High Flow Therapy in ICUs Across Ibero America

NCT03364946 | Unknown DMC

• 1 other identifier: CCEI-7327-2017
• Study Type: observational
• Target: 255
• Locations: 4 countries
• Sites: 9

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

High Nasal Flow Therapy

Every patient in the ICU that requires High Nasal Flow Therapy

Other: No intervention

Interventions

No intervention OTHER

No intervention, observational study

High Nasal Flow Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fundación Santa Fe de Bogota: lead

Study Sites (9)

Fundación Santa Fe de Bogotá

Bogotá, Bogota D.C., 110111, Colombia

Location

Hospital Departamental de Nariño

Nariño, Pasto, 522027, Colombia

Location

Medicina Intensiva del Tolima

Ibagué, Tolima Department, 730009, Colombia

Location

Clinica Reina Sofia

Bogotá, 111111, Colombia

Location

Instituto Nacional del Cáncer Rosa Emilia Sánchez Pérez de Tavarez (INCART)

Santo Domingo, Dominican Republic

Location

Fundación Medica Sur

Mexico City, Mexico City, 14050, Mexico

Location

Hospital del Mar - Parc de Salut Mar

Barcelona, 08003, Spain

Location

MD Anderson Cancer Center

Madrid, 28033, Spain

Location

Hospital Ramon y Cajal

Madrid, 28034, Spain

Location

MeSH Terms

Conditions

Hypoventilation; Hypoxia; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Leopoldo E Ferrer, MD

  Fundación Santa Fe de Bogotá

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: December 7, 2017
• Study Start: May 15, 2018
• Primary Completion: August 1, 2019
• Study Completion: December 15, 2019
• Last Updated: August 12, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CO (4); DO (1); ME (1); ES (3)