NCT05260853

Brief Summary

Early prediction and prevention of prolonged weaning in high risk patients via identification through a computer model and additional assistance in treatment through certified weaning centers in Baden-Württemberg

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
7 months until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

March 2, 2022

Status Verified

February 1, 2022

Enrollment Period

1.9 years

First QC Date

July 1, 2021

Last Update Submit

February 18, 2022

Conditions

Invasive VentilationWeaning

Outcome Measures

Primary Outcomes (1)

  • successful weaning

    number of high-risk patients successfully weaned off of invasive ventilation before hospital discharge

    during inpatient stay - maximum 6 months

Study Arms (2)

Intervention

EXPERIMENTAL

High-risk patients as identified by the computer model. Treating staff are supported by specialised staff from the local certified weaning-center

Other: Weaning Board

Control

NO INTERVENTION

clinical date gathered from AOK BW insured patients on invasive ventilation outside the participating centers

Interventions

Weaning BoardOTHER

structured care concept

Also known as: Weaning Consil
Intervention

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 96 hours of invasive ventilation,
  • no more than 7 days have passed since the patient completed their 96th hour of invasive venti-lation,
  • ≥ 30 years old,
  • ≥ 1 comorbidity and/or acute Covid-19 pneumonia
  • not suffering from any neuromuscular disease without weaning potential.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thoraxklinik Heidelberg gGmbH

Heidelberg, 69120, Germany

RECRUITING

Related Publications (4)

  • Trudzinski FC, Neetz B, Dahlhoff J, Hoger P, Kempa A, Neurohr C, Schneider A, Herth FJF, Joves B, Szecsenyi J, Biehler E, Fleischhauer T, Schubert-Haack J, Grobe T, Frerk T; PRiVENT-Study Group. Sex-specific differences in risk factors and outcomes for long-term mechanical ventilation: a longitudinal cohort analysis of claims data. Sci Rep. 2025 Oct 8;15(1):35051. doi: 10.1038/s41598-025-22399-z.

    PMID: 41062742DERIVED

  • Michels-Zetsche JD, Schubert-Haack J, Tanck K, Neetz B, Iberl G, Muller M, Kempa A, Joves B, Rheinhold A, Ghiani A, Tsitouras K, Schneider A, Rauch C, Gehrig P, Biehler E, Fleischauer T, Britsch S, Frerk T, Szecsenyi J, Herth FJF, Trudzinski FC; PRiVENT-Study Group. E-learning-an interventional element of the PRiVENT project to improve weaning expertise. BMC Med Educ. 2024 Apr 19;24(1):420. doi: 10.1186/s12909-024-05416-z.

    PMID: 38641835DERIVED

  • Trudzinski FC, Michels-Zetsche JD, Neetz B, Meis J, Muller M, Kempa A, Neurohr C, Schneider A, Herth FJF, Szecsenyi J, Biehler E, Fleischauer T, Wensing M, Britsch S, Schubert-Haack J, Grobe T, Frerk T; PRiVENT-study group. Risk factors for long-term invasive mechanical ventilation: a longitudinal study using German health claims data. Respir Res. 2024 Jan 27;25(1):60. doi: 10.1186/s12931-024-02693-6.

    PMID: 38281006DERIVED

  • Michels JD, Meis J, Sturm N, Bornitz F, von Schumann S, Weis A, Neetz B, Bentner M, Forstner J, Litke N, Wensing M, Erdmann S, Grobe T, Frerk T, Kempa A, Neurohr C, Schneider A, Muller M, Herth FJF, Szecsenyi J, Trudzinski FC; PRiVENT-Study Group. Prevention of invasive ventilation (PRiVENT)-a prospective, mixed-methods interventional, multicentre study with a parallel comparison group: study protocol. BMC Health Serv Res. 2023 Mar 30;23(1):305. doi: 10.1186/s12913-023-09283-0.

    PMID: 36998047DERIVED

Related Links

Central Study Contacts

Beatrice Müller, BA

CONTACT

+496221396beatrice.mueller@med.uni-heidelberg.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. MD, PhD, Dsc

Study Record Dates

First Submitted

July 1, 2021

First Posted

March 2, 2022

Study Start

August 1, 2021

Primary Completion

June 30, 2023

Study Completion

April 30, 2024

Last Updated

March 2, 2022

Record last verified: 2022-02

Locations

DE(1)