HealthyNCT06384027
Effects of Non-invasive Ventilation on Function Diaphragmatic and Caval Distension
A study testing Non-invasive ventilation in people with Healthy, run by Federal University of Paraíba at 1 site in Brazil.
Trial summary
Introduction: Understanding how the applicability of non-invasive ventilation can directly affect the anatomy and diaphragmatic function, as well as the opening diameter of the inferior vena cava in healthy individuals is fundamental to knowing how this therapy can interfere with treatment results. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Non-invasive ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteBrazil
- Study dates
- 24 Apr 2024to 21 Jul 2024
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers;
- Age equal to or over 18 years old and under 50 years old.
Who cannot join
- Cardiopathy;
- Pneumopathy;
- Participants who develop any disabling condition that prevents completion of the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Effects of Non-invasive Ventilation on Muscle Function Diaphragmatic and Inferior Vena Cava Distension in People Healthy
Introduction: Understanding how the applicability of non-invasive ventilation can directly affect the anatomy and diaphragmatic function, as well as the opening diameter of the inferior vena cava in healthy individuals is fundamental to knowing how this therapy can interfere with treatment results. Objective: Identify the acute effects of PEEP and ventilatory support pressure on thickening fraction, diaphragmatic mobility and vena cava distension in healthy people. Methods: This is a crossover, randomized study, blinded to the evaluator and the researcher responsible for the statistical analysis. Volunteers will undergo a NIV session, randomized into groups: CPAP, Bi-level and spontaneous breathing, without NIV support (control). The outcomes evaluated will be diaphragmatic ultrasound and inferior vena cava distensibility. The CPAP levels will be: 5, 10 and 15 cmH2O after 5 minutes of use and in the Bi-level group we will maintain the PEEP value at 5cmH2O and modify the pressure support values to the values: 5, 7 and 10 cmH2O pressure support, with all outcomes also being assessed after 5 minutes. Participants will remain in a supine position, with the right upper limb positioned behind the head, throughout the protocol and all measurements will be collected in the inspiratory and expiratory phases with volumes basal currents. For statistical analysis, intention-to-treat analysis will be employed and groups will be compared using Student's t-test, for continuous variables, or chi-square, for categorical variables. ANOVA split-plot, repeated measures for primary occurrences. Analyzes of covariance to identify differences between groups using baseline scores as covariates. Effect sizes and confidence intervals will be calculated using eta squared (η²). Expected results: Elucidate the effects of different blood pressure levels on diaphragmatic function and inferior vena cava distension.
- Conditions
- Healthy
- Being tested
- Non-invasive ventilation
- Keywords
- Non-invasive ventilation, Diaphragmatic ultrasound, Inferior vena cava
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive ventilationOther
Ventilation support that does not require an artificial airway that aims to reverse respiratory muscle fatigue and decrease the work of the respiratory muscles, maintaining a positive pressure, allows alveolar recruitment, preventing atelectasis and airway collapse. NIV can be administered using continuous positive airway pressure (CPAP) or two levels of airway pressure (Bi-level).
