Nasal High Flow TherapyT-CalfiNCT03364946
High Flow Therapy in ICUs Across Ibero America
An observational study of Nasal High Flow Therapy and Intensive Care Unit, run by Fundación Santa Fe de Bogota at 9 sites in 4 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasal High Flow Therapy, Intensive Care Unit, Ventilatory Failure
- How many people
- 255 participants
- Where
- 9 sitesin 4 countries
- Study dates
- 15 May 2018to 15 Dec 2019
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Over 18 years old
- Admitted to medical or surgical ICU
- Requirement of high nasal flow therapy
Who cannot join
- Post-extubation failure
- Patient unable to protect airway
- Diagnosed shock
- Glasgow equal or under 8
Trial locations and contacts
9 sites in 4 countries.
9 sites in 4 countries
Colombia4 sites
Fundación Santa Fe de Bogotá
Bogotá, Bogota D.C., 110111
Clinica Reina Sofia
Bogotá, 111111
Medicina Intensiva del Tolima
Ibague, Tolima Department, 730009
Hospital Departamental de Nariño
Nariño, Pasto, 522027
Spain3 sites
Hospital del Mar - Parc de Salut Mar
Barcelona, 08003
MD Anderson Cancer Center
Madrid, 28033
Hospital Ramon y Cajal
Madrid, 28034
Dominican Republic1 site
Instituto Nacional del Cáncer Rosa Emilia Sánchez Pérez de Tavarez (INCART)
Santo Domingo
About this study
Official title: 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.
- Conditions
- Nasal High Flow Therapy, Intensive Care Unit, Ventilatory Failure, Hypoxia, Hypercapnic Respiratory Failure
- Being tested
- No intervention
- Medical subject headings
- Hypoventilation, Hypoxia, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention, observational study
| Study group | Role | What they receive |
|---|---|---|
| High Nasal Flow Therapy | Every patient in the ICU that requires High Nasal Flow Therapy Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoxemia
PO2 under 60mmHg, or SatO2 under 80%; that leads to the instauration of invasive ventilation
Measured: 15 days
Tachypnea
Respiratory rate over 20; that leads to the instauration of invasive ventilation
Measured: 15 days
Hypercapnia
PCO2 over 55mmHg; that leads to the instauration of invasive ventilation
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2017
- Study start15 May 2018
- Primary completion1 Aug 2019 (estimated)
- Study completion15 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal High Flow TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 255 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Fundación Santa Fe de Bogota
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leopoldo Ferrer, Fundación Santa Fe de Bogota
- Investigators
- Leopoldo E Ferrer, MD, Principal investigator, Fundación Santa Fe de Bogotá
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03364946
- Sponsor's protocol ID
- CCEI-7327-2017
- Acronym
- T-Calfi
- Status last verified
- Aug 2019
- First submitted
- 20 Nov 2017
- Last updated
- 12 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be available to external researchers prior to publication
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Flow Nasal Cannula Technique in Iberoamerica
- ClinicalTrials.gov ID
- NCT03364946
- Acronym / sponsor ID
- T-Calfi / CCEI-7327-2017
- Conditions
- Nasal High Flow Therapy, Intensive Care Unit, Ventilatory Failure, Hypoxia, Hypercapnic Respiratory Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 255 participants (estimated)
- Lead sponsor
- Fundación Santa Fe de BogotaUniversity, hospital or other
- Study start
- 15 May 2018 (actual)
- Primary completion
- 1 Aug 2019 (estimated)
- Study completion
- 15 Dec 2019 (estimated)
- First posted
- 7 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High Nasal Flow Therapy | – | Other: No interventionEvery patient in the ICU that requires High Nasal Flow Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- Over 18 years old
- Admitted to medical or surgical ICU
- Requirement of high nasal flow therapy
Key exclusion criteria (4 listed)
- Post-extubation failure
- Patient unable to protect airway
- Diagnosed shock
- Glasgow equal or under 8
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention, observational study | Other | High Nasal Flow Therapy |
Primary outcome
Hypoxemia
Time frame: 15 days
PO2 under 60mmHg, or SatO2 under 80%; that leads to the instauration of invasive ventilation
Tachypnea
Time frame: 15 days
Respiratory rate over 20; that leads to the instauration of invasive ventilation
Hypercapnia
Time frame: 15 days
PCO2 over 55mmHg; that leads to the instauration of invasive ventilation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2019.
- Individual participant dataSharing planned: No. No IPD will be available to external researchers prior to publication
Related trials for Nasal High Flow Therapy
RecruitingObservational study
Predicting High-Flow Nasal Oxygen Failure Within 72 Hours Using a Physiology-Informed Dual-Domain Model at 30 Minutes
Acute Respiratory Failure, Electrical Impedance Tomography (EIT)
Recruiting
Physiological Effects of Continuous Negative External Pressure for Acute Hypoxemic Respiratory Failure
Acute Hypoxemic Respiratory Failure
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruiting
Protocolized Weaning of High-Flow Nasal Cannula in Adult Patients
Acute Hypoxemic Respiratory Failure, High-Flow Nasal Cannula Therapy
Active, not recruitingObservational study
Examining the Effects of Nasal High Flow Oxygen Therapy Compared to Non-invasive Ventilation in Health Volunteers
Healthy Volunteers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leopoldo E Ferrer, MD principal investigator
Fundación Santa Fe de Bogotá
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nasal High Flow Therapy and Intensive Care Unit, run by Fundación Santa Fe de Bogota at 9 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Colombia, Spain, Dominican Republic, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypoxemia (time frame: 15 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2019.