NCT06332768

Brief Summary

The weaning failure is a paramount challenge when aggressive discontinuation of respiratory support in ARDS. The aim of the study is to improve weaning safety and efficacy by a transient postextubation non-invasive respiratory support.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 1, 2017

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

March 20, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 27, 2024

Completed
Last Updated

March 27, 2024

Status Verified

March 1, 2024

Enrollment Period

4.3 years

First QC Date

March 20, 2024

Last Update Submit

March 20, 2024

Conditions

Mechanical Ventilation ComplicationWeaning FailureAcute Respiratory Distress SyndromeHigh-flow Oxygenation

Outcome Measures

Primary Outcomes (1)

  • Weaning failure

    Weaning failure and re-intubation or recanulation

    48 hrs

Study Arms (2)

NIV

ACTIVE COMPARATOR

Non-invasive ventilation

Device: Respiratory support

HFO

ACTIVE COMPARATOR

High Flow Oxygenation

Device: Respiratory support

Interventions

Respiratory supportDEVICE

High-flow nasal oxygenation

Also known as: Oxygenation
HFONIV

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ARDS

You may not qualify if:

  • Severe ICU-aquired weakness Severe COPD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

City hospital # 1

Arkhangelsk, Arkhangelskaya oblast, 163000, Russia

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: Randomized assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the anesthesiology and intensive care department

Study Record Dates

First Submitted

March 20, 2024

First Posted

March 27, 2024

Study Start

September 1, 2017

Primary Completion

January 1, 2022

Study Completion

March 1, 2022

Last Updated

March 27, 2024

Record last verified: 2024-03

Locations

RU(1)