| Study group | Role | What they receive |
|---|---|---|
| Spontaneous breathing | No intervention | The volunteer will remain lying down for a period of 5 minutes in spontaneous breathing and after this period the diaphragmatic and inferior vena cava ultrasound outcomes will be evaluated. |
| CPAP | Active comparator | When using CPAP, these same outcomes will be evaluated at three different PEEP levels, namely: 5, 10 and 15 cmH2O after 5 minutes of use. Receives: Other: Non-invasive ventilation |
| Bilevel | Active comparator | During the use of Bi-level, we will maintain the PEEP value at 5cmH2O and modify the pressure support (PS) ventilation values, establishing the following values: 5, 7 and 10 cmH2O of PS, with all outcomes also being evaluated at the same time. end of 5 minutes. Receives: Other: Non-invasive ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragmatic thickening fraction
Diaphragmatic ultrasound is a useful technique for evaluating diaphragm function. To evaluate atrophy, it will be necessary to evaluate the thickening fraction (EF). A high-frequency linear transducer (7-13 MHz) will be placed over the ZA, between the eighth and ninth intercostal space, usually 0.5-2.0 cm below the costophrenic angle, between the anterior axillary line and the axillary line. medium, at a depth of 1.5 to 3 cm. The thickening fraction will be measured from the center of the pleural line to the center of the peritoneal line, at the end of expiration (Tdi-exp) and then at the end of inspiration (Tdi-insp), in modes B and M. calculated as follows:
FE = Tdi-insp - Tdi-exp × 100 Tdi-exp
Measured: The assessment will be carried out after 5 minutes of RE, CPAP or Bilevel
Secondary outcomes (1)
Diaphragmatic mobility
Diaphragmatic mobility (MD) is measured by visualizing the hemidiaphragms through the anterior subcostal route with the convex probe below the costal margin between the midclavicular line and the anterior axillary line, the ultrasound shows the diaphragm as a deep curved structure that separates the thorax from the abdomen. To quantify mobility and diaphragmatic thickening objectively, it is necessary to evaluate at least three images and calculate the average of the MD and FE values. During the assessments, we visualize the MD during calm breathing.
Measured: The assessment will be carried out after 5 minutes of RE, CPAP or Bilevel
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start24 Apr 2024
- Primary completion21 Jul 2024
- Study completion21 Jul 2024
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 HealthyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a crossover, randomized study, blinded
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Paraíba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eduardo Eriko Tenório de França, Federal University of Paraíba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06384027
- Sponsor's protocol ID
- VNI_USG_2024
- Status last verified
- Sep 2024
- First submitted
- 17 Apr 2024
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jansen D, Jonkman AH, Vries HJ, Wennen M, Elshof J, Hoofs MA, van den Berg M, Man AME, Keijzer C, Scheffer GJ, van der Hoeven JG, Girbes A, Tuinman PR, Marcus JT, Ottenheijm CAC, Heunks L. Positive end-expiratory pressure affects geometry and function of the human diaphragm. J Appl Physiol (1985). 2021 Oct 1;131(4):1328-1339. doi: 10.1152/japplphysiol.00184.2021. Epub 2021 Sep 2.
PubMed 34473571
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Non-invasive Ventilation on Muscle Function Diaphragmatic and Inferior Vena Cava Distension in People Healthy
- ClinicalTrials.gov ID
- NCT06384027
- Acronym / sponsor ID
- VNI_USG_2024
- Conditions
- Healthy
- Keywords
- Non-invasive ventilation, Diaphragmatic ultrasound, Inferior vena cava
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Federal University of ParaíbaUniversity, hospital or other
- Study start
- 24 Apr 2024 (actual)
- Primary completion
- 21 Jul 2024 (actual)
- Study completion
- 21 Jul 2024 (actual)
- First posted
- 25 Apr 2024 (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.
