search
Back to results

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

Primary Purpose

Immunocompromised, Hematologic Malignancy, Post Hematopoietic Stem Cell Transplant

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
High Flow Nasal Cannula or Low Flow Nasal Cannula
Sponsored by
Mount Sinai Hospital, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Immunocompromised focused on measuring HFNC, Bronchoscopy, Hypoxia, Immunocompromised, Hematological malignancy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mount Sinai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High Flow Nasal Cannula (HFNC)

Low Flow Nasal Cannula (LFNC)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 24, 2017
Last Updated
October 17, 2023
Sponsor
Mount Sinai Hospital, Canada
Collaborators
Princess Margaret Hospital, Canada
search

1. Study Identification

Unique Protocol Identification Number
NCT03168815
Brief Title
Low-Flow vs. High-Flow Nasal Cannula for Hypoxemic Immunocompromised Patients During Diagnostic Bronchoscopy
Official Title
Low-Flow vs. High-Flow Nasal Cannula for Hypoxemic Immunocompromised Patients During Diagnostic Bronchoscopy: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 10, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mount Sinai Hospital, Canada
Collaborators
Princess Margaret Hospital, Canada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immunocompromised, Hematologic Malignancy, Post Hematopoietic Stem Cell Transplant, Hypoxia, Pulmonary Infiltrates
Keywords
HFNC, Bronchoscopy, Hypoxia, Immunocompromised, Hematological malignancy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
98 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High Flow Nasal Cannula (HFNC)
Arm Type
Experimental
Arm Description
Oxygen is delivered at 50 L/min with FiO2 50% delivered for at least 5 min prior to FOB and throughout the procedure.
Arm Title
Low Flow Nasal Cannula (LFNC)
Arm Type
Active Comparator
Arm Description
Oxygen is delivered at 6L/min applied for at least 5 minutes prior to FOB and throughout the procedure.
Intervention Type
Device
Intervention Name(s)
High Flow Nasal Cannula or Low Flow Nasal Cannula
Intervention Description
HFNC vs LFNC
Primary Outcome Measure Information:
Title
Desaturation during FOB
Description
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.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Sangeeta Mehta, MD, FRCPC
Organizational Affiliation
MOUNT SINAI HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17932672
Citation
Hummel M, Rudert S, Hof H, Hehlmann R, Buchheidt D. Diagnostic yield of bronchoscopy with bronchoalveolar lavage in febrile patients with hematologic malignancies and pulmonary infiltrates. Ann Hematol. 2008 Apr;87(4):291-7. doi: 10.1007/s00277-007-0391-6. Epub 2007 Oct 12.
Results Reference
background
PubMed Identifier
19684637
Citation
Shannon VR, Andersson BS, Lei X, Champlin RE, Kontoyiannis DP. Utility of early versus late fiberoptic bronchoscopy in the evaluation of new pulmonary infiltrates following hematopoietic stem cell transplantation. Bone Marrow Transplant. 2010 Apr;45(4):647-55. doi: 10.1038/bmt.2009.203. Epub 2009 Aug 17.
Results Reference
background
PubMed Identifier
19415277
Citation
Kuehnhardt D, Hannemann M, Schmidt B, Heider U, Possinger K, Eucker J. Therapeutic implication of BAL in patients with neutropenia. Ann Hematol. 2009 Dec;88(12):1249-56. doi: 10.1007/s00277-009-0747-1. Epub 2009 May 5.
