HypoxiaHFNONCT05298319
The 90% Effective Flow of High Flow Nasal Oxygenation (HFNO) During Sedated Bronchoscopy
A study testing high flow nasal cannula in people with Hypoxia, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
Patients undergoing sedated bronchoscopy were randomized into six groups (10 Liters/minute [L/min], 20 L/min, 30 L/min, 40 L/min, 50 L/min, 60 L/min). The primary outcome was the incidence of hypoxemia. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypoxia
- What is being tested?
- high flow nasal cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2022to 31 Aug 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) undergoing sedated bronchoscopy
- (2) 18 to 70 years of age;
- (3) American Society of Anaesthesiologists (ASA) class: I-III
Who cannot join
- (1) severe cardiac disease, including aortic stenosis, mitral stenosis, hemodynamic instability caused by severe arrhythmia, and acute myocardial infarction or cardiac surgery within the last 6 months;
- (2) severe hypoxemia (SpO2 < 90% without oxygen supply on admission), caused by interstitial lung disease, end-stage chronic obstructive pulmonary disease (COPD) or other diseases;
- (3) upper respiratory tract infection or lung infection;
- (4) refusal to participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The 90% Effective Flow of High Flow Nasal Oxygenation During Deeply Sedated Bronchoscopy
Patients undergoing sedated bronchoscopy were randomized into six groups (10 Liters/minute [L/min], 20 L/min, 30 L/min, 40 L/min, 50 L/min, 60 L/min). The primary outcome was the incidence of hypoxemia.
Read the detailed description
It's a double-blind, randomized trial. The patients'demographic information, such as sex, weight, height, smoking status, present illness and history of past illness, were collected. After successful peripheral intravenous access, all patients, before sedation, received 20 min nebulization with lidocaine via a nebuliser facemask. The basic oxygen saturation, heart rate, and blood pressure of the patients were recorded by the investigators.Patients in the HFNO group received humidified oxygen at different rates via a high-flow nasal cannula (AIRVO2, New Zealand). After sedation with propofol and sufentanil, continuous electrocardiography and pulse oximetry were recorded, and the blood pressure of the patients was monitored throughout the procedure. . After bronchoscopy, patients were transferred to the post anesthesia care unit (PACU) if their vital signs were stable.
- Conditions
- Hypoxia
- Being tested
- high flow nasal cannula
- Keywords
- high flow nasal oxygenation, hypoxemia, bronchoscopy, effective flow
- 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 cannulaDevice
The patients were randomized into 6 groups, each group received different flow of oxygen, to observe the incidence of hypoxemia between different groups.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 10 L/min of oxygen flow Receives: Device: high flow nasal cannula |
| Group 2 | Experimental | 20 L/min of oxygen flow Receives: Device: high flow nasal cannula |
| Group 3 | Experimental | 30 L/min of oxygen flow Receives: Device: high flow nasal cannula |
| Group 4 | Experimental | 40 L/min of oxygen flow Receives: Device: high flow nasal cannula |
| Group 5 | Experimental | 50 L/min of oxygen flow Receives: Device: high flow nasal cannula |
| Group 6 | Experimental | 60 L/min of oxygen flow Receives: Device: high flow nasal cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of hypoxemia
hypoxemia was defined as SpO2 < 90%
Measured: during bronchoscopy
Secondary outcomes (3)
jaw thrust maneuver
percentage of jaw thrust maneuver
Measured: during bronchoscopy
increase of flow rate
percentage of increase of flow rate
Measured: during bronchoscopy
bag-mask ventilation
percentage of bag-mask ventilation
Measured: during bronchoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start1 Apr 2022
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypoxiaStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen Zhang, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05298319
- Sponsor's protocol ID
- Zhejiang Cancer Hospital
- Acronym
- HFNO
- Status last verified
- Nov 2023
- First submitted
- 28 Feb 2022
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang W, Yuan X, Shen Y, Wang J, Xie K, Chen X. Optimal flow of high-flow nasal cannula oxygenation to prevent desaturation during sedation for bronchoscopy: a randomized controlled study. Ther Adv Respir Dis. 2024 Jan-Dec;18:17534666241246637. doi: 10.1177/17534666241246637.
