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

Trial Summary

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 data supports the effectiveness of the ProVent-14 Score treatment for patients on mechanical ventilation?

The ProVent-14 Score is a tool used to predict the likelihood of survival for patients who need long-term help from a machine to breathe. Studies have shown that it can help doctors estimate the chances of a patient surviving for a year, which can guide treatment decisions. ^{1 2 3 4 5}

Is the ProVent-14 score safe for use in humans?

The ProVent-14 score is a tool used to predict outcomes for patients on prolonged mechanical ventilation, but there is no specific safety data about its use as it is not a treatment or medication. ^{1 2 3 4 5}

How does the ProVent-14 Score treatment differ from other treatments for patients on mechanical ventilation?

The ProVent-14 Score is unique because it is a prognostic tool used to predict the likelihood of survival for patients on prolonged mechanical ventilation, rather than a direct treatment. It helps healthcare providers make informed decisions about patient care by assessing long-term outcomes, which is different from standard treatments that focus on immediate medical interventions. ^{1 2 3 4 5}

What is the purpose of this trial?

One challenge with decision making for mechanically ventilated is that their prognosis is often uncertain. The ProVent-14 score incorporates clinical variables measured on the 14th day of mechanical ventilation to predict risk of death in one year. The ProVent-14 is easy to calculate has been externally validated. However, it is unclear how often clinicians use the ProVent-14 score to predict long-term outcomes for patients requiring 14 days of mechanical ventilation or if it helps clinicians make more accurate predictions. The purpose of this study is to determine whether ICU clinicians who receive a patient's ProVent-14 score make more accurate predictions for mortality at one year than ICU clinicians who do not.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Modification of the prolonged mechanical ventilation prognostic model score to predict short-term and 1-year mortalities. [2020]

2. United States 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. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Mortality in chronically critically ill patients: Expanding the use of the ProVent score. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Validation of the Prognosis for Prolonged Ventilation (ProVent) score in patients receiving 14days of mechanical ventilation. [2019]

5. England pubmed.ncbi.nlm.nih.gov

One-year mortality in patients requiring prolonged mechanical ventilation: multicenter evaluation of the ProVent score. [2021]