High Flow Therapy in ICUs Across Ibero America | NCT03364946

Studies
High Flow Therapy in ICUs Across Ibero America

NCT03364946

Sponsor

Fundación Santa Fe de Bogota

Status

Unknown status

Last Update Posted

Aug 12, 2019Actual

Enrollment

255Estimated

Phase

Not provided

Conditions

Nasal High Flow Therapy
Intensive Care Unit
Ventilatory Failure
Hypoxia
Hypercapnic Respiratory Failure

Interventions

No intervention

Countries

Colombia
Dominican Republic
Mexico
Spain

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

Aug 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 15, 2018Actual

Primary Completion Date

Aug 1, 2019Estimated

Completion Date

Dec 15, 2019Estimated

First Submitted Date

Nov 20, 2017

First Submission Date that Met QC Criteria

Dec 1, 2017

First Posted Date

Dec 7, 2017Actual

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

Aug 8, 2019

Last Update Posted Date

Aug 12, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Leopoldo Ferrer, Principal investigator, Fundación Santa Fe de BogotaPrincipal Investigator

Lead Sponsor

Fundación Santa Fe de BogotaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 study aims to describe the use of Nasal High Flow (NHF) in the intensive care units of participating centers in Iberoamerica. It will describe the indications for the use, the clinical outcome of patients , and the therapeutic failure of NHF therapy in patients staying in an intensive care unit in the participant centers in Iberoamerica.

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

Yes

Target Follow-Up Duration

30 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

255Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
High Nasal Flow Therapy		Every patient in the ICU that requires High Nasal Flow Therapy	Other: No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	No intervention, observational study	High Nasal Flow Therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hypoxemia	PO2 under 60mmHg, or SatO2 under 80%; that leads to the instauration of invasive ventilation	15 days
Tachypnea	Respiratory rate over 20; that leads to the instauration of invasive ventilation	15 days
Hypercapnia	PCO2 over 55mmHg; that leads to the instauration of invasive ventilation	15 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Over 18 years old
Admitted to medical or surgical ICU
Requirement of high nasal flow therapy

Exclusion Criteria:

Post-extubation failure
Patient unable to protect airway
Diagnosed shock
Glasgow equal or under 8

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

Patients over 18 years old, admitted to an ICU in the reference centers in Iberoamerica, requiring the use of high nasal flow therapy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Leopoldo E Ferrer, MD	Fundación Santa Fe de Bogotá	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fundación Santa Fe de Bogotá		Bogotá	Bogota D.C.	110111	Colombia
Hospital Departamental de Nariño

IPD Sharing Statement Module

Plan to Share IPD

Description

No IPD will be available to external researchers prior to publication

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007040	Hypoventilation
D000860	Hypoxia
D012131	Respiratory Insufficiency

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided