Effect of Automated Closed-Loop Ventilation Versus Conventional Ventilation on Duration and Quality of Ventilation

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    1200
  • sponsor
    Prof. Dr. Marcus J. Schultz
Updated on 25 January 2021

Summary

INTELLiVENT-Adaptive Support Ventilation (ASV) is a fully automated closed-loop mode of mechanical ventilation available on commercial ventilators. Evidence for clinical benefit of INTELLiVENT-ASV in comparison to non-automated ventilation is lacking.

The ACTiVE study is an international, multicenter, randomized controlled trial in invasively ventilated ICU patients with the objective to compare INTELLiVENT-ASV to conventional ventilation. We hypothesise that INTELLiVENT-ASV shortens the duration of ventilation and improves the quality of breathing.

Description

Objective

The primary objective of this trial is to compare INTELLiVENT-ASV with non-automated ventilation in critically ill intensive care unit (ICU) patients with respect to ventilation duration and quality of breathing.

Study design

International, multicenter, superiority randomized clinical trial in critically ill, intubated and ventilated adult ICU patients with an anticipated duration of ventilation of at least 24 hours.

Study population

Adult patients admitted to ICUs in the Netherlands and Italy.

Sample size calculation

The sample size is based on the hypothesis that INTELLiVENT-ASV will shorten ventilation duration by 1.5 days with no changes in mortality rate. Based on previously performed studies a sample of 1,200 patients (600 in each treatment group) is needed to have beta of 80% power and a two-tailed alpha of 0.05, to detect a mean between-group difference of 1.5 VFD-28, allowing a dropout rate of 5%. By including 1,200 patients, this study will be sufficiently powered to detect differences in the co-primary endpoint, which is quality of breathing.

Methods

Within one hour of start of ventilation in the ICU, patients are randomly assigned in a 1:1 ratio to INTELLiVENT-ASV or non-automated ventilation. Randomization will be stratified by center. As soon as possible after randomization, but within a maximum of 72 hours, deferred consent is obtained from the legal representative of the patient.

INTELLiVENT-ASV In patients who are randomized to INTELLiVENT-ASV, the ventilator is switched to this fully automated mode as soon possible. The sensors for end-tidal carbon dioxide (ETCO2) and pulse oximetry (SpO2) are connected and activated in the ventilator. Patient's gender and height are set on the ventilator and patient condition is chosen if applicable. If needed, the targets zones for ETCO2 and SpO2 are adjusted. The default alarm limits are accepted.

It is advised to enable QuickWean in all patients. The use of the automated Spontaneous Breathing Trial (SBT) function is left to the discretion of the clinician. Each SBT result will be used to check for extubation readiness.

CONVENTIONAL VENTILATION Patients who are randomized to conventional ventilation will be ventilated with a mode that is not fully automated, thus standard volume controlled (VCV) or pressure controlled ventilation (PCV), and pressure support ventilation (PSV), depending on patient's activity. None of the following semi or fully automated modes of ventilation is allowed at any time: Neurally Adjusted Ventilatory Assist (NAVA), SmartCare/PS or Proportional Assist Ventilation (PAV).

In all patients who receive assist ventilation (i.e., VCV or PCV), three times a day it should be checked whether the patient can accept supported ventilation (i.e., PSV); this should also be tried when the patient shows respiratory muscle activity during assist ventilation, or in case of patient-ventilator asynchrony.

Patients can be subjected to SBTs using either a T-piece or ventilation with minimal support (pressure support level < 10 cm H2O). An SBT is deemed successful when the following criteria are met for at least 30 minutes, i.e., respiratory rate < 35/min, peripheral oxygen saturation > 90%, increase < 20% of heart rate and blood pressure, and no signs of anxiety and diaphoresis. Each SBT result will be used to check for extubation readiness.

In both groups patients are extubated if standard extubation criteria are fulfilled, i.e., normal body temperature, patient awake and responsive/cooperative, adequate cough reflex, adequate oxygenation and hemodynamically stable.

Details
Condition Ventilator-free Days, Quality of Breathing, Ventilator-free Days, Ventilator-free Days
Treatment INTELLiVENT-ASV, Conventional ventilation
Clinical Study IdentifierNCT04593810
SponsorProf. Dr. Marcus J. Schultz
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

admission to one of the participating ICUs
intubated and receiving invasive ventilation
anticipated duration of ventilation of at least 24 hours

Exclusion Criteria

age below 18 years
patients with suspected or confirmed pregnancy
invasive ventilation > 1 hour in the ICU
invasive ventilation > 6 hours in the operating room or emergency department directly preceding the current ICU admission
participation in another interventional trial using similar endpoints
after recent pneumectomy or lobectomy
morbid obesity (body mass index > 40 kg/m2)
premorbid restrictive pulmonary disease (evidence of chronic interstitial infiltration on chest radiographs)
unreliable pulse oximetry, e.g., patients with carbon monoxide poisoning
any neurologic diagnosis that can prolong duration of mechanical ventilation, e.g., Guillain-Barr syndrome, high spinal cord lesion or amyotrophic lateral sclerosis, multiple sclerosis, or myasthenia gravis
patients receiving or planned to receive veno-venous, veno-arterial or arterio-venous extracorporeal membrane oxygenation (ECMO)
previous randomized in this study
no informed consent
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