Harmonized and Pooled Database, Named PRIME.

NCT06592937 | Completed

• 1 other identifier: PRIME-NEU
• Study Type: observational
• Target: 3,270
• Locations: 1 country
• Sites: 1

Brief Summary

We merged the dataset of three large observational studies of invasive ventilation in critically ill patients.

Conditions

Invasive Ventilation

Keywords

ICU; Invasive ventilation; Respiratory support; Mortality

Outcome Measures

Primary Outcomes (1)

• ICU morality

  any mortality occurred during ICU stay

  ICU stay, anticipated average 15 days

Secondary Outcomes (1)

• Mechanical Power

  During the first 7 days of invasive ventilation

Study Arms (1)

Patients receiving invasive ventilation

Patients receiving invasive ventilation, included in PRoVENT, PRoVENT-iMiC, and ENIO

Other: Invasive ventilation

Interventions

Invasive ventilation OTHER

Invasive ventilation and respiratory support

Patients receiving invasive ventilation

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

PROVENT, PROVENT-iMiC and ENIO included various types of patients, receiving ventilation for different reasons. For this first analysis we will select patients receiving invasive ventilation for acute brain injury.

All patients in the PRIME database are eligible for participation in the initial analysis presented here. We will exclude patients receiving ventilation fir another reason than acute brain injury.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Amsterdam, Netherlands

Location

MeSH Terms

Interventions

Noninvasive Ventilation

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Marcus J Schultz, Prof

  Amsterdam UMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: September 19, 2024
• Study Start: January 1, 2024
• Primary Completion: July 26, 2024
• Study Completion: July 26, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: After our first pubblication (next six months) and they will remain available for ever
• Access Criteria: For this, interested investigators will have to provide a detailed analysis plan, containing a testable hypothesis, clearly described endpoints and an analysis plan. After approval, investigators will be provided with a mock database that will allow them to write an analysis script in R. PROVE network investigators will then run the script on the PRIME database and provide the investigators with the results. Any publication from an additional analysis must follow the rules for publication denoted by the PROVE network

Locations

NL (1)