VentilO App for Mechanical Ventilation Complications

(VentilO Trial)

Recruiting at 1 trial location

Overseen By Francois Lellouche Principal investigator, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Laval University

Disqualifiers: No anthropometric data, spontaneous cycles, extubated

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 28 days

76 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new app called VentilO, designed to help manage breathing machines for patients who recently underwent heart surgery. The goal is to determine if the app's settings reduce complications such as acidosis, a condition where the body has too much acid. Participants are divided into two groups: one where clinicians set the breathing machine and another where the VentilO app sets it. Candidates may qualify if they have recently had heart surgery and are using a breathing machine in a controlled mode while in intensive care. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance post-surgery care for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the VentilO application is safe for use in mechanical ventilation settings?

Research shows that the VentilO app helps manage mechanical ventilators, which assist with breathing. It aids in setting up and adjusting these machines for patients. The app involves no drugs or physical procedures, providing ventilation setting recommendations based on each patient's needs.

As a digital tool, VentilO does not carry the same risks as new drugs or medical devices. No reports indicate physical side effects from using the app itself. However, correct use of the app's recommendations is crucial for patient safety.

When used properly, the app can help prevent issues like acidosis, where the body has too much acid, by offering personalized ventilation advice. This makes treatment more precise and tailored to each patient.

Overall, the app is generally well-received as a software tool, with no direct negative effects linked to its use. Medical professionals using VentilO must be trained and know how to integrate its advice with their clinical judgment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the VentilO app because it offers a new way to manage complications from mechanical ventilation. Unlike traditional methods that rely heavily on physical monitoring and adjustments by healthcare professionals, VentilO provides a digital platform that can potentially streamline the management process. It enables clinicians, including respiratory therapists and physicians, to access real-time data and insights, which could lead to more precise and timely interventions. This digital approach promises to enhance patient care by improving decision-making speed and accuracy, which is a significant advantage over existing manual techniques.

What evidence suggests that the VentilO app is effective for reducing mechanical ventilation complications?

Research has shown that electronic tools like the VentilO app, studied in this trial, can enhance patient care during the use of breathing machines. The app employs smart technology to recommend optimal settings for these machines, potentially preventing issues such as acidosis, a condition where the body has excess acid. VentilO considers personal details like gender, height, weight, and body temperature to tailor the settings for each patient. Early results suggest that this technology improves the management of breathing machines by making precise adjustments that humans might overlook. This could result in fewer complications and improved overall care for patients in the intensive care unit. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are intubated and admitted to intensive care right after cardiac surgery, needing controlled ventilation. It's not for patients without height and weight data on file, those breathing mostly on their own upon ICU arrival, or if they're extubated when they get to the ICU.

Inclusion Criteria

I am over 18 years old.

I was put on a breathing machine right after heart surgery and taken to intensive care.

I am on a ventilator in a controlled mode.

Exclusion Criteria

Absence of anthropometric data (height and weight) of patients available in the patient file

Respiratory cycles mainly spontaneous on arrival

I was not on a breathing machine when I arrived in the ICU.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are randomized to receive ventilation settings either from clinicians or the VentilO application immediately after ICU admission

Up to 28 days

Continuous monitoring in ICU

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of respiratory acidosis and other complications

Up to 28 days

What Are the Treatments Tested in This Trial?

Interventions

• VentilO

Trial Overview The study compares initial ventilator settings made by clinicians versus recommendations from the VentilO app immediately after ICU admission. It focuses on how often acidosis occurs with each method by adjusting respiratory rate, tidal volume, and minute ventilation.

How Is the Trial Designed?

Group I: Clinicians Experimental Treatment 1 Intervention

Clinicians include respiratory therapists, physcians, medical students

Group II: VentilO Active Control 1 Intervention

VentilO, smartphone application (or web plateform)

Who Is Running the Clinical Trial?

Laval University

Lead Sponsor

Trials

439

Recruited

178,000+

Published Research Related to This Trial

An electronic algorithm was developed to monitor ventilator settings in real-time, alerting healthcare providers to potentially harmful settings, which was tested on 1,159 patients in intensive care units.

After implementing the alert system, the average exposure to potentially injurious ventilation settings significantly decreased from 40.6 hours to 26.9 hours, indicating improved safety in ventilator care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Limiting ventilator-induced lung injury through individual electronic medical record surveillance. Herasevich, V., Tsapenko, M., Kojicic, M., et al.[2010]

The TtLIVE virtual care solution, designed for patients transitioning to home mechanical ventilation, is being evaluated in a randomized controlled trial with 440 participants to assess its effectiveness compared to usual care, focusing on emergency department visits and caregiver well-being over 12 months.

This study will also analyze healthcare utilization, caregiver burden, and quality of life, while exploring the acceptability of the TtLIVE intervention through qualitative interviews, providing comprehensive insights into both clinical and experiential outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Transitions to Long-term In Home Ventilator Engagement Study (Transitions to LIVE): study protocol for a pragmatic randomized controlled trial. Amin, R., Gershon, A., Buchanan, F., et al.[2022]

Data collected on day 2 of mechanical ventilation, such as the PaO2/FiO2 ratio and peak pressures, can help predict patient outcomes, including the risk of complications and mortality, based on a review of 281 patient episodes.

A low PaO2/FiO2 ratio (<100) is linked to higher mortality, while a higher BMI (>30 kg/m²) is associated with lower mortality, indicating that both respiratory function and body weight are important factors in managing patients on mechanical ventilation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peak Pressures and PaO2/FiO2 Ratios Are Associated With Adverse Outcomes in Patients on Mechanical Ventilators. Whiting, J., Edriss, H., Yang, S., et al.[2018]

Citations

1. withpower.com withpower.com/trial/phase-acidosis-respiratory-4-2025-5bd2a

VentilO App for Mechanical Ventilation Complications The research suggests that electronic tools and algorithms can help improve outcomes for patients on mechanical ventilation by minimizing sedation and ...

2. apps.apple.com apps.apple.com/us/app/ventilo/id1478758927

VentilO - App Store - Apple The VentilO application is a mobile educational application that allows healthcare professionals in charge of patients with mechanical ventilation.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05587686

Potential Impact of the Use of the Application VentilO This educational application provides clinicians with combinations of tidal volume and respiratory rate based on gender, height, weight, body temperature and ...

4. opencriticalcare.org opencriticalcare.org/resources/mechanical-ventilation-app-by-ventilo-2/

Mechanical Ventilation App by Ventilo v2023 The latest version has additional support for mechanical ventilation setting titration based on physiologic characteristics and care goals.

5. researchgate.net researchgate.net/publication/389019492_VENTIlatory_strategies_for_patients_with_severe_traumatic_brain_injury_in_the_LOw-_and_Middle-Income_CountrieS_-_The_VENTILOMICS_survey

VENTIlatory strategies for patients with severe traumatic ... This study revisits the 'VENTILatOry strategies in patients with severe traumatic brain injury' (VENTILO) survey, focusing on ventilatory ...

6. play.google.com play.google.com/store/apps/details?id=com.iucpq.ventillo&hl=en_US

VentilO+ - Apps on Google Play The VentilO application is a mobile educational application that allows healthcare professionals in charge of patients with mechanical ventilation.

7. go.drugbank.com go.drugbank.com/conditions/DBCOND0043767

Mechanical Ventilation Complication (DBCOND0043767) Potential Impact of the Use of the Application VentilO After Cardiac Surgery, No drug interventions, Not Available, Not Available, active_not_recruiting.