High Flow Nasal Cannula in the Emergency Department (HFNC)

March 2, 2018 updated by: Hospital Italiano de Buenos Aires

Use of High-Flow Nasal Cannula for Acute Respiratory Failure in the Emergency Department

The aim of this study was to describe the changes in respiratory rate, heart rate and dyspnea, before and after using HFNC in patients presenting to our emergency department with ARF.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A retrospective cohort study was performed. To all adults presenting to the emergency department who used high flow nasal cannula to treat clinical signs of acute respiratory failure based on the presence of a breathing frequency ≥ 25 breath/min and increase work of breathing evidence by dyspnea, in-drawing, accessory-muscle use and/or diaphoresis despite conventional oxygen therapy ≥ 6 l/min. Demographic variables and clinical and gasometric parameters before and after two hours using HFNC were recorded.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
43

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with and without a history of lung disease who used high flow nasal cannula. We defined clinical signs of acute respiratory failure based on the presence of a breathing frequency ≥ 25 breath/min and increase work of breathing evidence by dyspnea, in-drawing, accessory-muscle use and/or diaphoresis, despite conventional oxygen therapy ≥ 6 l/min.

Description

Inclusion Criteria:

  • patients aged ≥ 18 years
  • attended between July 1st, 2015 and January 31st , 2017 in the Emergency Department of the Hospital Italiano de Buenos Aires
  • with clinical signs of acute respiratory failure

Exclusion Criteria:

- Pulse oximetry > 90% breathing room air

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Heart Rate
Time Frame: 2 hours
The closest value of Heart Rate before starting HFNC, and two hours later was collected from the electronic clinical history.
2 hours
Respiratory Rate
Time Frame: 2 hours
The closest value of Respiratory Rate before starting HFNC, and two hours later was collected from the electronic clinical history.
2 hours
Dyspnea
Time Frame: 2 hours
The closest value of Dyspnea (Modified Borg Dyspnea scale) before starting HFNC, and two hours later was collected from the electronic clinical history. The Modified Borg Dyspnea Scale is a rated numerical score used to measure dyspnea. This scale has a minimum value of 0 ( represent no dyspnea) and a maximum value of 10 (worse dyspnea).
2 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Initial HFNC setting
Time Frame: 2 hours
The gas flow rate and the fraction of inspired oxygen at the HFNC initiation of treatment were collected from the electronic clinical history.
2 hours
Acute respiratory failure etiology
Time Frame: 3 minutes
Presence of a breathing frequency ≥ 25 breath/min and increase work of breathing evidence by dyspnea, in-drawing, accessory-muscle use and/or diaphoresis despite conventional oxygen therapy ≥ 6 l/min.
3 minutes
Average time of use the HFNC
Time Frame: until 28 days
The total hours of use of HFNC were collected from the electronic clinical history.
until 28 days
Delay of HFNC treatment
Time Frame: until 24hs
The hours between the admission to HFNC initiation were collected from the electronic clinical history.
until 24hs
Efficacy of HFNC treatment
Time Frame: 28 days
When the patient did not need for escalation to other non-invasive or invasive ventilatory support.
28 days
Failure of HFNC treatment
Time Frame: 28 days
When the patient need non-invasive or invasive ventilatory support or died. The type of ventilatory support post-failure were collected from the electronic clinical history.
28 days
Mortality rate at 28 day from ED admission
Time Frame: 28 days
The number of patients who died after requiring HFNCO were collected from the electronic clinical history
28 days
Palliative Care
Time Frame: 28 days
Consensus between patient and/or patient´s family and the physician about the care for the terminally ill patient, provided by an organized health service
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital Italiano de Buenos Aires

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Vanesa R Ruiz, RT, Hospital Italiano de Buenos Aires

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 20, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 9, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 9, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 3106

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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