Results Reference
background
PubMed Identifier
11209099
Citation
Hohenadel IA, Kiworr M, Genitsariotis R, Zeidler D, Lorenz J. Role of bronchoalveolar lavage in immunocompromised patients with pneumonia treated with a broad spectrum antibiotic and antifungal regimen. Thorax. 2001 Feb;56(2):115-20. doi: 10.1136/thorax.56.2.115.
Results Reference
background
PubMed Identifier
2200319
Citation
Goldstein RA, Rohatgi PK, Bergofsky EH, Block ER, Daniele RP, Dantzker DR, Davis GS, Hunninghake GW, King TE Jr, Metzger WJ, et al. Clinical role of bronchoalveolar lavage in adults with pulmonary disease. Am Rev Respir Dis. 1990 Aug;142(2):481-6. doi: 10.1164/ajrccm/142.2.481.
Results Reference
background
PubMed Identifier
6744959
Citation
Matsushima Y, Jones RL, King EG, Moysa G, Alton JD. Alterations in pulmonary mechanics and gas exchange during routine fiberoptic bronchoscopy. Chest. 1984 Aug;86(2):184-8. doi: 10.1378/chest.86.2.184.
Results Reference
background
PubMed Identifier
26420333
Citation
Schnabel RM, van der Velden K, Osinski A, Rohde G, Roekaerts PM, Bergmans DC. Clinical course and complications following diagnostic bronchoalveolar lavage in critically ill mechanically ventilated patients. BMC Pulm Med. 2015 Sep 29;15:107. doi: 10.1186/s12890-015-0104-1.
Results Reference
background
PubMed Identifier
10988131
Citation
Maitre B, Jaber S, Maggiore SM, Bergot E, Richard JC, Bakthiari H, Housset B, Boussignac G, Brochard L. Continuous positive airway pressure during fiberoptic bronchoscopy in hypoxemic patients. A randomized double-blind study using a new device. Am J Respir Crit Care Med. 2000 Sep;162(3 Pt 1):1063-7. doi: 10.1164/ajrccm.162.3.9910117.
Results Reference
background
PubMed Identifier
25981908
Citation
Frat JP, Thille AW, Mercat A, Girault C, Ragot S, Perbet S, Prat G, Boulain T, Morawiec E, Cottereau A, Devaquet J, Nseir S, Razazi K, Mira JP, Argaud L, Chakarian JC, Ricard JD, Wittebole X, Chevalier S, Herbland A, Fartoukh M, Constantin JM, Tonnelier JM, Pierrot M, Mathonnet A, Beduneau G, Deletage-Metreau C, Richard JC, Brochard L, Robert R; FLORALI Study Group; REVA Network. High-flow oxygen through nasal cannula in acute hypoxemic respiratory failure. N Engl J Med. 2015 Jun 4;372(23):2185-96. doi: 10.1056/NEJMoa1503326. Epub 2015 May 17.
Results Reference
background
PubMed Identifier
27245914
Citation
Frat JP, Ragot S, Girault C, Perbet S, Prat G, Boulain T, Demoule A, Ricard JD, Coudroy R, Robert R, Mercat A, Brochard L, Thille AW; REVA network. Effect of non-invasive oxygenation strategies in immunocompromised patients with severe acute respiratory failure: a post-hoc analysis of a randomised trial. Lancet Respir Med. 2016 Aug;4(8):646-652. doi: 10.1016/S2213-2600(16)30093-5. Epub 2016 May 27.
Results Reference
background
PubMed Identifier
25866645
Citation
Nishimura M. High-flow nasal cannula oxygen therapy in adults. J Intensive Care. 2015 Mar 31;3(1):15. doi: 10.1186/s40560-015-0084-5. eCollection 2015.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
25478241
Citation
Diab S, Fraser JF. Maintaining Oxygenation Successfully with High Flow Nasal Cannula during Diagnostic Bronchoscopy on a Postoperative Lung Transplant Patient in the Intensive Care. Case Rep Crit Care. 2014;2014:198262. doi: 10.1155/2014/198262. Epub 2014 Nov 13.
Results Reference
background
PubMed Identifier
25169847
Citation
