Acute Viral BronchitisHIVINCT04750408
NHF vs. COT in Hypoxemic Pandemic Viral Illness
A study testing Standard oxygen and Nasal high-flow in people with Acute Viral Bronchitis and Hypoxemic Respiratory Failure, run by Jens Bräunlich at 1 site in Germany.
Trial summary
The study compares oxygen and NHF in patients with acute viral illness. The duration will be 72h. After them physiological parameters and the outcome will be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Acute Viral Bronchitis, Hypoxemic Respiratory Failure, Hypercapnic Respiratory Failure
- What is being tested?
- Standard oxygen and Nasal high-flow
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteGermany
- Study dates
- 22 Jan 2021to 22 Jun 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- acute hyperemic viral illness
- acute hyperemic or hypercapnia respiratory failure
Who cannot join
- intubation criteria
- indication for NIV therapy
- influences of primary endpoint (rip fracture, lung embolism)
- tracheostomy
- other interventional trials
- noncompliance
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Klinikum Emden
Emden, 26721
Jens Bräunlich, MD, +494921981598, highflow@web.de
About this study
Official title: Clinical Effects of Nasal High-flow Compared to Oxygen in Acute Viral Illness
The study compares oxygen and NHF in patients with acute viral illness. The duration will be 72h. After them physiological parameters and the outcome will be evaluated.
- Being tested
- Standard oxygen, Nasal high-flow
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard oxygenDevice
Also called COT
COT describes the application of low-flow oxygen in any way (Hudson mask, nasal prongs,...).
Nasal high-flowDevice
Also called NHF
F is combination of room air supplemented with oxygen can be better patients. This gas mixture will be provided to the patient with a specialized nasal prong.
| Study group | Role | What they receive |
|---|---|---|
| Oxygen use | Active comparator | Patients will use standard oxygen via face mask of nasal prongs as usual care. Receives: Device: Standard oxygen |
| NHF use | Experimental | Patients will use NHF instead of oxygen. Oxygen will be supplemented via the NHF flow. Receives: Device: Nasal high-flow |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rox index
(SpO2/FiO2)/RR = index without a unit, mean Rox-index in the two groups, comparison between the groups (significant differences), physiological parameter, to assess differences between the two groups
Measured: 72 hours
Secondary outcomes (4)
paCO2 in mmHg
physiological parameter, to assess differences between the two groups
Measured: 72 hours
pH
physiological parameter, to assess differences between the two groups
Measured: 72 hours
escalation of therapy
use of noninvasive ventilation, intubation, to assess differences between the two groups
Measured: 72 hours
paO2 in mmHg
physiological parameter, to assess differences between the two groups
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start22 Jan 2021
- Primary completion22 Jun 2022 (estimated)
- Study completion22 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Viral BronchitisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jens Bräunlich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jens Bräunlich, Klinikum Emden
- Investigators
- Jens Bräunlich, MD, Study chair, chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04750408
- Sponsor's protocol ID
- 01
- Acronym
- HIVI
- Status last verified
- Mar 2022
- First submitted
- 21 Jan 2021
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: original/ raw data
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effects of Nasal High-flow Compared to Oxygen in Acute Viral Illness
- ClinicalTrials.gov ID
- NCT04750408
- Acronym / sponsor ID
- HIVI / 01
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Jens BräunlichUniversity, hospital or other
- Study start
- 22 Jan 2021 (actual)
- Primary completion
- 22 Jun 2022 (estimated)
- Study completion
- 22 Jun 2022 (estimated)
- First posted
- 11 Feb 2021 (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.
The study compares oxygen and NHF in patients with acute viral illness. The duration will be 72h. After them physiological parameters and the outcome will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxygen use | Active comparator | Device: Standard oxygenPatients will use standard oxygen via face mask of nasal prongs as usual care. |
| NHF use | Experimental | Device: Nasal high-flowPatients will use NHF instead of oxygen. Oxygen will be supplemented via the NHF flow. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- acute hyperemic viral illness
- acute hyperemic or hypercapnia respiratory failure
Key exclusion criteria (6 listed)
- intubation criteria
- indication for NIV therapy
- influences of primary endpoint (rip fracture, lung embolism)
- tracheostomy
- other interventional trials
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 |
|---|---|---|
| Standard oxygenAlso: COTCOT describes the application of low-flow oxygen in any way (Hudson mask, nasal prongs,...). | Device | Oxygen use |
| Nasal high-flowAlso: NHFF is combination of room air supplemented with oxygen can be better patients. This gas mixture will be provided to the patient with a specialized nasal prong. | Device | NHF use |
Primary outcome
Rox index
Time frame: 72 hours
(SpO2/FiO2)/RR = index without a unit, mean Rox-index in the two groups, comparison between the groups (significant differences), physiological parameter, to assess differences between the two groups
4 secondary outcomes
paCO2 in mmHg
Time frame: 72 hours
pH
Time frame: 72 hours
escalation of therapy
Time frame: 72 hours
paO2 in mmHg
Time frame: 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Individual participant dataSharing planned: Yes. original/ raw data
Related trials for Acute Viral Bronchitis
Recruiting
Respiratory Physiotherapy and Hospitalization in Infants With Bronchiolitis
Acute Viral Bronchiolitis
Not yet recruitingObservational study
Internal Jugular Vein Respiratory Variability as a Marker of Disease Severity in Infant Bronchiolitis
Acute Bronchiolitis, Viral Bronchiolitis
Active, not recruitingObservational study
Effectiveness of Immunization in Preventing Severe Acute Respiratory Infection RSV in Children Under 6 Months in Bogotá
Respiratory Syncytial Virus Infections, Severe Acute Respiratory Infection
Not yet recruitingObservational study
Risk Factors and Severity of Bronchiolitis in Hospitalized Children at Assiut University Hospital
Bronchiolitis, Acute Bronchiolitis
Not yet recruitingObservational study
Gut Microbiome and Immune Response in Severe RSV Infection in Vietnamese Infants
Respiratory Syncytial Virus Infection, Bronchiolitis
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.
Jens Bräunlich, MD study chair
chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard oxygen and Nasal high-flow in people with Acute Viral Bronchitis and Hypoxemic Respiratory Failure, run by Jens Bräunlich at 1 site in Germany.
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 6 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 31 Mar 2022. 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 Germany. 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 Jens Bräunlich, MD (+494921981598, highflow@web.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rox index (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Mar 2022; AzTrials last refreshed its copy on 6 Nov 2026.