NCT02834325

Brief Summary

The purpose of the study was to describe early predictors and to develop a prediction tool that accurately identifies the need for mechanical ventilation in pneumonia patients with acute respiratory failure treated with High Flow nasal cannula.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
201

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2009

Longer than P75 for all trials

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

January 1, 2009

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2015

Completed
11 months until next milestone

First Posted

Study publicly available on registry

July 15, 2016

Completed
Last Updated

July 15, 2016

Status Verified

July 1, 2016

Enrollment Period

3.9 years

First QC Date

August 31, 2015

Last Update Submit

July 12, 2016

Conditions

Acute Respiratory FailurePneumonia

Keywords

high flow nasal cannulasuccessfailureROX index

Outcome Measures

Primary Outcomes (1)

  • prediction of need for mechanical ventilation using ROX index

    participants will be followed during their stay in the ICU registering the days with HFNC treatment and their need or not for mechanical ventilation.

    through study completion, an average of 1 year

Study Arms (2)

exit

HFNC with no need for mechanical ventilation

failure

HFNC with need for mechanical ventilation

Procedure: mechanical ventilation

Interventions

mechanical ventilationPROCEDURE
failure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with acute respiratory failure admitted to intensive care unit receiving high-flow nasal cannula treatment.

You may qualify if:

  • diagnosis of acute respiratory failure secondary to pneumonia receiving HFNC therapy

You may not qualify if:

  • younger than 18 years old
  • indication for mechanical ventilation at ICU admission
  • limitation of therapeutic effort

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pneumonia

Interventions

Respiration, Artificial

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsResuscitationEmergency TreatmentRespiratory Therapy

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2015

First Posted

July 15, 2016

Study Start

January 1, 2009

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

July 15, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share