NCT06157073

Efficacy and Safety of Automated Closed-loop Ventilator vs Conventional Open-loop Ventilator in the Emergency Department

A Randomized, Controlled Trial to Evaluate the Efficacy and Safety of Fully Automated Closed-loop Ventilator Versus Conventional Open-loop Ventilator in Ventilated Patients in the Emergency Department

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: University of Malaya · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients presenting to the emergency department (ED) may require breathing support with machines depending on the condition. Throughout the breathing support, the settings on the breathing machines will be tailored to the patient's requirements. These settings are manually adjusted by trained physicians. Currently, there are machines which can automatically change the settings based on real-time specific information obtained from the patient. This study aims to compare the use of machines which require manual adjustments (open-loop conventional ventilators) and machines which can automatically change the settings (closed-loop automated ventilators). Patients will be carefully selected to ensure no harm is caused whilst delivering the best care. This study will look into the duration when patients are receiving optimum settings and levels of oxygen and carbon dioxide in the blood. The outcomes of this study would allow us to identify methods to improve patient care.

Detailed description

Invasive mechanical ventilation is a lifesaving intervention for patients with respiratory failure in the emergency department (ED). Recent technological advancements have introduced closed-loop automated ventilators as a potential alternative to open-loop conventional ventilators. However, the efficacy and safety of closed-loop automated ventilators in the emergency setting remains understudied. This research aims to evaluate the efficacy and safety of closed-loop automated ventilator compared to open-loop conventional ventilator in intubated and ventilated patients in the ED. A randomized controlled trial will be conducted in an ED of a tertiary university-affiliated hospital. Eligible patients are 18 years or older, decision made by treating physicians to intubate and mechanically ventilate. Some of exclusion criteria are pregnancy, heart failure, metabolic acidosis, circulatory shock, life-threatening asthma and morbid obesity. The primary measure of efficacy is the duration of ventilation within a predefined range of acceptable respiratory parameters between automated and conventional ventilation. Secondary outcome measures are; number of manual adjustments required to attain targeted settings in automated and conventional ventilators, PaO2/FiO2 ratio (PF ratio), arterial blood gas results, vital signs, breath-by-breath analysis, and rate of ventilator dyssynchrony. The ventilator used in the intervention arm is the closed-loop automated ventilator Hamilton C6s INTELLIVENT-ASV (Hamilton Medical AG, Switzerland). Hamilton C1 ASV is chosen as the open-loop conventional comparator as it is similar to Hamilton C6s INTELLIVENT-ASV, without the INTELLIVENT software. Based on Lellouche et al, the calculated total sample size with a dropout rate of 10% is 132. The data is analysed based on the intention-to-treat (ITT) and per-protocol (PP) principles. The primary endpoint measurements are reported as areas under the curves (AUC) within the predefined range of acceptable respiratory parameters. Between-group differences in continuous variables are analysed using independent t-test or Mann-Whitney U test. Between-group differences in categorical variables are analysed using chi-square test.

Conditions

• Ventilator Lung
• Mechanical Ventilation Complication
• Ventilator-Induced Lung Injury
• ARDS

Interventions

Type	Name	Description
DEVICE	Closed-loop ventilator	Fully automated closed-loop ventilator using the INTELLIVENT software
DEVICE	Open-loop ventilator	Conventional closed-loop ventilator with manual adjustments by the physician in charge

Timeline

• Start date: 2024-01-01
• Primary completion: 2024-12-31
• Completion: 2025-12-31
• First posted: 2023-12-05
• Last updated: 2023-12-05