Mechanical VentilationHEMOSTIMNCT04680351
Evaluation of the Hemodynamic Effects of Transvenous Phrenic Stimulation
A study testing phrenic stimulation in people with Mechanical Ventilation, run by University Hospital, Angers at 3 sites in France.
Trial summary
Mechanical ventilation is a cornerstone in the management of severe forms of pneumonia, acute respiratory distress syndrome. It provides essential oxygen to patients, ventilates the lungs but also has deleterious effects like any treatment, in particular by reducing cardiac output by reducing venous return. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation
- What is being tested?
- phrenic stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 3 sitesFrance
- Study dates
- 1 Mar 2021to 1 Apr 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient included in RESCUE 3 study, interventional arm with phrenic stimulation
- Patient or family consent
Who cannot join
- Patient not affiliated or not benefiting from a social security scheme
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU Angers
Angers
Marie LEMERLE, marie.lermerle@chu-angers.fr
APHP La Pitié-Salpêtrière
Paris
Alexandra BEURTON, alexandra.beurton@aphp.fr
APHP La Pitié-Salpêtrière
Paris
Martin DRES, martin.dres@aphp.fr
About this study
Mechanical ventilation is a cornerstone in the management of severe forms of pneumonia, acute respiratory distress syndrome. It provides essential oxygen to patients, ventilates the lungs but also has deleterious effects like any treatment, in particular by reducing cardiac output by reducing venous return. Mechanical ventilation also has effects on the diaphragm: diaphragmatic dysfunction. It is explained by a prolonged inactivity of this muscle with a reduction of muscle fibers that can settle down quickly, after only a few days of mechanical ventilation. This dysfunction results in a reduction in the latter's ability to generate intrathoracic pressure necessary for ventilation, slows the withdrawal of mechanical ventilation and lengthens the duration of stay in intensive care unit. To reduce this dysfunction, phrenic stimulation has been proposed as an alternative to remuscler the diaphragm thanks to electrodes located on a central venous catheter, also used to deliver the usual therapies in intensive care unit.
The HEMOSTIM study is interested in the effects of phrenic stimulation on regional ventilation, cardiac output and cerebral perfusion: investigator hypothesize that diaphragmatic stimulation allows an improvement of these parameters.
- Conditions
- Mechanical Ventilation
- Being tested
- phrenic stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phrenic stimulationProcedure or surgery
measurements of the hemodynamic effects of phrenic stimulation
| Study group | Role | What they receive |
|---|---|---|
| phrenic stimulation | Experimental | Not described Receives: Procedure: phrenic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement of integral time speed by cardiac transthoracic ultrasound
to assess the effects of phrenic stimulation on cardiac output
Measured: 1 minute
Measurement of increased venous return gradient in percentage (variation between the value before phrenic stimulation and the value after phrenic stimulation)
To specify the mechanisms of the effect of phrenic stimulation on cardiac output
Measured: 1 minute
Secondary outcomes (2)
variation in ventilation distribution before and after phrenic stimulation measured in electrical impedance tomography
To assess the effects of diaphragmatic stimulation on ventilation and pulmonary recruitment measured in electrical impedance tomography
Measured: 1 minute
Measurement of diaphragmatic stimulation on cerebral oxygenation evaluated by the Near infrared spectrometry technique
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start1 Mar 2021 (estimated)
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04680351
- Sponsor's protocol ID
- 49RC20_0270
- Acronym
- HEMOSTIM
- Status last verified
- Dec 2020
- First submitted
- 8 Dec 2020
- Last updated
- 23 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Hemodynamic Effects of Transvenous Phrenic Stimulation
- ClinicalTrials.gov ID
- NCT04680351
- Acronym / sponsor ID
- HEMOSTIM / 49RC20_0270
- Conditions
- Mechanical Ventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 23 Dec 2020 (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.
Mechanical ventilation is a cornerstone in the management of severe forms of pneumonia, acute respiratory distress syndrome. It provides essential oxygen to patients, ventilates the lungs but also has deleterious effects like any treatment, in particular by reducing cardiac output by reducing venous return. Mechanical ventilation also has effects on the diaphragm: diaphragmatic dysfunction. It is explained by a prolonged inactivity of this muscle with a reduction of muscle fibers that can settle down quickly, after only a few days of mechanical ventilation. This dysfunction results in a reduction in the latter's ability to generate intrathoracic pressure necessary for ventilation, slows the withdrawal of mechanical ventilation and lengthens the duration of stay in intensive care unit. To reduce this dysfunction, phrenic stimulation has been proposed as an alternative to remuscler the diaphragm thanks to electrodes located on a central venous catheter, also used to deliver the usual therapies in intensive care unit.
The HEMOSTIM study is interested in the effects of phrenic stimulation on regional ventilation, cardiac output and cerebral perfusion: investigator hypothesize that diaphragmatic stimulation allows an improvement of these parameters.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| phrenic stimulation | Experimental | Procedure: phrenic stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient included in RESCUE 3 study, interventional arm with phrenic stimulation
- Patient or family consent
Key exclusion criteria (1 listed)
- Patient not affiliated or not benefiting from a social security scheme
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 |
|---|---|---|
| phrenic stimulationmeasurements of the hemodynamic effects of phrenic stimulation | Procedure or surgery | phrenic stimulation |
Primary outcome
measurement of integral time speed by cardiac transthoracic ultrasound
Time frame: 1 minute
to assess the effects of phrenic stimulation on cardiac output
Measurement of increased venous return gradient in percentage (variation between the value before phrenic stimulation and the value after phrenic stimulation)
Time frame: 1 minute
To specify the mechanisms of the effect of phrenic stimulation on cardiac output
2 secondary outcomes
variation in ventilation distribution before and after phrenic stimulation measured in electrical impedance tomography
Time frame: 1 minute
Measurement of diaphragmatic stimulation on cerebral oxygenation evaluated by the Near infrared spectrometry technique
Time frame: 1 minute
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2020.
- 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing phrenic stimulation in people with Mechanical Ventilation, run by University Hospital, Angers at 3 sites in France.
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 1 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 23 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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 Marie LEMERLE (0241353637, marie.lemerle@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurement of integral time speed by cardiac transthoracic ultrasound (time frame: 1 minute). The study lists 2 primary outcomes in all. 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 23 Dec 2020.