Introduction: Understanding how the applicability of non-invasive ventilation can directly affect the anatomy and diaphragmatic function, as well as the opening diameter of the inferior vena cava in healthy individuals is fundamental to knowing how this therapy can interfere with treatment results. Objective: Identify the acute effects of PEEP and ventilatory support pressure on thickening fraction, diaphragmatic mobility and vena cava distension in healthy people. Methods: This is a crossover, randomized study, blinded to the evaluator and the researcher responsible for the statistical analysis. Volunteers will undergo a NIV session, randomized into groups: CPAP, Bi-level and spontaneous breathing, without NIV support (control). The outcomes evaluated will be diaphragmatic ultrasound and inferior vena cava distensibility. The CPAP levels will be: 5, 10 and 15 cmH2O after 5 minutes of use and in the Bi-level group we will maintain the PEEP value at 5cmH2O and modify the pressure support values to the values: 5, 7 and 10 cmH2O pressure support, with all outcomes also being assessed after 5 minutes. Participants will remain in a supine position, with the right upper limb positioned behind the head, throughout the protocol and all measurements will be collected in the inspiratory and expiratory phases with volumes basal currents. For statistical analysis, intention-to-treat analysis will be employed and groups will be compared using Student's t-test, for continuous variables, or chi-square, for categorical variables. ANOVA split-plot, repeated measures for primary occurrences. Analyzes of covariance to identify differences between groups using baseline scores as covariates. Effect sizes and confidence intervals will be calculated using eta squared (η²). Expected results: Elucidate the effects of different blood pressure levels on diaphragmatic function and inferior vena cava distension.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- This is a crossover, randomized study, blinded
| Arm | Type | Receives |
|---|---|---|
| Spontaneous breathing | No intervention | –The volunteer will remain lying down for a period of 5 minutes in spontaneous breathing and after this period the diaphragmatic and inferior vena cava ultrasound outcomes will be evaluated. |
| CPAP | Active comparator | Other: Non-invasive ventilationWhen using CPAP, these same outcomes will be evaluated at three different PEEP levels, namely: 5, 10 and 15 cmH2O after 5 minutes of use. |
| Bilevel | Active comparator | Other: Non-invasive ventilationDuring the use of Bi-level, we will maintain the PEEP value at 5cmH2O and modify the pressure support (PS) ventilation values, establishing the following values: 5, 7 and 10 cmH2O of PS, with all outcomes also being evaluated at the same time. end of 5 minutes. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy volunteers;
- Age equal to or over 18 years old and under 50 years old.
Key exclusion criteria (3 listed)
- Cardiopathy;
- Pneumopathy;
- Participants who develop any disabling condition that prevents completion of the protocol.
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 |
|---|---|---|
| Non-invasive ventilationVentilation support that does not require an artificial airway that aims to reverse respiratory muscle fatigue and decrease the work of the respiratory muscles, maintaining a positive pressure, allows alveolar recruitment, preventing atelectasis and airway collapse. NIV can be administered using continuous positive airway pressure (CPAP) or two levels of airway pressure (Bi-level). | Other | Bilevel, CPAP |
Primary outcome
Diaphragmatic thickening fraction
Time frame: The assessment will be carried out after 5 minutes of RE, CPAP or Bilevel
Diaphragmatic ultrasound is a useful technique for evaluating diaphragm function. To evaluate atrophy, it will be necessary to evaluate the thickening fraction (EF). A high-frequency linear transducer (7-13 MHz) will be placed over the ZA, between the eighth and ninth intercostal space, usually 0.5-2.0 cm below the costophrenic angle, between the anterior axillary line and the axillary line. medium, at a depth of 1.5 to 3 cm. The thickening fraction will be measured from the center of the pleural line to the center of the peritoneal line, at the end of expiration (Tdi-exp) and then at the end of inspiration (Tdi-insp), in modes B and M. calculated as follows: FE = Tdi-insp - Tdi-exp × 100 Tdi-exp
1 secondary outcome
Diaphragmatic mobility
Time frame: The assessment will be carried out after 5 minutes of RE, CPAP or Bilevel
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 25 Sep 2024.
- Results publication: PubMed 34473571Jansen D, Jonkman AH, Vries HJ, Wennen M, Elshof J, Hoofs MA, van den Berg M, Man AME, Keijzer C, Scheffer GJ, van der Hoeven JG, Girbes A, Tuinman PR, Marcus JT, Ottenheijm CAC, Heunks L. Positive end-expiratory pressure affects geometry and function of the human diaphragm. J Appl Physiol (1985). 2021 Oct 1;131(4):1328-1339. doi: 10.1152/japplphysiol.00184.2021. Epub 2021 Sep 2.
- Individual participant dataSharing planned: No
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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 Non-invasive ventilation in people with Healthy, run by Federal University of Paraíba at 1 site in Brazil.
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 25 Sep 2024. 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 Brazil. 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?
Diaphragmatic thickening fraction (time frame: The assessment will be carried out after 5 minutes of RE, CPAP or Bilevel). 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 NCT06384027, 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 25 Sep 2024.