HFNC and Acute Hypercapnic Respiratory Failure

October 21, 2019 updated by: Gustavo Plotnikow, Argentinian Intensive Care Society

High Flow Nasal Oxygen Therapy in Chronic Obstructive Pulmonary Disease (COPD) Patients With Acute Hypercapnic Respiratory Failure (AHRF)

High-flow nasal cannula (HFNC) enables delivering humidified gas at high-flow rates controlling the oxygen inspired fraction (FiO2). Its efficacy has been demonstrated in hypoxemic acute respiratory failure. However, little is known about its use in hypercapnic acute respiratory failure (ARF). Therefore, we aimed to evaluate the effect of using HFNC through "Precision Flow" equipment as first line of ventilatory support for COPD patients with hypercapnic acute respiratory failure.

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.

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.
40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Caba, Argentina, 1425
        • Sanatorio Anchorena

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

Probability Sample

Study Population

Moderate to very severe COPD patients (GOLD 2 to 4) admitted to the ICU with acute hypercapnic respiratory failure

Description

Inclusion Criteria:

  • Moderate to very severe COPD patients (GOLD 2 to 4) over 18 years old admitted to the ICU with hypercapnic ARF (PaCO2> 45 mmHg and respiratory acidosis [pH ≥7.30], with or without hypoxemia + one of the following: Respiratory Rate ≥25 cycles per minute, intercostal and / or supraclavicular recruitment, or thoraco-abdominal synchrony, no prior use of NIV)

Exclusion Criteria:

  • Patients less than 18 years old
  • Mild COPD patients
  • Absence of hypercapnia
  • Kelly M Score > 3
  • Haemodynamic instability (despite fluid resuscitation)
  • NIV or Invasive Mechanical Ventilation (IMV) (Need to use previously to HFNC)
  • Contraindications to implement high-flow oxygen therapy.

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
Need for non-invasive ventilation
Time Frame: From inclussion study date until the first day of noninvasive ventilation use documented, after high flow oxygen therapy use or death date from any cause, whichever came first, assessed up to 4 weeks.
The need and causes for non-invasive ventilation will be recorded in the all study period.
From inclussion study date until the first day of noninvasive ventilation use documented, after high flow oxygen therapy use or death date from any cause, whichever came first, assessed up to 4 weeks.
Need for endotracheal intubation
Time Frame: From inclussion study date until the first day of endotracheal intubation documented, after high flow oxygen therapy use or death date from any cause, whichever came first, assessed up to 4 weeks.
The need and causes for endotracheal intubation will be recorded in the all study period.
From inclussion study date until the first day of endotracheal intubation documented, after high flow oxygen therapy use or death date from any cause, whichever came first, assessed up to 4 weeks.

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
Gas Exchange
Time Frame: Arterial blood gases will be recorded 1, 24 hours and every 24 hours after enrollment
pH will be recorded
Arterial blood gases will be recorded 1, 24 hours and every 24 hours after enrollment
Gas Exchange
Time Frame: Arterial blood gases will be recorded 1, 24 hours and every 24 hours after enrollment
PaCO2 in milimeters of mercury (mmHg) will be recorded
Arterial blood gases will be recorded 1, 24 hours and every 24 hours after enrollment
Gas Exchange
Time Frame: Arterial blood gases will be recorded 1, 24 hours and every 24 hours after enrollment
PaO2 in milimeters of mercury (mmHg) will be recorded
Arterial blood gases will be recorded 1, 24 hours and every 24 hours after enrollment
Respiratory variables
Time Frame: Respiratory variables will be recorded at 1, 2, 3, 6, 12, 24 hours and every 24 hours after enrollment
Respiratory rate in numbers of breaths per minute (bpm) will be recorded
Respiratory variables will be recorded at 1, 2, 3, 6, 12, 24 hours and every 24 hours after enrollment
Respiratory variables
Time Frame: Respiratory variables will be recorded at 1, 2, 3, 6, 12, 24 hours and every 24 hours after enrollment
Accessory muscular use (intercostal or supraclavicular) by "YES or NO" will be recorded
Respiratory variables will be recorded at 1, 2, 3, 6, 12, 24 hours and every 24 hours after enrollment
Respiratory variables
Time Frame: Respiratory variables will be recorded at 1, 2, 3, 6, 12, 24 hours and every 24 hours after enrollment
Thoraco-abdominal asynchrony by "YES or NO" will be recorded
Respiratory variables will be recorded at 1, 2, 3, 6, 12, 24 hours and every 24 hours after enrollment
Patient's discomfort
Time Frame: Patient's discomfort will be recorded at 1, 2, 3, 6, 12, 24 hours and every 24 hours after enrollment
Discomfort related to the high flow oxygen therapy and related to the degree of humidification will be assessed by using a numerical rating scale from 1 (no discomfort) to 5 (maximum imaginable discomfort). Patients will be asked to rate their discomfort with the used device and discomfort symptoms will be determined for the dryness of the delivered oxygen (dryness of the mouth, throat, nose, difficulty to swallow and throat pain).
Patient's discomfort will be recorded at 1, 2, 3, 6, 12, 24 hours and every 24 hours after enrollment

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.
Argentinian Intensive Care Society

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.
  • Study Director: Gustavo A Plotnikow, Sanatorio Anchorena Recoleta
  • Principal Investigator: Mariano Setten, Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" (CEMIC)
  • Principal Investigator: Norberto Tiribelli, Complejo Médico Policial Churruca-Visca
  • Principal Investigator: Sebastian Fredes, Sanatorio de la Trinidad Mitre
  • Principal Investigator: Matias Accoce, Sanatorio Anchorena San Martín

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.
August 1, 2018

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.
September 30, 2019

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.
September 30, 2019

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).
September 24, 2019

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.
September 27, 2019

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.
September 30, 2019

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.
October 23, 2019

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.
October 21, 2019

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.
October 1, 2019

More Information

Terms related to this study

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.
  • Hi-VNI in AHRF

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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