Respiratory FailureNCT05708287
The Physiologic Effect of the Flow Generated by High Flow Nasal Cannula in Mild Respiratory Failure
A study testing HFNC in people with Respiratory Failure, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
High flow nasal cannula (HFNC) oxygen therapy is increasingly used for hypoxemic respiratory failure and is proving useful in avoiding or delaying intubation and mechanical ventilation. However, basic information regarding the physiologic effects of this method is missing. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- HFNC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Aug 2020to 31 Dec 2020
- Phase
- Interventional
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Minimal age 18
- The patient had invasive blood pressure monitoring via an arterial line in situ
- The patient had a mild respiratory failure manifested by the need for oxygen support via nasal prongs in order to maintain oxygen saturation (SpO2) above 90% for at least one hour prior to the start of the intervention
Who cannot join
- Shortness of breath
- Patients regularly using O2 at home
- No patient consent for participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Physiologic Effect of the Flow Generated by High Flow Nasal Cannula in Mild Respiratory Failure a Prospective Study
High flow nasal cannula (HFNC) oxygen therapy is increasingly used for hypoxemic respiratory failure and is proving useful in avoiding or delaying intubation and mechanical ventilation. However, basic information regarding the physiologic effects of this method is missing. In this study, the effects of oxygen delivery by HFNC on oxygenation, ventilation and cardiovascular vital signs in patients with mild hypoxemic respiratory failure were evaluated.
Read the detailed description
Oxygen (O2) therapy delivered by means of High Flow Nasal Cannula (HFNC) is being increasingly used. This device, capable of delivering high flow, oxygen enriched gas, has been shown to reduce intubation rates in patients with hypoxemic respiratory failure. The primary components of HFNC are "nasal prongs" (or cannulae) that are inserted into the nostrils, a device which provides a warmed and humidified air / oxygen mixture and regulators that control oxygen concentration, temperature and total gas flow. Commercially available systems can deliver up to 40 - 60 liters per minute (LPM) of oxygen flow.
This method of non-invasive oxygen delivery has several presumed important working principals. Firstly, the high flow rate may meet the patient's own inspiratory flow rate. This enables accurate delivery of a high fractional inspired concentration of oxygen (FiO2). Second, the high gas flow might also produce a certain degree of Continuous Positive Airway Pressure (CPAP). In addition, the heated and humidified gas might also wash out/reduce the physiological airway dead space of the patient. Furthermore, HFNC is more comfortable and might be better tolerated than other Non-Invasive Ventilation (NIV) devices, such as Bi-level positive airway pressure (BiPAP). This, in turn, can prolong the time the patient is comfortably connected to the HFNC device.
Information regarding the basic physiologic influence of HFNC on oxygenation, ventilation and vital signs is missing in the literature. Patients with mild respiratory failure provide an opportunity to examine this topic. On one hand, these patients suffer from respiratory failure manifested by hypoxemia, on the other hand the respiratory failure is mild to the extent that removal of the conventional oxygen therapy (COT) will not lead to immediate respiratory collapse. This prospective study evaluates the physiologic effects of HFNC in 28 patients with mild respiratory failure.
- Conditions
- Respiratory Failure
- Being tested
- HFNC
- Keywords
- high flow nasal cannula, oxygenation, ventilation, conventional oxygen therapy, Arterial Blood Gasses
- Medical subject headings
- Respiratory Insufficiency, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HFNCDevice
The patients with mild hypoxemia, defined as the need for conventional oxygen therapy (COT) using nasal cannula at 4-5 liters per minute (LPM) to maintain O2 Saturation >90%, were commenced on HFNC therapy
| Study group | Role | What they receive |
|---|---|---|
| all patients | Experimental | Not described Receives: Device: HFNC |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of changing flow rates generated by HFNC on oxygenation parameters of 28 patients with mild respiratory failure
Change in PaO2 in mmHg(Partial pressure of oxygen in arterial blood) from baseline on nasal cannula and after giving gradually increasing flow rates to 60 Liters Per Minute on HFNC, at constant FiO2 of 40%.
Measured: 60 minutes
The effect of changing flow rates generated by HFNC on ventilation parameters of 28 patients with mild respiratory failure
Change in PaCO2 in mmHg(Partial pressure of carbon dioxide in arterial blood) from baseline on nasal cannula and after giving gradually increasing flow rates to 60 Liters Per Minute on HFNC, at constant FiO2 of 40%.
