Oxygen Supplementation During Bronchoscopy: High Flow Versus Low Flow Oxygen
Primary Purpose
Hypoxia
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
High flow nasal oxygen supplementation
low flow nasal oxygen supplementation
Sponsored by
About this trial
This is an interventional supportive care trial for Hypoxia focused on measuring bronchoscopy, hypoxia, oxygen supplementation, safety
Eligibility Criteria
Inclusion Criteria:
- patients scheduled to undergo routine bronchoscopy for diagnostic purposes
Exclusion Criteria:
- inability to give an informed consent
- nasal deformities
Sites / Locations
- Shaare Zedek Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Low flow nasal oxygen supplementation
High flow nasal oxygen supplementation
Arm Description
Low flow nasal oxygen supplementation as per routine standard of care(control arm)
High-flow nasal ventilation: This will be carried out using the Precision Flow device (Opti-Flow, Auckland, New Zealand). This device is intended to add warm moisture to breathing gases from an external source. Flow rate via the nasal cannula will be kept at 50 Liters/min and fractional inspired oxygen concentration will be set at 0.35
Outcomes
Primary Outcome Measures
Oxygen desaturation index 4% (ODI4%)
oxygen cumulative time below 88%(OCT88%)
Secondary Outcome Measures
number of bradycardic and tachycardic events
change in expired end tidal carbon dioxide before and after completion of bronchoscopy
oxygen desaturation index 4%
cumulative oxygen time 88%
Full Information
NCT ID
NCT02253706
First Posted
September 2, 2014
Last Updated
September 28, 2014
Sponsor
Shaare Zedek Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02253706
Brief Title
Oxygen Supplementation During Bronchoscopy: High Flow Versus Low Flow Oxygen
Official Title
Oxygen Supplementation During Bronchoscopy: High-Flow Nasal Cannula or Low-Flow Nasal Cannula
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
September 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shaare Zedek Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
In general bronchoscopy is a safe procedure with low rate of complications. Indeed, contraindications to flexible bronchoscopy are mostly relative rather than absolute. This is the case of preexisting decreased blood oxygen levels which may be present in patients requiring further bronchopulmonary investigation. To avoid the deleterious effects of oxygen drops oxygen supplementation is recommended.
The purpose of this study is to evaluate the efficiency and safety of oxygen supplementation obtained with the use of a high flow nasal cannula compared with a low flow nasal cannula during flexible bronchoscopy.
Consecutive patients referred by their treating physician for bronchoscopy will be offered to take part in the study. Those who wish to participate and give their consent will be randomly assigned into one of two treatment groups (supplemental oxygen given via low flow nasal cannula or via high flow nasal cannula).
Assignment to either treatment arm will not affect in any way the intended purpose of the bronchoscopy. All patients will be closely monitored during the procedure and 2 hours following its completion. Monitoring will be conducted, using strictly non-invasive measures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia
Keywords
bronchoscopy, hypoxia, oxygen supplementation, safety
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Low flow nasal oxygen supplementation
Arm Type
Active Comparator
Arm Description
Low flow nasal oxygen supplementation as per routine standard of care(control arm)
Arm Title
High flow nasal oxygen supplementation
Arm Type
Experimental
Arm Description
High-flow nasal ventilation: This will be carried out using the Precision Flow device (Opti-Flow, Auckland, New Zealand). This device is intended to add warm moisture to breathing gases from an external source. Flow rate via the nasal cannula will be kept at 50 Liters/min and fractional inspired oxygen concentration will be set at 0.35
Intervention Type
Device
Intervention Name(s)
High flow nasal oxygen supplementation
Other Intervention Name(s)
Precision Flow device (Opti-Flow, Auckland, New Zealand)
Intervention Description
High-flow nasal ventilation: This will be carried out using the Precision Flow device (Opti-Flow, Auckland, New Zealand). This device is intended to add warm moisture to breathing gases from an external source. Flow rate via the nasal cannula will be kept at 50 Liters/min and fractional inspired oxygen concentration will be set at 0.35.
Intervention Type
Device
Intervention Name(s)
low flow nasal oxygen supplementation
Intervention Description
Low-flow nasal ventilation: This will be carried out using a regular nasal cannula fed with oxygen at flow rates from 2 to 6 liters/minute.
Primary Outcome Measure Information:
Title
Oxygen desaturation index 4% (ODI4%)
Time Frame
duration of bronchoscopy with an expected average duration of 30 minutes
Title
oxygen cumulative time below 88%(OCT88%)
Time Frame
beginning to end of bronchoscopy procedure with an expected average duration of 30minutes
Secondary Outcome Measure Information:
Title
number of bradycardic and tachycardic events
Time Frame
beginning to end of bronchoscopy with an expected averag duration of 30 minutes
Title
change in expired end tidal carbon dioxide before and after completion of bronchoscopy
Time Frame
beginning to end of bronchoscopy with an expected average duration of 30 minutes
Title
oxygen desaturation index 4%
Time Frame
preprocedural to 2 hours post procedure with an expected total duration of 3 hours
Title
cumulative oxygen time 88%
Time Frame
pre-procedural to 2 hours post precedure with an expected total duration of 3 hours
Other Pre-specified Outcome Measures:
Title
patient comfort during the procedure
Description
a numeric rating scale ranging from 1(excellent to 4(poor ) will be filled out by the patient after completion of the bronchoscopy
Time Frame
duration of bronchoscopy procedure with an expected average duration of 30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients scheduled to undergo routine bronchoscopy for diagnostic purposes
Exclusion Criteria:
inability to give an informed consent
nasal deformities
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ayal Romem, MD
Phone
97226555676
Email
pulmoromem@szmc.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayal Romem, MD
Organizational Affiliation
Shaare Zedek Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
3235
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
4809326
Citation
Albertini R, Harrel JH, Moser KM. Letter: Hypoxemia during fiberoptic bronchoscopy. Chest. 1974 Jan;65(1):117-8. doi: 10.1378/chest.65.1.117. No abstract available.
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
23860341
Citation
Du Rand IA, Blaikley J, Booton R, Chaudhuri N, Gupta V, Khalid S, Mandal S, Martin J, Mills J, Navani N, Rahman NM, Wrightson JM, Munavvar M; British Thoracic Society Bronchoscopy Guideline Group. British Thoracic Society guideline for diagnostic flexible bronchoscopy in adults: accredited by NICE. Thorax. 2013 Aug;68 Suppl 1:i1-i44. doi: 10.1136/thoraxjnl-2013-203618. No abstract available.
Results Reference
background
Citation
Roca O, Masclans JR, Laborda C, Sacanell J, Serra J. High-flow nasal cannula improves oxygenation in hypoxemic respiratory failure. Intensive Care Med 2007; 33:S86
Results Reference
background
Citation
Williams AB, Ritchie JE, Gerard C. Evaluation of a high-flow nasal oxygen delivery system: gas analysis and pharyngeal pressures. Intensive Care Med 2006; 32: S219
Results Reference
background
Citation
Lomas C, Roca O, Alvarez A, Masclans JR. Fibroscopy in patients with hypoxemic respiratory insufficiency: Utility of the high-flow nasal cannula. Respr Med (CME) 2009; 2: 121-124
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
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Oxygen Supplementation During Bronchoscopy: High Flow Versus Low Flow Oxygen
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