76 Participants Needed

VentilO App for Mechanical Ventilation Complications

(VentilO Trial)

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Laval University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the treatment VentilO 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 preventing lung injury, which may indirectly support the effectiveness of VentilO if it incorporates similar features.12345

How is the VentilO treatment different from other treatments for mechanical ventilation complications?

The VentilO treatment is unique because it uses a digital app to manage mechanical ventilation complications, offering features like virtual home visits, customizable care plans, and secure communication, which are not typically part of standard treatments for these complications.16789

What is the purpose of this trial?

This is a randomized, open-label study comparing intial settings made by clinicians with settings recommandation made by the VentilO application immediately after intensive care unit admission.The study will allow direct comparison of the frequency of acidosis when patients are ventilated using the parameters of the VentilO application versus parameters chosen by the clinician. The variables determined by the clinician or VentilO will be respiratory rate, tidal volume and resulting minute ventilation.

Eligibility Criteria

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 was put on a breathing machine right after heart surgery and taken to intensive care.
I am over 18 years old.
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

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: CliniciansExperimental Treatment1 Intervention
Clinicians include respiratory therapists, physcians, medical students
Group II: VentilOActive Control1 Intervention
VentilO, smartphone application (or web plateform)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Laval University

Lead Sponsor

Trials
439
Recruited
178,000+

Findings from Research

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.
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]
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.
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.
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]

References

Peak Pressures and PaO2/FiO2 Ratios Are Associated With Adverse Outcomes in Patients on Mechanical Ventilators. [2018]
Limiting ventilator-induced lung injury through individual electronic medical record surveillance. [2010]
Clinical Impact of an Electronic Dashboard and Alert System for Sedation Minimization and Ventilator Liberation: A Before-After Study. [2022]
A multicenter mortality prediction model for patients receiving prolonged mechanical ventilation. [2022]
Establishment of a prospective cohort of mechanically ventilated patients in five intensive care units in Lima, Peru: protocol and organisational characteristics of participating centres. [2019]
Real-Time, Automated Detection of Ventilator-Associated Events: Avoiding Missed Detections, Misclassifications, and False Detections Due to Human Error. [2019]
Adaptive support ventilation. [2019]
The Transitions to Long-term In Home Ventilator Engagement Study (Transitions to LIVE): study protocol for a pragmatic randomized controlled trial. [2022]
Complications of long-term mechanical ventilation. [2019]
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