Low-Flow vs. High-Flow Nasal Cannula for Hypoxia in Immunocompromised Patients

Overseen By Dr. Sangeeta Mehta, MD, FRCPC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mount Sinai Hospital, Canada

Disqualifiers: High oxygen needs, Hypercapnia, NIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a high-flow nasal cannula (a device that delivers oxygen to the nose) is more effective than a low-flow nasal cannula during bronchoscopy. The researchers aim to determine if the high-flow device can prevent drops in blood oxygen levels for immunocompromised patients, such as those with certain cancers or post-transplant, who experience breathing problems due to lung infections. Suitable participants are adults needing bronchoscopy who already use low-flow oxygen to maintain stable oxygen levels. As an unphased trial, this study provides a unique opportunity to contribute to important research that could enhance care for patients with breathing difficulties.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Optiflow device is safe for use during bronchoscopy?

Research has shown that high-flow nasal cannula (HFNC) oxygen therapy is generally safe and easy for patients to manage. Studies have found that HFNC can help patients leave the hospital sooner and causes less dryness in the nose and mouth compared to other oxygen methods. For instance, a study with over 700 patients found that the death rate was similar for those using HFNC and those using standard oxygen therapy, indicating no major safety concerns.

Conversely, the low-flow nasal cannula (LFNC) is a common method for providing oxygen and is used in hospitals worldwide. Since this trial compares two existing oxygen delivery methods and not a new drug or device, no major safety issues have been reported with either treatment. Both HFNC and LFNC are considered safe ways to deliver oxygen to patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how different levels of oxygen delivery can help manage hypoxia in immunocompromised patients. Unlike the standard of care, which typically involves low-flow oxygen methods, this trial investigates the potential benefits of using a high-flow nasal cannula (HFNC). HFNC delivers oxygen at a much higher rate, providing better oxygenation and possibly improving patient comfort during procedures like bronchoscopy. By comparing HFNC with traditional low-flow methods, researchers hope to find more effective ways to support patients with compromised immune systems during medical procedures.

What evidence suggests that this trial's treatments could be effective for hypoxia in immunocompromised patients?

This trial will compare the effectiveness of high-flow nasal cannula (HFNC) and low-flow nasal cannula (LFNC) for patients with hypoxia who are immunocompromised. Research has shown that HFNC therapy can improve oxygen levels in patients with weakened immune systems who have trouble breathing. Studies have found that HFNC leads to better outcomes, such as shorter hospital stays and less dryness in the nose and mouth, compared to other oxygen treatments. It also reduces the need for a breathing tube. In contrast, LFNC is less effective at maintaining steady oxygen levels during medical procedures. Overall, HFNC offers more benefits for patients with low blood oxygen levels during procedures like bronchoscopy. ^{2 3 5 6 7}

Who Is on the Research Team?

Dr. Sangeeta Mehta, MD, FRCPC

Principal Investigator

MOUNT SINAI HOSPITAL

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are immunocompromised due to blood cancers or bone marrow transplant, need extra oxygen to keep their blood levels normal, and are scheduled for a lung infection test called FOB. It's not for those with high carbon dioxide levels in their blood, severe acidosis, already using high-flow oxygen, needing very high oxygen before the study starts, or with nasal issues that prevent using the devices.

Exclusion Criteria

You have very high carbon dioxide levels in your blood or your body has too much acid in it from breathing problems.

You were using high-flow nasal cannula (HFNC) before the study started.

You need to use a breathing machine for more than 1 hour, or have a tube in your throat to help you breathe.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo fiberoptic bronchoscopy with either high-flow or low-flow nasal cannula oxygen delivery

1 day

1 visit (in-person)

Follow-up

Participants are monitored for desaturation during and 1 hour post-bronchoscopy

1 hour

What Are the Treatments Tested in This Trial?

Interventions

• Diagnostic Bronchoscopy
• High Flow Nasal Cannula
• Low Flow Nasal Cannula

Trial Overview The trial tests two ways of giving extra oxygen during a lung infection test (FOB): one uses low flow through the nose (usual method), and the other uses 'Optiflow' which gives higher flow comfortably. The goal is to see if Optiflow can better prevent drops in blood oxygen levels during the procedure.

How Is the Trial Designed?

Group I: High Flow Nasal Cannula (HFNC) Experimental Treatment 1 Intervention

Oxygen is delivered at 50 L/min with FiO2 50% delivered for at least 5 min prior to FOB and throughout the procedure.

Group II: Low Flow Nasal Cannula (LFNC) Active Control 1 Intervention

Oxygen is delivered at 6L/min applied for at least 5 minutes prior to FOB and throughout the procedure.

Who Is Running the Clinical Trial?

Mount Sinai Hospital, Canada

Lead Sponsor

Trials

210

Recruited

70,700+

Princess Margaret Hospital, Canada

Collaborator

Trials

121

Recruited

40,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6560523/

High-flow nasal cannula oxygen therapy in ... Improved oxygenation 48 hours after high-flow nasal cannula oxygen therapy is associated with good outcome in immunocompromised patients with acute respiratory ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0954611125001192

Outcomes of high-flow versus conventional oxygen therapy ... HFNC was associated with shorter hospital LOS and lower rates of nose/mouth dryness compared to other non-invasive oxygen techniques.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02978300

NCT02978300 | HFNC Alone or Associated With NIV for ... Likewise in a retrospective monocentric cohort of immunocompromized patients, we reported better outcomes with HFNC than with NIV. Official Title. High-Flow ...

4. jtd.amegroups.org jtd.amegroups.org/article/view/25267/html

Improved oxygenation 48 hours after high-flow nasal cannula ... Improved oxygenation 48 hours after high-flow nasal cannula oxygen therapy is associated with good outcome in immunocompromised patients with acute respiratory

5. jintensivecare.biomedcentral.com jintensivecare.biomedcentral.com/articles/10.1186/s40560-023-00667-2

Comparison of the efficacy and comfort of high-flow nasal ... The high initial flow settings (50–60 L/min) performed better in decreasing the occurrence of intubation and mortality, albeit with poor comfort scores.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11499756/

Effect of high-flow nasal cannula oxygen versus standard ... The primary outcome is the number of patients who died 28 days after randomisation. Secondary outcomes include comfort, dyspnoea and oxygenation ...

7. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2796693

Effect of High-Flow Nasal Cannula Oxygen vs Standard ... Findings In this randomized clinical trial that included 711 patients, mortality at day 28 was 10% in the high-flow oxygen group and 11% in the ...