Bronchoscopy,OxygenNCT02606188
Modified HFNC Oxygen in Patients Undergoing Bronchoscopy.
A study testing Modified High-flow nasal cannula and nasal cannula in people with Bronchoscopy,Oxygen, run by Haichao Li at 1 site in China.
Trial summary
The purpose of this study is to determine whether the Modified High-flow nasal cannula is effective in the oxygen of the patients undergoing bronchoscopy. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Bronchoscopy,Oxygen
- What is being tested?
- Modified High-flow nasal cannula and nasal cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 812 participants
- Where
- 1 siteChina
- Study dates
- Nov 2015to Dec 2019
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age more than 18 years old;
- need for bronchoscopy for diagnosis purpose.
Who cannot join
- peripheral arterial pulse oximetry was < 90%
- platelet count < 60 × 109/L;
- nasopharyngeal obstruction or blockage.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of respiratory and critical care medicine,Beijing Chaoyang Hospital
Beijing, Beijing Municipality, 100020
About this study
Official title: Modified High-flow Nasal Cannula Oxygen in Patients Undergoing Bronchoscopy.
The purpose of this study is to determine whether the Modified High-flow nasal cannula is effective in the oxygen of the patients undergoing bronchoscopy.
- Conditions
- Bronchoscopy,Oxygen
- Being tested
- Modified High-flow nasal cannula, nasal cannula
- Keywords
- Modified High-flow nasal cannula, Bronchoscopy, Oxygen therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified High-flow nasal cannulaDevice
Modified High-flow nasal cannula
nasal cannulaDevice
Conventional oxygen therap
| Study group | Role | What they receive |
|---|---|---|
| Modified High-flow nasal cannula therapy | Active comparator | Patients undergoing bronchoscopy are given Modified High-flow nasal cannula oxygen therapy all the time. Receives: Device: Modified High-flow nasal cannula |
| Nasal cnnnula therapy | Active comparator | Patients undergoing bronchoscopy are given nasal cannula oxygen therapy all the time. Receives: Device: nasal cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
the proportion of patients SpO2 < 90% during bronchoscopy
Measured: 1 hour
Secondary outcomes (1)
the operation time
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bronchoscopy,OxygenStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 812 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haichao Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Haichao Li, Beijing Chao Yang Hospital
- Investigators
- Bing Sun, MD, Principal investigator, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02606188
- Sponsor's protocol ID
- 2015-ke-091
- Status last verified
- Aug 2020
- First submitted
- 14 Nov 2015
- Last updated
- 19 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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 22666567Diab 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.
PubMed 25478241Wang R, Li HC, Li XY, Tang X, Chu HW, Yuan X, Tong ZH, Sun B. Modified high-flow nasal cannula oxygen therapy versus conventional oxygen therapy in patients undergoing bronchoscopy: a randomized clinical trial. BMC Pulm Med. 2021 Nov 14;21(1):367. doi: 10.1186/s12890-021-01744-8.
PubMed 34775948
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified High-flow Nasal Cannula Oxygen in Patients Undergoing Bronchoscopy.
- ClinicalTrials.gov ID
- NCT02606188
- Acronym / sponsor ID
- 2015-ke-091
- Conditions
- Bronchoscopy,Oxygen
- Keywords
- Modified High-flow nasal cannula, Bronchoscopy, Oxygen therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 812 participants (actual)
- Lead sponsor
- Haichao LiUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 17 Nov 2015 (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.
The purpose of this study is to determine whether the Modified High-flow nasal cannula is effective in the oxygen of the patients undergoing bronchoscopy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified High-flow nasal cannula therapy | Active comparator | Device: Modified High-flow nasal cannulaPatients undergoing bronchoscopy are given Modified High-flow nasal cannula oxygen therapy all the time. |
| Nasal cnnnula therapy | Active comparator | Device: nasal cannulaPatients undergoing bronchoscopy are given nasal cannula oxygen therapy all the time. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age more than 18 years old;
- need for bronchoscopy for diagnosis purpose.
Key exclusion criteria (3 listed)
- peripheral arterial pulse oximetry was < 90%
- platelet count < 60 × 109/L;
- nasopharyngeal obstruction or blockage.
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 |
|---|---|---|
| Modified High-flow nasal cannulaModified High-flow nasal cannula | Device | Modified High-flow nasal cannula therapy |
| nasal cannulaConventional oxygen therap | Device | Nasal cnnnula therapy |
Primary outcome
the proportion of patients SpO2 < 90% during bronchoscopy
Time frame: 1 hour
1 secondary outcome
the operation time
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2020.
- Results publication: 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.
- Results publication: PubMed 25478241Diab 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.
- Derived from this study: PubMed 34775948Wang R, Li HC, Li XY, Tang X, Chu HW, Yuan X, Tong ZH, Sun B. Modified high-flow nasal cannula oxygen therapy versus conventional oxygen therapy in patients undergoing bronchoscopy: a randomized clinical trial. BMC Pulm Med. 2021 Nov 14;21(1):367. doi: 10.1186/s12890-021-01744-8.
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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.
Bing Sun, MD principal investigator
Beijing Chao Yang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified High-flow nasal cannula and nasal cannula in people with Bronchoscopy,Oxygen, run by Haichao Li at 1 site in China.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 19 Aug 2020. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the proportion of patients SpO2 < 90% during bronchoscopy (time frame: 1 hour). 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 NCT02606188, which also lists 3 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 19 Aug 2020.