Advisory Lead ARDS Respirator Management

NCT04274296 | Completed FDA Device

• 1 other identifier: ALARM
• Study Type: observational
• Target: 472
• Locations: 1 country
• Sites: 1

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%)

Conditions

ARDS, Human

Outcome Measures

Primary Outcomes (1)

• Change of AUC of driving pressure

  The 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.

  10 days

Secondary Outcomes (5)

• Change in ventilator free days

  Day 1-28

• 28-day mortality, 90-day mortality and one-year mortality

  1 Year

• Change in ARDS incidence

  Day 1-28

• Reintubation rate due to respiratory failure

  Day 1-28

• Reduction of mechanical power

  Day 1-10

Study Arms (2)

Control

Control-cohort in which no change in care is needed

Advisory

Cohort in which advisory is activated

Device: Activation of Advisory

Interventions

Activation of Advisory DEVICE

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

Advisory

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients at risk of ARDS at six intensive care units will be included in this trial. Study population will consist of medical and surgical ICU patients.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mathias Maleczek: lead
• Philips Austria GmbH: collaborator
• Medical University of Vienna: collaborator

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Registrar

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: February 18, 2020
• Study Start: September 1, 2020
• Primary Completion: March 28, 2022
• Study Completion: January 11, 2023
• Last Updated: October 19, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)