Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03168815
Recruitment Status : Recruiting
First Posted : May 30, 2017
Last Update Posted : February 24, 2021
Sponsor:
Collaborator:
Princess Margaret Hospital, Canada
Information provided by (Responsible Party):
Sangeeta Mehta, Mount Sinai Hospital, Canada

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Immunocompromised Hematologic Malignancy Post Hematopoietic Stem Cell Transplant Hypoxia Pulmonary Infiltrates Device: High Flow Nasal Cannula or Low Flow Nasal Cannula Not Applicable

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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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, 2021
Estimated Study Completion Date : December 31, 2021
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.
 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.
 Device: High Flow Nasal Cannula or Low Flow Nasal Cannula
HFNC vs LFNC


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Dr. Sangeeta Mehta, MD, FRCPC 416-586-4800 ext 4604 geeta.mehta@utoronto.ca
Contact: Dr. Laveena Munshi, MD, FRCPC 416-586-4800 ext 6571 Laveena.Munshi@sinaihealthsystem.ca

Locations
Layout table for location information
Canada, Ontario
Mount Sinai Hospital Recruiting
Toronto, Ontario, Canada, M5G 1X5
Principal Investigator: Sangeeta Mehta, MD         
Sub-Investigator: Laveena Munshi, MD         
Sponsors and Collaborators
Mount Sinai Hospital, Canada
Princess Margaret Hospital, Canada
Investigators
Layout table for investigator information
Principal Investigator: Dr. Sangeeta Mehta, MD, FRCPC MOUNT SINAI HOSPITAL
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:
Lomas C, Roca O, Alvarez A, et al. Fibroscopy in patients with hypoxemic respiratory insufficiency: Utility of the high-flow nasal cannula. Respiratory Medicine CME 2009;2:121.
16. Kim KC, Hyun DS. Usefulness of high-flow nasal cannula (HFNC) oxygen delivery during bronchoalveolar lavage (BAL) in spontaneous breathing patients with hypoxemia. European Respiratory Journal. 2014; 44: p706.
23. Chris Hau (respiratory therapist - Princess Margaret Hospital), Clodagh Ryan (Respirologist, Princess Margaret Hospital, Geeta Mehta (Respirologist, Princess Margaret Hospital) (personal communication, November 2016)

Layout table for additonal information
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: February 24, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sangeeta Mehta, Mount Sinai Hospital, Canada:
HFNC
Bronchoscopy
Hypoxia
Immunocompromised
Hematological malignancy
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms
Hematologic Neoplasms
Hypoxia
 Signs and Symptoms, Respiratory
Neoplasms by Site
Hematologic Diseases