Miyagi K, Haranaga S, Higa F, Tateyama M, Fujita J. Implementation of bronchoalveolar lavage using a high-flow nasal cannula in five cases of acute respiratory failure. Respir Investig. 2014 Sep;52(5):310-4. doi: 10.1016/j.resinv.2014.06.006. Epub 2014 Jul 25.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
22666567
Citation
Lucangelo U, Vassallo FG, Marras E, Ferluga M, Beziza E, Comuzzi L, Berlot G, Zin WA. High-flow nasal interface improves oxygenation in patients undergoing bronchoscopy. Crit Care Res Pract. 2012;2012:506382. doi: 10.1155/2012/506382. Epub 2012 May 20.
Results Reference
background
PubMed Identifier
25529351
Citation
Simon M, Braune S, Frings D, Wiontzek AK, Klose H, Kluge S. High-flow nasal cannula oxygen versus non-invasive ventilation in patients with acute hypoxaemic respiratory failure undergoing flexible bronchoscopy--a prospective randomised trial. Crit Care. 2014 Dec 22;18(6):712. doi: 10.1186/s13054-014-0712-9.
Results Reference
background
PubMed Identifier
19846404
Citation
Parke R, McGuinness S, Eccleston M. Nasal high-flow therapy delivers low level positive airway pressure. Br J Anaesth. 2009 Dec;103(6):886-90. doi: 10.1093/bja/aep280. Epub 2009 Oct 20.
Results Reference
background
PubMed Identifier
11948045
Citation
Antonelli M, Conti G, Rocco M, Arcangeli A, Cavaliere F, Proietti R, Meduri GU. Noninvasive positive-pressure ventilation vs. conventional oxygen supplementation in hypoxemic patients undergoing diagnostic bronchoscopy. Chest. 2002 Apr;121(4):1149-54. doi: 10.1378/chest.121.4.1149.
Results Reference
background
PubMed Identifier
26869676
Citation
La Combe B, Messika J, Labbe V, Razazi K, Maitre B, Sztrymf B, Dreyfuss D, Fartoukh M, Ricard JD. High-flow nasal oxygen for bronchoalveolar lavage in acute respiratory failure patients. Eur Respir J. 2016 Apr;47(4):1283-6. doi: 10.1183/13993003.01883-2015. Epub 2016 Feb 11. No abstract available.
Results Reference
background
PubMed Identifier
16924893
Citation
Fang WF, Chen YC, Chung YH, Woon WT, Tseng CC, Chang HW, Lin MC. Predictors of oxygen desaturation in patients undergoing diagnostic bronchoscopy. Chang Gung Med J. 2006 May-Jun;29(3):306-12.
Results Reference
background
Citation
23. Chris Hau (respiratory therapist - Princess Margaret Hospital), Clodagh Ryan (Respirologist, Princess Margaret Hospital, Geeta Mehta (Respirologist, Princess Margaret Hospital) (personal communication, November 2016)
Results Reference
background
PubMed Identifier
25479117
Citation
Miguel-Montanes R, Hajage D, Messika J, Bertrand F, Gaudry S, Rafat C, Labbe V, Dufour N, Jean-Baptiste S, Bedet A, Dreyfuss D, Ricard JD. Use of high-flow nasal cannula oxygen therapy to prevent desaturation during tracheal intubation of intensive care patients with mild-to-moderate hypoxemia. Crit Care Med. 2015 Mar;43(3):574-83. doi: 10.1097/CCM.0000000000000743.
Results Reference
background
PubMed Identifier
27478191
Citation
La Combe B, Messika J, Fartoukh M, Ricard JD. Increased use of high-flow nasal oxygen during bronchoscopy. Eur Respir J. 2016 Aug;48(2):590-2. doi: 10.1183/13993003.00565-2016. No abstract available.
Results Reference
background
PubMed Identifier
27478190
Citation
Santos PS, Cruz C, Esquinas AM. Increased use of high-flow nasal oxygen during bronchoscopy. Eur Respir J. 2016 Aug;48(2):589. doi: 10.1183/13993003.00441-2016. No abstract available.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs