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Update on the practice of mechanical ventilation in non-ARDS ICU patients – An international, multi-centre, prospective, observational ICU cohort study of the PROVENet

Update on the practice of mechanical ventilation in non-ARDS ICU patients – An international, multi-centre, prospective, observational ICU cohort study of the PROVENet - PRoVENT 2+

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00033262
Enrollment
1151
Registered
2023-12-28
Start date
2024-02-01
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Mechanical ventilation

Interventions

Group 1: Medical data will be assessed in intervals in patients undergoing mechanical ventilation on intensive care units.

Sponsors

Universitätsklinikum Carl Gustav Carus an der TU Dresden, Klinik und Poliklinik für Anästhesiologie und Intensivtherapie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients admitted to intensive care unit within enrolment window; initiation of high-flow nasal oxygen (HFNO, =30 l/min) or NIV/CPAP with at least 5 cmH2O expiratory pressure or invasive mechanical ventilation within enrolment window

Exclusion criteria

Exclusion criteria: Age <18 years; ventilated patients transferred from another hospital under ongoing invasive or non-invasive ventilation (incl. high flow oxygen therapy (=30l/min)); (Inability to obtain written informed consent for participation and/or data usage, if locally mandated)

Design outcomes

Primary

MeasureTime frame
Proportion of patients ventilated invasively within lung-protective limits, defined as tidal volume of =8 ml/kg predicted body weight and positive end-expiratory pressure of =5 cmH2O (both must be met)

Secondary

MeasureTime frame
• Demographics/Cohort characteristics (incl. medical history as well as reasons for ICU admission and mechanical ventilation); • Disease severity scores, Lung injury prediction score (LIPS), sedation scores; • Ventilator modes and settings; • Vital signs, incl. respiratory variables and haemodynamics; • Proportion of patients at risk for ARDS (LIPS =4 points); • Rate of progression to ARDS; • Incidence of Non-intubated ARDS; • Incidence of missed ARDS diagnosis; • Utilization of adjunctive therapies, i.e. neuro-muscular blockade, prone positioning, extra-corporeal techniques, inhalative NO, etc.; • Utilization of adjunctive diagnostics, i.e. daily chest X-ray, lung ultrasound, electrical impedance tomography, and oesophageal pressure measurement; • Rate of extra-/ pulmonary complications; • ICU Mortality rate, hospital mortality rate, mortality at day 28 and 90; • Length of ICU stay; • Duration of invasive mechanical ventilation; • Ventilator-free and ECMO-free days at day 28 and 90; • ICU- and hospital-free days at day 28 and 90; • Site-level organisational, staffing, and resource information will be collected via a one-time online survey.

Countries

Germany

Contacts

Public ContactMartin Scharffenberg

Universitätsklinikum Carl Gustav Carus an der TU Dresden, Klinik und Poliklinik für Anästhesiologie und Intensivtherapie

martin.scharffenberg@ukdd.de+49 351 458 4110

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026