High Flow Therapy in ICUs Across Ibero America

• Conditions: Hypoxia; Hypercapnic Respiratory Failure; Ventilatory Failure; Nasal High Flow Therapy; Intensive Care Unit

• Registration Number: NCT03364946
• Lead Sponsor: Fundación Santa Fe de Bogota

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 available

Study Timeline

• Study First Submitted: 2017-11-20
• Study First Submitted QC: 2017-12-01
• Study First Posted: 2017-12-07
• Study Start: 2018-05-15
• Status Verified: 2019-08
• Primary Completion: 2019-08-01
• Last Update Submitted: 2019-08-08
• Last Update Posted: 2019-08-12
• Study Completion: 2019-12-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 255

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (9)

Fundación Santa Fe de Bogotá; 🇨🇴 Bogota, Bogotá, Colombia

Hospital Departamental de Nariño; 🇨🇴 Nariño, Pasto, Colombia

Medicina Intensiva del Tolima; 🇨🇴 Ibague, Tolima, Colombia

Clinica Reina Sofia; 🇨🇴 Bogota, 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, Mexico

Hospital del Mar - Parc de Salut Mar; 🇪🇸 Barcelona, Spain

MD Anderson Cancer Center; 🇪🇸 Madrid, Spain

Hospital Ramon y Cajal; 🇪🇸 Madrid, Spain