Respiratory InsufficiencySENNINCT07050147
Sonographic Evaluation of Diaphragmatic Function Under Nasal High-flow (NHF) and Non-invasive Ventilation (NIV) in Respiratory Insufficiency
A study testing Nasal high flow and NIV in people with Respiratory Insufficiency, run by Klinikum Emden at 1 site in Germany.
Trial summary
The aim of the study is to investigate the influence of respiratory support on diaphragmatic function (O2, NHF, NIV). The effects on the diaphragm, the respiratory values (FEV1, respiratory rate) and the subjective well-being of the patients during the therapy phases will be measured. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Respiratory Insufficiency
- What is being tested?
- Nasal high flow and NIV
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2019to 1 Jan 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- acute or chronic respiratory insufficiency with and/or hypercapnia,
- age > 18 years.
- tolerate respiratory support devices
- to sign a written declaration of consent
Who cannot join
- Presence of respiratory insufficiency requiring intubation,
- clinical instability,
- metabolic acidosis or alkalosis,
- Contraindication for NIV according to the S3 guideline,
- serious concomitant illnesses,
- unwillingness to co-operate
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to investigate the influence of respiratory support on diaphragmatic function (O2, NHF, NIV). The effects on the diaphragm, the respiratory values (FEV1, respiratory rate) and the subjective well-being of the patients during the therapy phases will be measured.
The primary objective of the clinical study is to investigate the differences in respiratory support with regard to the change in diaphragmatic kinetics and morphology (Tdi; TEx; Tdi, ee, Tdi, pi, ΔTdi, TFdi) as a function of respiratory rate.
For both ventilation modes, the influence on the respiratory situation, the respiratory muscle pump and adverse events will also be analysed. This is done using defined variables (FEV1, FEV1%VC, respiratory rate, frequency and type of adverse events (AEs), subjective satisfaction with the test product (Borg scale)).
- Conditions
- Respiratory Insufficiency
- Being tested
- Nasal high flow, NIV
- Keywords
- nasal high flow, NIV, diaphragm, sonography
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal high flowDevice
3 sonographic measurements after use of 30 minutes
NIVDevice
3 sonographic measurements after 30 minutes use
| Study group | Role | What they receive |
|---|---|---|
| Nasal high flow | Active comparator | Not described Receives: Device: Nasal high flow |
| NIV | Active comparator | Not described Receives: Device: NIV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sonographic measurements of diaphragm thickness
Tdi ee in mm = Diaphragm thickness is determined by measuring the distance between the diaphragmatic pleura and the diaphragm/peritoneum border at maximum expiration
Measured: after 30 minutes use
Secondary outcomes (6)
DEx
Diaphragm excursion during rest
Measured: 30 minutes
FEV1
Forced vital capacity in 1 second as % predicted
Measured: 30 min
Tiffeneau - index
FEV1%FVC in % = definition of obstruction of the airways
Measured: 30 min
Respiratory rate
counts the respiratory cycles in 1 minute
Measured: 30 min
Tdi pi
Diaphragm thickness is determined by measuring the distance between the diaphragmatic pleura and the diaphragm/peritoneum border at maximum inspiration (Tdi, pi) in mm
Measured: 30 minutes
TF di
Thickening Fraction (calculated): TFdi Diaphragm thickening fraction (change in diaphragm thickness during inspiration as a percentage [calculation from the quotient of ΔTdi and Tdi,ee])
Measured: 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start1 Jul 2019
- Primary completion1 Jan 2025
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory InsufficiencyStudies 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
- Model description
- This study is a randomised comparison of two investigational medical devices in a prospective, monocentric, randomised, physiological, open-label, cross-over study. Patients are randomised into two groups (study arms) with a randomisation ratio of 1:1.
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klinikum Emden
- Sponsor type
- University, hospital or other
- Collaborators
- University of Leipzig
- Responsible party
- Principal investigator, Jens Bräunlich, Klinikum Emden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07050147
- Sponsor's protocol ID
- 167/19-ek
- Acronym
- SENNI
- Status last verified
- Jun 2025
- First submitted
- 3 Jan 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data upon request
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sonographic Evaluation of Diaphragmatic Function Under Nasal High-flow (NHF) and Non-invasive Ventilation (NIV) in Respiratory Insufficiency
- ClinicalTrials.gov ID
- NCT07050147
- Acronym / sponsor ID
- SENNI / 167/19-ek
- Conditions
- Respiratory Insufficiency
- Keywords
- nasal high flow, NIV, diaphragm, sonography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Klinikum EmdenUniversity, hospital or other
- Collaborators
- University of Leipzig
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 3 Jul 2025 (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 aim of the study is to investigate the influence of respiratory support on diaphragmatic function (O2, NHF, NIV). The effects on the diaphragm, the respiratory values (FEV1, respiratory rate) and the subjective well-being of the patients during the therapy phases will be measured.
The primary objective of the clinical study is to investigate the differences in respiratory support with regard to the change in diaphragmatic kinetics and morphology (Tdi; TEx; Tdi, ee, Tdi, pi, ΔTdi, TFdi) as a function of respiratory rate.
For both ventilation modes, the influence on the respiratory situation, the respiratory muscle pump and adverse events will also be analysed. This is done using defined variables (FEV1, FEV1%VC, respiratory rate, frequency and type of adverse events (AEs), subjective satisfaction with the test product (Borg scale)).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a randomised comparison of two investigational medical devices in a prospective, monocentric, randomised, physiological, open-label, cross-over study. Patients are randomised into two groups (study arms) with a randomisation ratio of 1:1.
| Arm | Type | Receives |
|---|---|---|
| Nasal high flow | Active comparator | Device: Nasal high flow |
| NIV | Active comparator | Device: NIV |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- acute or chronic respiratory insufficiency with and/or hypercapnia,
- age > 18 years.
- tolerate respiratory support devices
- to sign a written declaration of consent
Key exclusion criteria (6 listed)
- Presence of respiratory insufficiency requiring intubation,
- clinical instability,
- metabolic acidosis or alkalosis,
- Contraindication for NIV according to the S3 guideline,
- serious concomitant illnesses,
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 |
|---|---|---|
| Nasal high flow3 sonographic measurements after use of 30 minutes | Device | Nasal high flow |
| NIV3 sonographic measurements after 30 minutes use | Device | NIV |
Primary outcome
Sonographic measurements of diaphragm thickness
Time frame: after 30 minutes use
Tdi ee in mm = Diaphragm thickness is determined by measuring the distance between the diaphragmatic pleura and the diaphragm/peritoneum border at maximum expiration
6 secondary outcomes
DEx
Time frame: 30 minutes
FEV1
Time frame: 30 min
Tiffeneau - index
Time frame: 30 min
Respiratory rate
Time frame: 30 min
Tdi pi
Time frame: 30 minutes
TF di
Time frame: 30 min
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 3 Jul 2025.
- Individual participant dataSharing planned: Yes. All data upon request
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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.
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 Nasal high flow and NIV in people with Respiratory Insufficiency, run by Klinikum Emden 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 4 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: finished, as of the sponsor's last update on 3 Jul 2025. 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?
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?
Sonographic measurements of diaphragm thickness (time frame: after 30 minutes use). 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 3 Jul 2025.