High Flow Therapy in ICUs Across Ibero America (T-Calfi)

August 8, 2019 updated by: Leopoldo Ferrer, Fundación Santa Fe de Bogota

High Flow Nasal Cannula Technique in Iberoamerica

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

255

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
      • Bogota, Colombia, 111111
        • Clinica Reina Sofia
    • Bogotá
      • Bogota, Bogotá, Colombia, 110111
        • Fundación Santa Fe de Bogotá
    • Pasto
      • Nariño, Pasto, Colombia, 522027
        • Hospital Departamental de Nariño
    • Tolima
      • Ibague, Tolima, Colombia, 730009
        • Medicina Intensiva del Tolima
  • Dominican Republic
      • Santo Domingo, Dominican Republic
        • Instituto Nacional del Cáncer Rosa Emilia Sánchez Pérez de Tavarez (INCART)
  • Mexico
    • Ciudad De México
      • Ciudad de mexico, Ciudad De México, Mexico, 14050
        • Fundación Medica Sur
  • Spain
      • Barcelona, Spain, 08003
        • Hospital del Mar - Parc de Salut Mar
      • Madrid, Spain, 28034
        • Hospital Ramón y Cajal
      • Madrid, Spain, 28033
        • MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
High Nasal Flow Therapy
Every patient in the ICU that requires High Nasal Flow Therapy
Other: No intervention
No intervention, observational study

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Santa Fe de Bogota

Investigators

  • Principal Investigator: Leopoldo E Ferrer, MD, Fundación Santa Fe de Bogotá

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 15, 2018

Primary Completion (ANTICIPATED)

August 1, 2019

Study Completion (ANTICIPATED)

December 15, 2019

Study Registration Dates

First Submitted

November 20, 2017

First Submitted That Met QC Criteria

December 1, 2017

First Posted (ACTUAL)

December 7, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 12, 2019

Last Update Submitted That Met QC Criteria

August 8, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCEI-7327-2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No IPD will be available to external researchers prior to publication

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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