1
- Study location
NCT05743673: Recruiting study of Perioperative/Postoperative Complications and Aerobic Capacity, sponsored by Yale University.
NCT05743673 is a study of Perioperative/Postoperative Complications and Aerobic Capacity that is actively recruiting participants, run by Yale University. The registered enrollment target is 371 participants, above the 292-participant average among 8 other Perioperative/Postoperative Complications trials with a reported enrollment target (27% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05743673, a study of Perioperative/Postoperative Complications and Aerobic Capacity, is actively recruiting participants, sponsored by Yale University.
- RECRUITING
- Registry status
- 371 participants
- Enrollment target
- 1
- Study location
Study Summary
Primary Objective Characterizing precise functional capacity in surgical patients is critical for risk stratification and identification of patients at high risk for perioperative complications. The primary objective for the study is to evaluate the feasibility of effective subject recruitment of an FDA-approved simplified cardiopulmonary exercise testing apparatus in adults \>60 years old prior to moderate to high-risk surgery. In addition, by development of a validation cohort of older adults, defined as \>60 years old, self-reporting \>4 METS and with a score of \<2 on the revised cardiac risk index (RCRI)1 we will compare its effectiveness when compared to conventional preoperative evaluation measures (METS determination by standard scoring and Duke Activity Status Index) to SHAPE™ testing.
Primary Outcome
The primary objective for the study is a study enrollment rate of 25% of eligible candidates. Within the parameters of a feasibility study, the following questions will also be addressed: * Physical capacity of clinic to handle the number of participants in the study. * Adequate communication and time frame to efficiently perform abbreviated cardiopulmonary exercise testing in high-volume preoperative testing environment. * Adequate software and hardware to capture and use data obtained from a
Conditions Studied
Interventions
- DEVICE Shape II
Study Locations (1)
Connecticut
- Yale New Haven Hospital - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 371 participants |
| Start Date | 2023-05-03 |
| Est. Completion | 2026-05-29 |
What NCT05743673 shows while recruiting
NCT05743673 is an observational study that tracks outcomes without assigning an intervention. The registered 371 participants enrollment target is mid-sized for trials with a published cap, above the 292-participant average among 8 other Perioperative/Postoperative Complications trials with a reported enrollment target (27% higher).
The record links to 2 conditions, with Perioperative/Postoperative Complications appearing as the primary indexed condition, and to 1 intervention - of which Shape II is the first listed.
NCT05743673 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT05743673 about?
NCT05743673 is a clinical study titled "SHAPE Test for Preoperative Risk Stratification". Primary Objective Characterizing precise functional capacity in surgical patients is critical for risk stratification and identification of patients at high risk for perioperative complications. The primary objective for the study is to evaluate the feasibility of effective subject recruitment of an...
What is the current status of trial NCT05743673?
This trial is currently recruiting. The enrollment target is 371 participants. The study started on 2023-05-03. Estimated completion is 2026-05-29.
What conditions does trial NCT05743673 study?
This clinical trial studies the following conditions: Perioperative/Postoperative Complications, Aerobic Capacity.
What interventions are being tested in trial NCT05743673?
The interventions under investigation include: Shape II (DEVICE).
Who is sponsoring clinical trial NCT05743673?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05743673 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05743673's enrollment target sits among peer trials
371 3rd of 8 higher than 6 of 8 other Perioperative/Postoperative Complications trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Perioperative/Postoperative Complications trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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