ProVent-14 Score for Patients on Mechanical Ventilation

Recruiting at 2 trial locations

Overseen By Jared Greenberg, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Rush University Medical Center

Disqualifiers: Neuromuscular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

238 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the usefulness of the ProVent-14 score in predicting long-term outcomes for patients on a ventilator for at least 14 days. The ProVent-14 score uses specific health details to estimate the risk of death within a year. The study compares two groups: one uses the ProVent-14 score for predictions, while the other relies on usual methods. Ideal participants are ICU staff directly caring for patients on a ventilator for 14-16 days, excluding those with conditions like ALS.

As an unphased study, this trial provides a unique opportunity to contribute to research that could enhance patient care and outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the ProVent-14 score is safe for use in predicting long-term outcomes for mechanically ventilated patients?

Research shows that the ProVent-14 score predicts the risk of death within a year for patients on a ventilator for 14 days. This score is not a drug or treatment, so it poses no safety concerns. Instead, it uses patient information to help doctors make predictions.

Past studies have tested the ProVent-14 score in various settings and found it effective. It helps doctors estimate a patient's chance of surviving after a year. As a decision-making tool, it does not cause side effects or require safety testing like a new drug.

Overall, the ProVent-14 score improves the accuracy of doctors' predictions about patient outcomes. There are no known risks or side effects because it is not a physical treatment but a method for assessing patient prognosis. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ProVent-14 score because it offers a new way to predict outcomes for patients on mechanical ventilation. Unlike the usual prognostic approach, which relies heavily on a clinician's experience and general guidelines, the ProVent-14 score provides a data-driven method to assess patient prognosis. This score integrates specific clinical factors to give a clear picture of a patient's likely trajectory, which could lead to more personalized care decisions. By offering a more objective and standardized assessment tool, it has the potential to improve decision-making and patient outcomes in critical care settings.

What evidence suggests that the ProVent-14 score is effective for predicting long-term outcomes in mechanically ventilated patients?

Research has shown that the ProVent-14 score reliably predicts the risk of death within one year for patients on a ventilator for at least 14 days. Studies indicate that this score can estimate death risk, with rates ranging from 7% to 75% based on the score level. It uses clinical data to help doctors make informed predictions about long-term outcomes. In this trial, participants will either use their usual prognostic approach or be guided by the ProVent-14 score to form a prognosis. Multiple studies have proven the ProVent-14 score accurate, suggesting it could be a valuable aid in making critical care decisions. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for ICU day-shift clinicians (attending physicians, fellow physicians, advanced practice providers, or nurses) who are caring for patients needing mechanical ventilation 14-16 days after intubation and not transitioning to comfort-focused care.

Inclusion Criteria

I am a healthcare provider for a patient needing a ventilator 14-16 days after intubation, not transitioning to comfort care.

Exclusion Criteria

N/A

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prognostic Assessment

ICU clinicians assess patients using either their usual prognostic approach or the ProVent-14 score to predict one-year mortality

14 days

In-hospital assessment

Follow-up

Participants are monitored for accuracy of mortality predictions and other secondary outcomes

1 year

What Are the Treatments Tested in This Trial?

Interventions

• ProVent-14 score

Trial Overview The study tests if ICU clinicians make more accurate one-year mortality predictions when they know a patient's ProVent-14 score—a simple tool that estimates death risk based on conditions at day 14 of mechanical ventilation.

How Is the Trial Designed?

Group I: ProVent-14 Guided Prognostic Approach Experimental Treatment 1 Intervention

Participants will be asked to form a prognosis after being provided the patient's ProVent-14 score and its meaning

Group II: Usual Prognostic Approach Active Control 1 Intervention

Participants will make form a prognosis using their usual approach

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

University of North Carolina, Chapel Hill

Collaborator

Trials

1,588

Recruited

4,364,000+

Published Research Related to This Trial

The modified ProVent score effectively predicts 1-year mortality in patients requiring prolonged mechanical ventilation, with a study involving 398 patients showing a 51% mortality rate for those on ventilation for 21+ days and 32% for 14-20 days.

The model demonstrated strong accuracy and generalizability, with no significant difference between predicted and observed mortality rates, indicating it could be a reliable tool for identifying high-risk patients after 14 days of mechanical ventilation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation and Extension of the Prolonged Mechanical Ventilation Prognostic Model (ProVent) Score for Predicting 1-Year Mortality after Prolonged Mechanical Ventilation. Udeh, CI., Hadder, B., Udeh, BL.[2019]

The Prognosis for Prolonged Ventilation (ProVent) score is a useful tool for predicting ICU mortality in chronically critically ill patients, with mortality rates increasing significantly from 25% for a score of 0 to 84% for a score of 4 or higher, based on a study of 1360 ICU patients.