PubMed 38659187
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The 90% Effective Flow of High Flow Nasal Oxygenation During Deeply Sedated Bronchoscopy
- ClinicalTrials.gov ID
- NCT05298319
- Acronym / sponsor ID
- HFNO / Zhejiang Cancer Hospital
- Conditions
- Hypoxia
- Keywords
- high flow nasal oxygenation, hypoxemia, bronchoscopy, effective flow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 28 Mar 2022 (actual)
- 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.
Patients undergoing sedated bronchoscopy were randomized into six groups (10 Liters/minute [L/min], 20 L/min, 30 L/min, 40 L/min, 50 L/min, 60 L/min). The primary outcome was the incidence of hypoxemia.
Detailed description
It's a double-blind, randomized trial. The patients'demographic information, such as sex, weight, height, smoking status, present illness and history of past illness, were collected. After successful peripheral intravenous access, all patients, before sedation, received 20 min nebulization with lidocaine via a nebuliser facemask. The basic oxygen saturation, heart rate, and blood pressure of the patients were recorded by the investigators.Patients in the HFNO group received humidified oxygen at different rates via a high-flow nasal cannula (AIRVO2, New Zealand). After sedation with propofol and sufentanil, continuous electrocardiography and pulse oximetry were recorded, and the blood pressure of the patients was monitored throughout the procedure. . After bronchoscopy, patients were transferred to the post anesthesia care unit (PACU) if their vital signs were stable.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: high flow nasal cannula10 L/min of oxygen flow |
| Group 2 | Experimental | Device: high flow nasal cannula20 L/min of oxygen flow |
| Group 3 | Experimental | Device: high flow nasal cannula30 L/min of oxygen flow |
| Group 4 | Experimental | Device: high flow nasal cannula40 L/min of oxygen flow |
| Group 5 | Experimental | Device: high flow nasal cannula50 L/min of oxygen flow |
| Group 6 | Experimental | Device: high flow nasal cannula60 L/min of oxygen flow |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- (1) undergoing sedated bronchoscopy
- (2) 18 to 70 years of age;
- (3) American Society of Anaesthesiologists (ASA) class: I-III
Key exclusion criteria (4 listed)
- (1) severe cardiac disease, including aortic stenosis, mitral stenosis, hemodynamic instability caused by severe arrhythmia, and acute myocardial infarction or cardiac surgery within the last 6 months;
- (2) severe hypoxemia (SpO2 < 90% without oxygen supply on admission), caused by interstitial lung disease, end-stage chronic obstructive pulmonary disease (COPD) or other diseases;
- (3) upper respiratory tract infection or lung infection;
- (4) refusal to participate in this study.
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 cannulaThe patients were randomized into 6 groups, each group received different flow of oxygen, to observe the incidence of hypoxemia between different groups. | Device | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6 |
Primary outcome
the incidence of hypoxemia
Time frame: during bronchoscopy
hypoxemia was defined as SpO2 < 90%
3 secondary outcomes
jaw thrust maneuver
Time frame: during bronchoscopy
increase of flow rate
Time frame: during bronchoscopy
bag-mask ventilation
Time frame: during bronchoscopy
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 29 Nov 2023.
- Derived from this study: PubMed 38659187Zhang W, Yuan X, Shen Y, Wang J, Xie K, Chen X. Optimal flow of high-flow nasal cannula oxygenation to prevent desaturation during sedation for bronchoscopy: a randomized controlled study. Ther Adv Respir Dis. 2024 Jan-Dec;18:17534666241246637. doi: 10.1177/17534666241246637.
- Individual participant dataSharing planned: No
Related trials for Hypoxia
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
Enrolling by invitation
Extubation Safety Via Microstream EtCO₂ (IPI) Monitoring
Hypoxemia
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
Active, not recruitingPhase 3
A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012)
Carcinoma, Renal Cell
RecruitingObservational study
Comparison of Pulse Oximetry (SpO2) With Different Oximeters and Arterial Saturation (SaO2): Oxygap2 Study
Respiratory Failure, Hypoxemia
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.
The record lists no contact. Use the official record to reach the sponsor.
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 cannula in people with Hypoxia, run by Zhejiang Cancer Hospital 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 3 inclusion and 4 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 29 Nov 2023. 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 incidence of hypoxemia (time frame: during bronchoscopy). 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 NCT05298319, which also lists 1 linked publication.
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 29 Nov 2023.