Low-Flow vs. High-Flow Nasal Cannula for Hypoxemic Immunocompromised Patients During Diagnostic Bronchoscopy

NCT ID: NCT03168815

Last Updated: 2025-05-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-10
• Study Completion Date: 2025-12-31

Brief Summary

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.

Detailed Description

Pneumonia is a lung infection that is a common complication in people with cancer, because of a weak immune system. Fiberoptic bronchoscopy is a test that is commonly used to help doctors diagnose the type of lung infection and treat it appropriately. It involves passing a thin tube with a camera at the end inside the lungs, and taking some fluid samples which are sent for analysis. 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 (even if the patient is receiving oxygen, and especially if the patient has severe pneumonia), and the procedure may have to be interrupted or prematurely stopped. If the oxygen level drops significantly, an intervention such as increasing the oxygen flow, or in the worst-case scenario temporarily 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. Optiflow was approved by Health Canada in 2006, and is commonly used in hospitals in Ontario and around the world to support patients whose blood oxygen is low. If Optiflow is used during bronchoscopy, it may prevent the blood oxygen from dropping.

Conditions

Immunocompromised; Hematologic Malignancy; Post Hematopoietic Stem Cell Transplant; Hypoxia; Pulmonary Infiltrates

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

High Flow Nasal Cannula (HFNC)

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

Group Type: EXPERIMENTAL

High Flow Nasal Cannula or Low Flow Nasal Cannula

Intervention Type: DEVICE

HFNC vs LFNC

Low Flow Nasal Cannula (LFNC)

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

Group Type: ACTIVE_COMPARATOR

High Flow Nasal Cannula or Low Flow Nasal Cannula

Intervention Type: DEVICE

HFNC vs LFNC

Interventions

High Flow Nasal Cannula or Low Flow Nasal Cannula

HFNC vs LFNC

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Adult patients ≥18 years scheduled to undergo FOB (as determined by their medical care team) who are immunocompromised (active hematologic malignancy or post hematopoietic stem cell transplant), and are hypoxic with pulmonary infiltrates. Hypoxia will be defined as requiring supplemental low flow oxygen ≥ 2L/min by nasal cannula to maintain SpO2 >90%.

Exclusion Criteria

1. requiring supplemental oxygen > 8L/min by nasal cannula;

2. receiving HFNC before randomization;

3. nasal deformity or packing precluding HFNC use;

4. hypercapnia (PaCO2 > 60) or respiratory acidosis (pH <7.25);

5. requiring NIV for over 1 hour or intubated.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Princess Margaret Hospital, Canada

OTHER

Sponsor Role: collaborator

Mount Sinai Hospital, Canada

OTHER

Sponsor Role: lead

Responsible Party

Sangeeta Mehta

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dr. Sangeeta Mehta, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

MOUNT SINAI HOSPITAL

Locations

Mount Sinai Hospital

Toronto, Ontario, Canada

Countries

Canada

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Other Identifiers

vSep2016

Identifier Type: -

Identifier Source: org_study_id