Low-Flow vs. High-Flow Nasal Cannula for Hypoxemic Immunocompromised Patients During Diagnostic Bronchoscopy
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ClinicalTrials.gov Identifier: NCT03168815 |
Recruitment Status :
Active, not recruiting
First Posted : May 30, 2017
Last Update Posted : April 5, 2022
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Condition or disease | Intervention/treatment | Phase |
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Immunocompromised Hematologic Malignancy Post Hematopoietic Stem Cell Transplant Hypoxia Pulmonary Infiltrates | Device: High Flow Nasal Cannula or Low Flow Nasal Cannula | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 98 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Patients will be randomized to either HFNC delivered at 50 L/min with FiO2 50% delivered for at least 5 min prior to FOB and throughout the procedure; or to conventional supplemental LFNC delivered at 6L/min applied for at least 5 minutes prior to FOB and throughout the procedure. |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Low-Flow vs. High-Flow Nasal Cannula for Hypoxemic Immunocompromised Patients During Diagnostic Bronchoscopy: A Randomized Controlled Trial |
Actual Study Start Date : | January 10, 2018 |
Estimated Primary Completion Date : | December 31, 2022 |
Estimated Study Completion Date : | December 31, 2022 |
Arm | Intervention/treatment |
---|---|
Experimental: 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.
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Device: High Flow Nasal Cannula or Low Flow Nasal Cannula
HFNC vs LFNC |
Active Comparator: Low Flow Nasal Cannula (LFNC)
Oxygen is delivered at 6L/min applied for at least 5 minutes prior to FOB and throughout the procedure.
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Device: High Flow Nasal Cannula or Low Flow Nasal Cannula
HFNC vs LFNC |
- Desaturation during FOB [ Time Frame: The SpO2 will be measured using a bedside SpO2 measuring device during or 1 hour post-FOB defined as a drop in SpO2 of 4% or more for > 1 minute or any drop in O2 <90% necessitating an increase in FiO2 to maintain a saturation ≥92% for at least 1 minute. ]Any desaturation during FOB or during the 1 hour post-FOB defined as a drop in SpO2 of 4% or more for more than 1 minute or any drop in O2 less than 90%, and necessitating an increase in FiO2 to maintain a saturation ≥92% for at least 1 minute.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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:
- requiring supplemental oxygen > 8L/min by nasal cannula;
- receiving HFNC before randomization;
- nasal deformity or packing precluding HFNC use;
- hypercapnia (PaCO2 > 60) or respiratory acidosis (pH <7.25);
- requiring NIV for over 1 hour or intubated.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03168815
Canada, Ontario | |
Mount Sinai Hospital | |
Toronto, Ontario, Canada, M5G 1X5 |
Principal Investigator: | Dr. Sangeeta Mehta, MD, FRCPC | MOUNT SINAI HOSPITAL |
Responsible Party: | Sangeeta Mehta, Professor, Mount Sinai Hospital, Canada |
ClinicalTrials.gov Identifier: | NCT03168815 |
Other Study ID Numbers: |
vSep2016 |
First Posted: | May 30, 2017 Key Record Dates |
Last Update Posted: | April 5, 2022 |
Last Verified: | April 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
HFNC Bronchoscopy Hypoxia Immunocompromised Hematological malignancy |
Neoplasms Hematologic Neoplasms Hypoxia |
Signs and Symptoms, Respiratory Neoplasms by Site Hematologic Diseases |