ClinicalTrials.gg
Status unknownNCT03364946T-CalfiUpdated Aug 12, 2019

High Flow Therapy in ICUs Across Ibero America

An observational study in Nasal High Flow Therapy, Intensive Care Unit and Ventilatory Failure, sponsored by Fundación Santa Fe de Bogota. Status unknown at 9 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-12.

Sponsored by Fundación Santa Fe de Bogota · Observational

The sponsor has not verified this record recently (last verified Aug 2019), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
255
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

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

Hypoventilation

96 studies on the registry are indexed under Hypoventilation; 21 are open to participants now.

This study's planned enrollment of 255 is above the median of 74 across 28 observational studies indexed under Hypoventilation.

Browse Hypoventilation studies →

Lead sponsor

Fundación Santa Fe de Bogota is the lead sponsor of 27 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Other
Time perspective
Cross-sectional
Enrollment
255 participants (estimated)
Target follow-up
30 Days
Patient registry
Yes

Groups and cohorts

  • High Nasal Flow Therapy

    Every patient in the ICU that requires High Nasal Flow Therapy

    Other: No intervention

Interventions

  • OtherNo intervention

    No intervention, observational study

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What researchers measure

Primary outcomes

  1. Hypoxemia

    PO2 under 60mmHg, or SatO2 under 80%; that leads to the instauration of invasive ventilation

    Time frame: 15 days

  2. Tachypnea

    Respiratory rate over 20; that leads to the instauration of invasive ventilation

    Time frame: 15 days

  3. Hypercapnia

    PCO2 over 55mmHg; that leads to the instauration of invasive ventilation

    Time frame: 15 days

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Study locations

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

Individual participant data

Plan to share: No — No IPD will be available to external researchers prior to publication

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 12, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03364946
Lead sponsor
Fundación Santa Fe de Bogota
Responsible party
Leopoldo Ferrer (Principal investigator, Fundación Santa Fe de Bogota) — Principal investigator
First posted
Dec 7, 2017
Start date
May 15, 2018
Primary completion
Aug 1, 2019 (estimated)
Completion
Dec 15, 2019 (estimated)
Last update
Aug 12, 2019

Study contacts

Leopoldo E Ferrer, MD
principal investigator · Fundación Santa Fe de Bogotá

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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