High Flow Oxygen TherapyNCT04109560
HFNC and Acute Hypercapnic Respiratory Failure
An observational study of High Flow Oxygen Therapy and Acute Hypercapnic Respiratory Failure, run by Argentinian Intensive Care Society at 1 site in Argentina.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Flow Oxygen Therapy, Acute Hypercapnic Respiratory Failure, COPD Exacerbation
- How many people
- 40 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Aug 2018to 30 Sep 2019
- 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: Moderate to very severe COPD patients (GOLD 2 to 4) admitted to the ICU with acute hypercapnic respiratory failure
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Medical subject headings
- Respiratory Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for non-invasive ventilation
The need and causes for non-invasive ventilation will be recorded in the all study period.
Measured: 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
The need and causes for endotracheal intubation will be recorded in the all study period.
Measured: 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 outcomes (7)
Gas Exchange
pH will be recorded
Measured: Arterial blood gases will be recorded 1, 24 hours and every 24 hours after enrollment
Gas Exchange
PaCO2 in milimeters of mercury (mmHg) will be recorded
Measured: Arterial blood gases will be recorded 1, 24 hours and every 24 hours after enrollment
Gas Exchange
PaO2 in milimeters of mercury (mmHg) will be recorded
Measured: Arterial blood gases will be recorded 1, 24 hours and every 24 hours after enrollment
Respiratory variables
Respiratory rate in numbers of breaths per minute (bpm) will be recorded
Measured: Respiratory variables will be recorded at 1, 2, 3, 6, 12, 24 hours and every 24 hours after enrollment
Respiratory variables
Accessory muscular use (intercostal or supraclavicular) by "YES or NO" will be recorded
Measured: Respiratory variables will be recorded at 1, 2, 3, 6, 12, 24 hours and every 24 hours after enrollment
Respiratory variables
Thoraco-abdominal asynchrony by "YES or NO" will be recorded
Measured: Respiratory variables will be recorded at 1, 2, 3, 6, 12, 24 hours and every 24 hours after enrollment
Patient's discomfort
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).
Measured: Patient's discomfort will be recorded at 1, 2, 3, 6, 12, 24 hours and every 24 hours after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study start1 Aug 2018
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Flow Oxygen 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Argentinian Intensive Care Society
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gustavo Plotnikow, Argentinian Intensive Care Society
- Investigators
- Gustavo A Plotnikow, Study director, Sanatorio Anchorena RecoletaMariano Setten, Principal investigator, Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno" (CEMIC)Norberto Tiribelli, Principal investigator, Complejo Médico Policial Churruca-ViscaSebastian Fredes, Principal investigator, Sanatorio de la Trinidad MitreMatias Accoce, Principal investigator, Sanatorio Anchorena San Martín
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04109560
- Sponsor's protocol ID
- Hi-VNI in AHRF
- Status last verified
- Oct 2019
- First submitted
- 24 Sep 2019
- Last updated
- 23 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Flow Nasal Oxygen Therapy in Chronic Obstructive Pulmonary Disease (COPD) Patients With Acute Hypercapnic Respiratory Failure (AHRF)
- ClinicalTrials.gov ID
- NCT04109560
- Acronym / sponsor ID
- Hi-VNI in AHRF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Argentinian Intensive Care SocietyUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 30 Sep 2019 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Moderate to very severe COPD patients (GOLD 2 to 4) admitted to the ICU with acute hypercapnic respiratory failure
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (7 listed)
- Patients less than 18 years old
- Mild COPD patients
- Absence of hypercapnia
- Kelly M Score > 3
- Haemodynamic instability (despite fluid resuscitation)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
7 secondary outcomes
Gas Exchange
Time frame: 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
Gas Exchange
Time frame: 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 variables
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2019.
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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.
Gustavo A Plotnikow study director
Sanatorio Anchorena Recoleta
Mariano Setten principal investigator
Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno" (CEMIC)
Norberto Tiribelli principal investigator
Complejo Médico Policial Churruca-Visca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of High Flow Oxygen Therapy and Acute Hypercapnic Respiratory Failure, run by Argentinian Intensive Care Society at 1 site in Argentina.
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 1 inclusion and 7 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: finished, as of the sponsor's last update on 23 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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 study lists 2 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 23 Oct 2019.