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start1 Aug 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05708287
- Sponsor's protocol ID
- HMO-20-0260
- Status last verified
- Dec 2022
- First submitted
- 14 Dec 2022
- Last updated
- 1 Feb 2023
- 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 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Physiologic Effect of the Flow Generated by High Flow Nasal Cannula in Mild Respiratory Failure a Prospective Study
- ClinicalTrials.gov ID
- NCT05708287
- Acronym / sponsor ID
- HMO-20-0260
- Conditions
- Respiratory Failure
- Keywords
- high flow nasal cannula, oxygenation, ventilation, conventional oxygen therapy, Arterial Blood Gasses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 1 Feb 2023 (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) oxygen therapy is increasingly used for hypoxemic respiratory failure and is proving useful in avoiding or delaying intubation and mechanical ventilation. However, basic information regarding the physiologic effects of this method is missing. In this study, the effects of oxygen delivery by HFNC on oxygenation, ventilation and cardiovascular vital signs in patients with mild hypoxemic respiratory failure were evaluated.
Detailed description
Oxygen (O2) therapy delivered by means of High Flow Nasal Cannula (HFNC) is being increasingly used. This device, capable of delivering high flow, oxygen enriched gas, has been shown to reduce intubation rates in patients with hypoxemic respiratory failure. The primary components of HFNC are "nasal prongs" (or cannulae) that are inserted into the nostrils, a device which provides a warmed and humidified air / oxygen mixture and regulators that control oxygen concentration, temperature and total gas flow. Commercially available systems can deliver up to 40 - 60 liters per minute (LPM) of oxygen flow.
This method of non-invasive oxygen delivery has several presumed important working principals. Firstly, the high flow rate may meet the patient's own inspiratory flow rate. This enables accurate delivery of a high fractional inspired concentration of oxygen (FiO2). Second, the high gas flow might also produce a certain degree of Continuous Positive Airway Pressure (CPAP). In addition, the heated and humidified gas might also wash out/reduce the physiological airway dead space of the patient. Furthermore, HFNC is more comfortable and might be better tolerated than other Non-Invasive Ventilation (NIV) devices, such as Bi-level positive airway pressure (BiPAP). This, in turn, can prolong the time the patient is comfortably connected to the HFNC device.
Information regarding the basic physiologic influence of HFNC on oxygenation, ventilation and vital signs is missing in the literature. Patients with mild respiratory failure provide an opportunity to examine this topic. On one hand, these patients suffer from respiratory failure manifested by hypoxemia, on the other hand the respiratory failure is mild to the extent that removal of the conventional oxygen therapy (COT) will not lead to immediate respiratory collapse. This prospective study evaluates the physiologic effects of HFNC in 28 patients with mild respiratory failure.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| all patients | Experimental | Device: HFNC |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Minimal age 18
- The patient had invasive blood pressure monitoring via an arterial line in situ
- The patient had a mild respiratory failure manifested by the need for oxygen support via nasal prongs in order to maintain oxygen saturation (SpO2) above 90% for at least one hour prior to the start of the intervention
Key exclusion criteria (3 listed)
- Shortness of breath
- Patients regularly using O2 at home
- No patient consent for participation
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 |
|---|---|---|
| HFNCThe patients with mild hypoxemia, defined as the need for conventional oxygen therapy (COT) using nasal cannula at 4-5 liters per minute (LPM) to maintain O2 Saturation >90%, were commenced on HFNC therapy | Device | all patients |
Primary outcome
The effect of changing flow rates generated by HFNC on oxygenation parameters of 28 patients with mild respiratory failure
Time frame: 60 minutes
Change in PaO2 in mmHg(Partial pressure of oxygen in arterial blood) from baseline on nasal cannula and after giving gradually increasing flow rates to 60 Liters Per Minute on HFNC, at constant FiO2 of 40%.
The effect of changing flow rates generated by HFNC on ventilation parameters of 28 patients with mild respiratory failure
Time frame: 60 minutes
Change in PaCO2 in mmHg(Partial pressure of carbon dioxide in arterial blood) from baseline on nasal cannula and after giving gradually increasing flow rates to 60 Liters Per Minute on HFNC, at constant FiO2 of 40%.
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 1 Feb 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HFNC in people with Respiratory Failure, run by Hadassah Medical Organization at 1 site in Israel.
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 3 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 1 Feb 2023. 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 Israel. 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?
The effect of changing flow rates generated by HFNC on oxygenation parameters of 28 patients with mild respiratory failure (time frame: 60 minutes). 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 1 Feb 2023.