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

98 Participants Needed

Trial Summary

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 data supports the effectiveness of this treatment for hypoxia in immunocompromised patients?

Research shows that high-flow nasal cannula (HFNC) can help maintain oxygen levels during bronchoscopy, a procedure that often causes low oxygen levels. HFNC has been found to be effective in preventing hypoxemic events (low oxygen in the blood) in patients undergoing bronchoscopy, suggesting it could be beneficial for immunocompromised patients with hypoxia. ^{1 2 3 4 5}

Is high-flow nasal cannula safe for use in humans?

High-flow nasal cannula (HFNC) has been used safely in various studies for patients undergoing bronchoscopy, helping to maintain oxygen levels and reduce the risk of low oxygen events. It is considered a safe option for providing respiratory support during procedures, even in patients with existing breathing issues. ^{1 3 4 5 6}

How does the treatment of high-flow nasal cannula differ from other treatments for hypoxia in immunocompromised patients?

High-flow nasal cannula (HFNC) is unique because it delivers oxygen at a higher flow rate than standard nasal cannulas, providing better respiratory support and maintaining oxygen levels during procedures like bronchoscopy. This method can offer a continuous positive airway pressure-like effect, which is not typically achieved with low-flow oxygen or standard oxygen therapy. ^{1 2 3 4 5}

What is the purpose of this trial?

Pneumonia is a lung infection. Fiberoptic bronchoscopy is a test to diagnose the type of lung infection. While this procedure is being performed, a small amount of oxygen is delivered into the nose (low flow nasal cannula). Occasionally during this procedure, the blood oxygen of the patient may drop and an intervention such as increasing the oxygen flow, or placing the patient on a breathing machine is required. An alternative device called 'Optiflow' can provide high flow oxygen through nasal cannula, and is comfortable for patients. If Optiflow is used during bronchoscopy, it may prevent the blood oxygen from dropping.

Research Team

Dr. Sangeeta Mehta, MD, FRCPC

Principal Investigator

MOUNT SINAI HOSPITAL

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

High-flow nasal cannula for reducing hypoxemic events in patients undergoing bronchoscopy: A systematic review and meta-analysis of randomized trials. [2023]

2. England pubmed.ncbi.nlm.nih.gov

High-flow nasal cannula oxygen versus non-invasive ventilation in patients with acute hypoxaemic respiratory failure undergoing flexible bronchoscopy--a prospective randomised trial. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Modified high-flow nasal cannula oxygen therapy versus conventional oxygen therapy in patients undergoing bronchoscopy: a randomized clinical trial. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Maintaining Oxygenation Successfully with High Flow Nasal Cannula during Diagnostic Bronchoscopy on a Postoperative Lung Transplant Patient in the Intensive Care. [2020]

5. China pubmed.ncbi.nlm.nih.gov

A prospective randomized comparative study of high-flow nasal cannula oxygen and non-invasive ventilation in hypoxemic patients undergoing diagnostic flexible bronchoscopy. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Incidence of oxygen desaturation using a high-flow nasal cannula versus a facemask during flexible bronchoscopy in patients at risk of hypoxemia: a randomised controlled trial. [2022]