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Advisory Lead ARDS Respirator Management

Advisory Lead ARDS Respirator Management

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04274296
Acronym
ALARM
Enrollment
472
Registered
2020-02-18
Start date
2020-09-01
Completion date
2023-01-11
Last updated
2023-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ARDS, Human

Brief summary

A advisory will be activated in the ICUs patient data management system. The trial will be conducted as observational cohort trial. During the first six month all patients with a LIPS ≥ 4 will be included in the control group. No change of care is needed. In a second phase during the next six months, all patients with a LIPS ≥ 4 will be included into the advisory group where advisories will be shown in the patient data management system. To create this advisory, a clinical advisory rule is executed every 4 hours and the appropriate advisory text is calculated. If the defined threshold values (driving pressure ≥ 15mbar) are reached, then the advisory displays a recommendation to rethink the patient's ventilation strategy. Furthermore, permissive hypercapnia and oxygen saturating limits considered as safe will be given. (paCO2: 55mmHg, pH: 7.25, paO2: 80 mmHg, SaO2: 92%)

Detailed description

Background Lung protective ventilation is a well-established treatment to reduce ventilator-induced lung injury (VILI) in patients suffering from ARDS. To quantify lung protective ventilation the concept of driving pressure (ΔP) and mechanical power were postulated. Although low tidal volumes and low driving pressures are considered standard of care, it was shown that lung protective ventilation is very little used in ICU patients. Especially in those with a less severe lung disease. Automated Clinical Decision Support (CDS) systems are gaining more attention in clinical practice. They have been successfully used to increase medical provider adherence to guidelines or local department policy. Another successful means of influencing behavior of medical providers are so called nudge-based interventions. Currently there is little evidence on nudge-type interventions or automated alerts for ventilator settings in the ICU. To our knowledge studies that linked these interventions to a change in patient's outcome are lacking. Hypothesis Activation of an advisory in the patient data management system accompanied by educational sessions and feedback emails decrease ventilation driving pressure in mechanically ventilated patients at increased risk of ARDS (LIPS ≥ 4). As secondary outcome parameters, incidence of ARDS, ventilator free days, reintubation rate, length of stay in the ICU or the hospital and mortality at day 28 will be evaluated. Methods As an advisory is activated in the ICU software, medical staff caring for the patients can't be blinded. Therefore, the trial will be conducted as observational cohort trial. During the first six month all patients with a LIPS ≥ 4 will be included in the control group. No change of care is needed. In a second phase during the next six months, all patients with a LIPS ≥ 4 will be included into the alert group where advisories will be shown in the patient data management system. To create this advisory, a clinical advisory rule is executed every 4 hours and the appropriate advisory text is calculated. If the defined threshold values (driving pressure ≥ 15mbar) are reached, then the advisory displays a recommendation to rethink the patient's ventilation strategy. Furthermore, permissive hypercapnia and oxygen saturating limits considered as safe will be given. (paCO2: 55mmHg, pH: 7.25, paO2: 80 mmHg, SaO2: 92%) Outcome The primary outcome is an improvement of medical stuff's adherence to current recommendations shown by a reduction of the mean ventilator driving pressure (by using the AUC of driving pressures). The secondary outcomes are ventilator free days, 28-day mortality, reintubation rate, incidence of ARDS and length of stay in the ICU and the hospital.

Interventions

DEVICEActivation of Advisory

Advisory is activated which will show if driving pressure is greater or equal 15

Sponsors

Philips Austria GmbH
CollaboratorUNKNOWN
Medical University of Vienna
CollaboratorOTHER
Mathias Maleczek
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

Inclusion criteria

* LIPS \>= 4, ventilated invasively at point of screening

Exclusion criteria

* ARDS at admission * Pregnant patients * Age \< 18 years * Patients with elevated intracranial pressure

Design outcomes

Primary

MeasureTime frameDescription
Change of AUC of driving pressure10 daysThe driving pressure will be used to create a graph; The AUC will be calculated for each patient. Changes in AUC will be used as measurement for driving pressure over time.

Secondary

MeasureTime frame
Change in ventilator free daysDay 1-28
28-day mortality, 90-day mortality and one-year mortality1 Year
Change in ARDS incidenceDay 1-28
Reintubation rate due to respiratory failureDay 1-28
Reduction of mechanical powerDay 1-10

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026