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

NCT03168815 | Active Not Recruiting

• 1 other identifier: vSep2016
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

HFNC; Bronchoscopy; Hypoxia; Immunocompromised; Hematological malignancy

Outcome Measures

Primary Outcomes (1)

• Desaturation during FOB

  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.

  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.

Study Arms (2)

High Flow Nasal Cannula (HFNC)

EXPERIMENTAL

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

Device: High Flow Nasal Cannula or Low Flow Nasal Cannula

Low Flow Nasal Cannula (LFNC)

ACTIVE COMPARATOR

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

Device: High Flow Nasal Cannula or Low Flow Nasal Cannula

Interventions

High Flow Nasal Cannula or Low Flow Nasal Cannula DEVICE

HFNC vs LFNC

High Flow Nasal Cannula (HFNC); Low Flow Nasal Cannula (LFNC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead
• Princess Margaret Hospital, Canada: collaborator

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Related Publications (25)

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• 23. Chris Hau (respiratory therapist - Princess Margaret Hospital), Clodagh Ryan (Respirologist, Princess Margaret Hospital, Geeta Mehta (Respirologist, Princess Margaret Hospital) (personal communication, November 2016)

  BACKGROUND

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MeSH Terms

Conditions

Hematologic Neoplasms; Hypoxia

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dr. Sangeeta Mehta, MD, FRCPC

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 24, 2017
• First Posted: May 30, 2017
• Study Start: January 10, 2018
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)