PRactice of Ventilation and Adjunctive Therapies in COVID... | NCT05954351

Studies
PRactice of Ventilation and Adjunctive Therapies in COVID-19 Patients.

NCT05954351

Sponsor

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

Status

Completed

Last Update Posted

Jul 3, 2024Actual

Enrollment

2,465Actual

Phase

Not provided

Conditions

COVID-19 Acute Respiratory Distress Syndrome

Interventions

Not provided

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2022Actual

Primary Completion Date

Jul 1, 2023Actual

Completion Date

Jul 1, 2023Actual

First Submitted Date

Jul 19, 2023

First Submission Date that Met QC Criteria

Jul 19, 2023

First Posted Date

Jul 20, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 1, 2024

Last Update Posted Date

Jul 3, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof. Dr. Marcus J. Schultz, Professor Dr. Marcus J. Schultz, Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)Principal Investigator

Lead Sponsor

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

Collaborators

Name	Class
ZonMw: The Netherlands Organisation for Health Research and Development	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

PRactice of Ventilation and Adjunctive Therapies in COVID-19 Patients. An observational study of ventilation practice and adjunctive therapies in critically ill, invasively ventilated COVID-19 patients during the first and second surge of COVID-19 in the Netherlands.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,465Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ICU mortality		90 days from inclusion

Secondary Outcomes

Measure	Description	Time Frame
Duration of ventilation		90 days from inclusion
28-day ventilator free days		90 days from inclusion
28-day, 90-day mortality

Other Outcomes

Measure	Description	Time Frame
Acute kidney injury		90 days from inclusion
duration of ventilation in survivors		90 days from inclusion
use of muscle paralysis

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

receiving invasive ventilation or high-flow nasal oxygen for COVID-19 for SARS-CoV-2
admitted to one of the ICUs of the participating hospitals

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

120 Years

Standard Ages

AdultOlder Adult

Study Population

invasively ventilation COVID-19 patients, admitted between March 1 to June 1, 2020, and October 1 to December 31, 2020, to one of the 22 participating ICU's in the Netherlands.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Academic Medical Center		Amsterdam	North Holland	1105 AZ	Netherlands

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided