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Active, Not Recruiting

NCT Number: NCT03168815

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High Flow Nasal Cannula or Low Flow Nasal Cannula

Device

HFNC vs LFNC

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Mount Sinai Hospital, Canada

Other

Collaborators

  • Princess Margaret Hospital, Canada

Registry information

Official study title

Low-Flow vs. High-Flow Nasal Cannula for Hypoxemic Immunocompromised Patients During Diagnostic Bronchoscopy: A Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
May 30, 2017
Registry last updated
May 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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