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

Sponsor
Mount Sinai Hospital, Canada (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03168815
Collaborator
Princess Margaret Hospital, Canada (Other)
98
1
2
59.7
1.6

Study Details

Study Description

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
  • Device: High Flow Nasal Cannula or Low Flow Nasal Cannula
N/A

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

Study Type:
Interventional
Anticipated 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.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 :
Jan 10, 2018
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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

Primary Outcome Measures

  1. Desaturation during FOB [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

Criteria

Ages Eligible for Study:
18 Years and Older
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:
  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

Locations

Site City State Country Postal Code
1 Mount Sinai Hospital Toronto Ontario Canada M5G 1X5

Sponsors and Collaborators

  • Mount Sinai Hospital, Canada
  • Princess Margaret Hospital, Canada

Investigators

  • Principal Investigator: Dr. Sangeeta Mehta, MD, FRCPC, MOUNT SINAI HOSPITAL

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Sangeeta Mehta, Professor, Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier:
NCT03168815
Other Study ID Numbers:
  • vSep2016
First Posted:
May 30, 2017
Last Update Posted:
Apr 5, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sangeeta Mehta, Professor, Mount Sinai Hospital, Canada
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 5, 2022