NIV Versus HFO Versus Standard Therapy Immediately After... | NCT06332768

Status Module

Record Verification Date

Mar 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

Sep 1, 2017Actual

Primary Completion Date

Jan 1, 2022Actual

Completion Date

Mar 1, 2022Actual

First Submitted Date

Mar 20, 2024

First Submission Date that Met QC Criteria

Mar 20, 2024

First Posted Date

Mar 27, 2024Actual

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

Mar 20, 2024

Last Update Posted Date

Mar 27, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mikhail Y. Kirov, Head of the anesthesiology and intensive care department, Northern State Medical UniversityPrincipal Investigator

Lead Sponsor

Northern State Medical UniversityOTHER

Collaborators

Not provided

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

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.

Detailed Description

HFNO (high-flow nasal oxygenation and NIV (non invasive ventilation) are to be randomly compared in the ARDS postextubation period.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NIV	Active Comparator	Non-invasive ventilation	Device: Respiratory support
HFO	Active Comparator	High Flow Oxygenation	Device: Respiratory support

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Respiratory support	Device	High-flow nasal oxygenation	HFO NIV

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Weaning failure	Weaning failure and re-intubation or recanulation	48 hrs

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ARDS

Exclusion Criteria:

Severe ICU-aquired weakness Severe COPD

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
City hospital # 1		Arkhangelsk	Arkhangelskaya oblast	163000	Russia

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D012120	Respiration Disorders