The ProVent score can be effectively applied earlier in the course of prolonged mechanical ventilation (after 14 days), providing consistent prognostic information for patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mortality in chronically critically ill patients: Expanding the use of the ProVent score. Boniatti, MM., Giustina, AD., Marin, LG., et al.[2018]

The study validated the Prolonged Mechanical Ventilation Prognostic Model (ProVent) in 1288 medically ill patients requiring at least 14 days of mechanical ventilation, finding a high 1-year mortality rate of around 79% for both groups studied.

An extended version of the ProVent model, which incorporates co-morbidities and laboratory data, significantly improved the prediction accuracy of 1-year mortality, with an area under the curve increasing from 0.69 to 0.89.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modification of the prolonged mechanical ventilation prognostic model score to predict short-term and 1-year mortalities. Park, YR., Lee, JS., Kim, HJ., et al.[2020]

The ProVent 14 score effectively predicts 1-year mortality risk in patients requiring prolonged mechanical ventilation, with a significant correlation between higher scores and increased mortality rates (up to 75% for scores ≥4).

In a study of 366 patients, the ProVent 14 score demonstrated good discrimination ability with an area under the receiver operating characteristic curve of 0.74, indicating its potential utility in clinical settings for assessing patient prognosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of the Prognosis for Prolonged Ventilation (ProVent) score in patients receiving 14days of mechanical ventilation. Kim, WY., Jo, EJ., Eom, JS., et al.[2019]

The ProVent score effectively predicts one-year mortality in patients requiring prolonged mechanical ventilation, demonstrating a one-year mortality rate that increases significantly with higher ProVent scores (from 21% to 94%).

In a study of 201 patients in French community ICUs, the ProVent score maintained a good predictive ability with an area under the curve (AUC) of 0.74, indicating its potential utility outside of the original development centers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-year mortality in patients requiring prolonged mechanical ventilation: multicenter evaluation of the ProVent score. Leroy, G., Devos, P., Lambiotte, F., et al.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29202432/

Validation of the Prognosis for Prolonged Ventilation ... Overall mortality at 1year was 43%. For ProVent 14 scores ranging from 0 to ≥4, 1-year mortality rates were 7%, 22%, 41%, 52%, and 75%, respectively (log-rank ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26418231/

Validation and Extension of the Prolonged Mechanical ... The Prolonged Mechanical Ventilation Prognostic model (ProVent) score was developed to predict 1-year mortality in these patients.

3. qxmd.com qxmd.com/calculate/calculator_739/provent-14-score-for-prolonged-mechanical-ventilation

ProVent 14 score for prolonged mechanical ventilation Determine risk of 1-year mortality after prolonged mechanical ventilation.

4. researchgate.net researchgate.net/publication/321273695_Validation_of_the_Prognosis_for_Prolonged_Ventilation_ProVent_score_in_patients_receiving_14_days_of_mechanical_ventilation

Validation of the Prognosis for Prolonged Ventilation ... For ProVent 14 scores ranging from 0 to ≥ 4, 1-year mortality rates were 7%, 22%, 41%, 52%, and 75%, respectively (log-rank test, P < 0.001). The area under the ...

5. aacnjournals.org aacnjournals.org/ajcconline/article/27/6/477/4121/Score-for-Predicting-Ventilator-Weaning-Duration

Score for Predicting Ventilator Weaning Duration in Patients ... A score derived from ventilator settings may help clinicians predict the timing of ventilator liberation in patients requiring prolonged mechanical ventilation.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4788381/

Development and Validation of a Mortality Prediction Model ... The PnoVent 14 Score is calculated by summing the point values assigned according to the presence of risk variables listed in Table 3 when measured on day 14 of ...

7. bmjopen.bmj.com bmjopen.bmj.com/content/12/9/e066197

External validation of the ProVent score for prognostication ... Results 380 patients (49%) had died after 1 year. One-year mortality for ProVent scores from 0 to 5 were: 15%, 27%, 57%, 66%, 72% and 76% ...

8. atsjournals.org atsjournals.org/doi/pdf/10.1513/AnnalsATS.201504-200OC

ORIGINAL RESEARCH The. Prolonged Mechanical Ventilation Prognostic model (ProVent) score was developed to predict 1-year mortality in these patients. External ...