Harmonized and Pooled Database, Named PRIME.

Completed

• Conditions: Invasive Ventilation
• Interventions: Other: Invasive ventilation

• Registration Number: NCT06592937
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary

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

Detailed Description

PRIME contains the individual patient data of 3 large observational studies of ventilation, 'PRactice of VENTilation in critically ill patients without ARDS' (PRoVENT), 'PRactice of VENTilation in critically ill patients in Middle-income Countries' (PRoVENT-iMiC) and 'Extubation strategies and in neuro-intensive care unit patients and associations with outcomes' (ENIO).

Study Timeline

• Study Start: 2024-01-01
• Study First Submitted: 2024-07-22
• Primary Completion: 2024-07-26
• Study Completion: 2024-07-26
• Status Verified: 2024-09
• Study First Submitted QC: 2024-09-10
• Last Update Submitted: 2024-09-10
• Study First Posted: 2024-09-12
• Last Update Posted: 2024-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3270

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients receiving invasive ventilation	Invasive ventilation	Patients receiving invasive ventilation, included in PRoVENT, PRoVENT-iMiC, and ENIO

Primary Outcome Measures

Name	Time	Method
ICU morality	ICU stay, anticipated average 15 days	any mortality occurred during ICU stay

Secondary Outcome Measures

Name	Time	Method
Mechanical Power	During the first 7 days of invasive ventilation	All variables or parameters recorded from the ventilator, when the patient is under mechanical ventilation, to calculate the mechanical power (calculated in Joule/minute)

Trial Locations

Locations (1)

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA); 🇳🇱 Amsterdam, Netherlands