HypoxiaNCT02253706
Oxygen Supplementation During Bronchoscopy: High Flow Versus Low Flow Oxygen
A study testing High flow nasal oxygen supplementation and low flow nasal oxygen supplementation in people with Hypoxia, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoxia
- What is being tested?
- High flow nasal oxygen supplementation and low flow nasal oxygen supplementation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2014to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients scheduled to undergo routine bronchoscopy for diagnostic purposes
Who cannot join
- inability to give an informed consent
- nasal deformities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oxygen Supplementation During Bronchoscopy: High-Flow Nasal Cannula or Low-Flow Nasal Cannula
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.
Read more
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.
- Conditions
- Hypoxia
- Being tested
- High flow nasal oxygen supplementation, low flow nasal oxygen supplementation
- Keywords
- bronchoscopy, hypoxia, oxygen supplementation, safety
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High flow nasal oxygen supplementationDevice
Also called Precision Flow device (Opti-Flow, Auckland, New Zealand)
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.
low flow nasal oxygen supplementationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Low flow nasal oxygen supplementation | Active comparator | Low flow nasal oxygen supplementation as per routine standard of care(control arm) Receives: Device: low flow nasal oxygen supplementation |
| High flow nasal oxygen supplementation | Experimental | 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 Receives: Device: High flow nasal oxygen supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen desaturation index 4% (ODI4%)
Measured: duration of bronchoscopy with an expected average duration of 30 minutes
oxygen cumulative time below 88%(OCT88%)
Measured: beginning to end of bronchoscopy procedure with an expected average duration of 30minutes
Secondary outcomes (4)
number of bradycardic and tachycardic events
Measured: beginning to end of bronchoscopy with an expected averag duration of 30 minutes
change in expired end tidal carbon dioxide before and after completion of bronchoscopy
Measured: beginning to end of bronchoscopy with an expected average duration of 30 minutes
oxygen desaturation index 4%
Measured: preprocedural to 2 hours post procedure with an expected total duration of 3 hours
cumulative oxygen time 88%
Measured: pre-procedural to 2 hours post precedure with an expected total duration of 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionSep 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for HypoxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ayal Romem, MD, Principal investigator, Shaare Zedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02253706
- Sponsor's protocol ID
- HFO-Rx1
- Status last verified
- Jul 2014
- First submitted
- 2 Sep 2014
- Last updated
- 1 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 4809326Matsushima 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.
PubMed 6744959Du 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.
PubMed 23860341Roca 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
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
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
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.
PubMed 22666567
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxygen Supplementation During Bronchoscopy: High-Flow Nasal Cannula or Low-Flow Nasal Cannula
- ClinicalTrials.gov ID
- NCT02253706
- Acronym / sponsor ID
- HFO-Rx1
- Conditions
- Hypoxia
- Keywords
- bronchoscopy, hypoxia, oxygen supplementation, safety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 1 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low flow nasal oxygen supplementation | Active comparator | Device: low flow nasal oxygen supplementationLow flow nasal oxygen supplementation as per routine standard of care(control arm) |
| High flow nasal oxygen supplementation | Experimental | Device: High flow nasal oxygen supplementationHigh-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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients scheduled to undergo routine bronchoscopy for diagnostic purposes
Key exclusion criteria (2 listed)
- inability to give an informed consent
- nasal deformities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High flow nasal oxygen supplementationAlso: Precision Flow device (Opti-Flow, Auckland, New Zealand)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. | Device | High flow nasal oxygen supplementation |
| low flow nasal oxygen supplementationLow-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. | Device | Low flow nasal oxygen supplementation |
Primary outcome
Oxygen desaturation index 4% (ODI4%)
Time frame: duration of bronchoscopy with an expected average duration of 30 minutes
oxygen cumulative time below 88%(OCT88%)
Time frame: beginning to end of bronchoscopy procedure with an expected average duration of 30minutes
4 secondary outcomes
number of bradycardic and tachycardic events
Time frame: beginning to end of bronchoscopy with an expected averag duration of 30 minutes
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
oxygen desaturation index 4%
Time frame: preprocedural to 2 hours post procedure with an expected total duration of 3 hours
cumulative oxygen time 88%
Time frame: pre-procedural to 2 hours post precedure with an expected total duration of 3 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2014.
- Background: PubMed 4809326Albertini 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.
- Background: PubMed 6744959Matsushima 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.
- Background: PubMed 23860341Du 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.
- BackgroundRoca 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
- BackgroundWilliams 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
- BackgroundLomas 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
- Background: PubMed 22666567Lucangelo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayal Romem, MD principal investigator
Shaare Zedek Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High flow nasal oxygen supplementation and low flow nasal oxygen supplementation in people with Hypoxia, run by Shaare Zedek Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayal Romem, MD (97226555676, pulmoromem@szmc.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen desaturation index 4% (ODI4%) (time frame: duration of bronchoscopy with an expected average duration of 30 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02253706, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2014.