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NCT03364946 Clinical Trial

High Flow Therapy in ICUs Across Ibero America

Hypoxia Clinical Trial

— T-Calfi  

Official title:
High Flow Nasal Cannula Technique in Iberoamerica

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03364946
Other study ID # CCEI-7327-2017
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date May 15, 2018
Est. completion date December 15, 2019

Study information
Verified date August 2019
Source Fundación Santa Fe de Bogota
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 255
Est. completion date December 15, 2019
Est. primary completion date August 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• No intervention
No intervention, observational study

Locations
Country Name City State
Colombia Clinica Reina Sofia Bogota
Colombia Fundación Santa Fe de Bogotá Bogota Bogotá
Colombia Medicina Intensiva del Tolima Ibague Tolima
Colombia Hospital Departamental de Nariño Nariño Pasto
Dominican Republic Instituto Nacional del Cáncer Rosa Emilia Sánchez Pérez de Tavarez (INCART) Santo Domingo
Mexico Fundación Medica Sur Ciudad de mexico Ciudad De México
Spain Hospital del Mar - Parc de Salut Mar Barcelona
Spain Hospital Ramon y Cajal Madrid
Spain MD Anderson Cancer Center Madrid

Sponsors (1)
Lead Sponsor Collaborator
Fundación Santa Fe de Bogota

Countries where clinical trial is conducted

Colombia,  Dominican Republic,  Mexico,  Spain, 

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