Pulmonary Embolism Subacute Massive
Conditions
Keywords
PERT, Artificial Intelligence
Brief summary
Pulmonary embolism (PE) remains a high mortality and morbidity disease state. The investigators have previously shown that use of a Pulmonary Embolism Response Team (PERT) can improve overall readmission, bleeding, and mortality outcomes. Unfortunately, PERT may still be underutilized from a national standpoint and may not be readily available in underserved areas. The use of artificial intelligence (AI) may help streamline and systematically ensure unbiased mechanism for activation of PERT for discussion of patients with siginficant clot burden and hemodynamic abnormalities. AI algorithms have been FDA approved for use of triage of the PE patient. The institutional PERT program will adapt the use of an AI algorithm for activation as routine care; the efficiency of activation will be compared to our retrospective historical comparison for efficiency and appropriateness of activation. The active phase of the study is designed to further differentiate between patients who are considered to be intermediate-high risk category but yet do not clearly qualify for invasive therapy (catheter-directed therapy, systemic thrombolysis, or invasive hemodynamic support). These patients will undergo walking test to further understand noninvasive hemodynamic compromise and undergo 2:1 randomization to early-invasive strategy versus mtranditional medical therapy.
Interventions
DIAGNOSTIC_TESTWalking test
PERT will be activated by AI algorithm. As a result of the discussion, patients will either be determined to be appropriate for immediate invasive strategy versus watchful waiting depending on whether high-risk PE criteria are met. For those in the intermediate-high risk category, there remains ambiguity on timing and appropriateness of invasive intervention. On day 1 of admission, patients will undergo a walking test evaluating for abnormalities in heart rate, heart rate recovery, and oxygen need. If criteria is met, patients will be randomized in a 2:1 fashion (treatment versus control) to evaluate use of early-invasive strategy.
Sponsors
Inari Medical
University Hospitals Cleveland Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients obtaining a CT at University Hospitals found to have a pulmonary embolism with evidence of right ventricular strain (RV:LV \> 0.9) along with an abnormal vital sign (HR \> 110 bpm, RR \> 30/min, SBP \< 100 mmHg, or O2 saturation \< 90%) * Patients undergoing PERT discussion as deemed appropriate by the provider
Exclusion criteria
* Age \<18 * Pregnant patients. Women of childbearing age will be asked if they are pregnant before enrollment. No formal pregnancy test will be performed as a part of this study. If a patient does require invasive intervention, as part of the routine procedure for cardiac catheterization laboratory, women of childbearing age will either undergo pregnancy testing or opt-out per their own discretion * Patients unable to perform 6MWT (e.g., lack of one or both legs) will not be included in the randomization. They will be included in the observation for routine treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time-to-activation | 3 days | Activation of PERT from time of CT scan to call; compared to historical control |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of stay | 30 days | Total length of hospital stay |
| 6-minute walk test (6MWT) | 6 minutes | The distance (meter) and walking speed (meter per seconds) in a 6-minute walk test. |
| Change in quality of life as measured by PEmb QoL | Baseline, 30 days, 90 days | PEmb-QoL summary score (0-100, higher score indicate worse outcome) |
Countries
United States
Outcome results
None listed