What side effects are associated with this type of intervention?

High flow nasal cannulas (HFNC) are commonly used to treat respiratory failure by providing high flow oxygen to reduce the work of breathing. Known side effects of HFNC include nasal dryness or discomfort, epistaxis (nosebleeds), and, in rare cases, gastric distension due to the high flow rates. Other potential side effects may include skin irritation or pressure sores around the nasal area due to prolonged use of the cannula. Overall, HFNC is generally well-tolerated, but monitoring for these side effects is important.

What prior FDA approvals exist?

The FDA has approved several treatments for respiratory failure that aim to improve oxygenation and reduce the work of breathing. High Flow Nasal Cannulas (HFNC) are a notable example, providing heated and humidified oxygen at high flow rates to support patients with respiratory distress. Other related treatments include non-invasive ventilation (NIV) methods like Continuous Positive Airway Pressure (CPAP) and Bilevel Positive Airway Pressure (BiPAP), which also help reduce the work of breathing by providing positive airway pressure. Additionally, inhaled nitric oxide has been approved for use in certain cases of acute hypoxemic respiratory failure, particularly in neonates, to improve oxygenation by dilating pulmonary vessels.

What other types of research exist?

Promising novel alternatives to High Flow Nasal Cannulas for respiratory failure patients include: 1) Non-invasive ventilatory support such as BiPAP (Bilevel Positive Airway Pressure) and CPAP (Continuous Positive Airway Pressure), which can provide effective respiratory support without the need for intubation. 2) Bronchoscopic treatments like endobronchial valves and lung volume reduction coils, which can improve lung function by reducing hyperinflation in patients with severe emphysema. 3) Advanced mucoactive agents and secretion clearance techniques, including oscillatory positive expiratory pressure (OPEP) devices and high-frequency chest wall oscillation, which help in clearing airway secretions and improving breathing efficiency.

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Oxygen Delivery Device

High Flow Nasal Cannulas for Respiratory Failure (HDWOBPT Trial)

Q: What is the mechanism of action of this treatment?

High flow nasal cannulas (HFNC) deliver heated and humidified oxygen at high flow rates, which reduces the work of breathing by providing a constant positive airway pressure, improving oxygenation, and reducing anatomical dead space. This is crucial for respiratory failure patients as it alleviates hypoxemia, reduces the effort required to breathe, and enhances overall respiratory function and comfort. Additionally, HFNC aids in mucus clearance and lowers the risk of respiratory infections.

N/A

Waitlist Available

Research Sponsored by Laval University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Spontaneously breathing patients exhibiting a respiratory distress defined by a respiratory rate ≥ 20 breaths/min associated with either hypoxemia (SpO2<90% with O2≥3L/min) or hypercapnia (PaCO2>45 mmHg with a respiratory acidosis (pH<7,38))

Be older than 18 years old

Must not have

Patients below 18yo, pregnant or breastfeeding women

Acute respiratory or cardiovascular disease contra-indicating the enrolment in the study protocol (i.e. acute coronary syndrome, pulmonary embolism, pneumothorax)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 minutes

Awards & highlights

No Placebo-Only Group

Summary

This trial tests high flow oxygen therapy delivered through nasal tubes in patients with severe breathing problems. It aims to see if this method makes breathing easier and more comfortable compared to standard oxygen therapy. This new method is being used in adults with severe respiratory disease.

Who is the study for?

This trial is for adults with respiratory failure who are breathing on their own but have rapid breathing and either low oxygen levels despite receiving oxygen or high carbon dioxide levels with acidosis. It's not for those under 18, pregnant/breastfeeding women, patients in other studies, or those with certain ear/nose/throat, digestive, rheumatologic/neurologic conditions.

What is being tested?

The study tests how different flow settings of high flow nasal cannulas affect the work of breathing in patients. Sixteen patients will experience four treatment periods using both conventional masks and a device called Airvo 2; each patient tries all settings in a crossover design.

What are the potential side effects?

While specific side effects aren't listed here, high flow nasal cannula treatments can sometimes cause dryness or irritation in the nose or throat, discomfort from the airflow pressure, and rarely may lead to minor bleeding due to mucosal damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am breathing on my own but have trouble breathing, with either low oxygen levels or high carbon dioxide levels.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am over 18, not pregnant, and not breastfeeding.

Select...

I do not have any recent serious heart or lung problems.

Select...

I need help breathing and my recent blood test shows high acidity.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Work of breathing

Secondary study objectives

Blood gases

Comfort of breathing

Dyspnea

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: High flow nasal cannulas 60L/minExperimental Treatment1 Intervention

Oxygen delivery via high flow nasal cannulas (60L/min) with FiO2 adjusted to reach a target SpO2 according to the patient's condition.

Group II: High flow nasal cannulas 40L/minExperimental Treatment1 Intervention

Oxygen delivery via high flow nasal cannulas (40L/min) with FiO2 adjusted to reach a target SpO2 according to the patient's condition.

Group III: High flow nasal cannulas 20L/minExperimental Treatment1 Intervention

Oxygen delivery via high flow nasal cannulas (20L/min) with fraction of inspired oxygen (FiO2) adjusted to reach a target SpO2 according to the patient's condition.

Group IV: Conventional flow via nasal prongsActive Control1 Intervention

Oxygen delivery via conventional nasal interface with flow adjusted to reach a target SpO2 according to the patient's condition.

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

High flow nasal cannulas (HFNC) deliver heated and humidified oxygen at high flow rates, which reduces the work of breathing by providing a constant positive airway pressure, improving oxygenation, and reducing anatomical dead space. This is crucial for respiratory failure patients as it alleviates hypoxemia, reduces the effort required to breathe, and enhances overall respiratory function and comfort. Additionally, HFNC aids in mucus clearance and lowers the risk of respiratory infections.