Intensive Care PatientsPVP-StepPEPNCT05026255
Assessment of Preload Dependency Via Measurement of Peripheral Venous Pressure During an Alveolar Recruitment Manoeuvre
A study testing alveolar recruitment manoeuvre by pressure step in people with Intensive Care Patients, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
Assessment of preload dependency via measurement of peripheral venous pressure during an alveolar recruitment manoeuvre. Prospective multicentre open-label study of mechanically ventilated intensive care patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Patients
- What is being tested?
- alveolar recruitment manoeuvre by pressure step
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- 8 Dec 2021to 29 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years or older, for whom the trusted person designated by the patient or, failing that, a relative has read and signed the consent form for participation in the study
- Patient hospitalised in intensive care, under sedation and controlled mechanical ventilation
- Equipped with a central venous line in the superior vena cava territory and an arterial catheter.
- Whose state of health justifies vascular filling
Who cannot join
- Patient under legal protection, guardianship or curatorship
- Pregnant or breastfeeding woman
- Patient not affiliated to the French social security system
- Contraindication to the realization of an alveolar recruitment maneuver
Trial locations and contacts
1 site in 1 country.
About this study
Assessment of preload dependency via measurement of peripheral venous pressure during an alveolar recruitment manoeuvre.
Prospective multicentre open-label study of mechanically ventilated intensive care patients.
- Conditions
- Intensive Care Patients
- Being tested
- alveolar recruitment manoeuvre by pressure step
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alveolar recruitment manoeuvre by pressure stepProcedure or surgery
The application of alveolar recruitment manoeuvres consists of transiently increasing alveolar pressure in order to re-open collapsed alveolar territories and to re-ventilate poorly ventilated or non-ventilated lung areas.
| Study group | Role | What they receive |
|---|---|---|
| mechanically ventilated intensive care patients. | Experimental | Observational data collected for patients in intensive care under mechanical ventilation. Receives: Procedure: alveolar recruitment manoeuvre by pressure step |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome measure
The correlation between the pairs of values of CVP and PVP during an alveolar recruitment manoeuvre will be evaluated by Pearson's coefficient or Spearman's coefficient if the distribution of the values is not parametric. The coefficient of determination r² will be calculated by linear regression between the 2 variables. Finally, the agreement between the two measurements will be evaluated by the Bland-Altman method: the Bland-Altman graph will be provided and the 95% agreement limits will be calculated (+/- 1.96 SD, SD being the standard deviation of the difference between the measurements).
Measured: through study completion, an average of 12 hours
Secondary outcomes (1)
Secondary outcome measure
Predictive value of the evolution of PVP during the recruitment manoeuvre: the ROC curve (receiver-operating characteristic) will be performed by logistic regression. The area under the ROC curve will be given as well as the sensitivity, specificity and negative and positive predictive values (Younden index will be used to determine the optimal threshold of PVP).
Measured: through study completion, an average of 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start8 Dec 2021
- Primary completion29 Aug 2022
- Study completion29 Aug 2022
Why it stopped: insufficient recruitment due to COVID 19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care PatientsStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective multicentre open-label study of mechanically ventilated intensive care patients.
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05026255
- Sponsor's protocol ID
- 2020-A02683-36
- Acronym
- PVP-StepPEP
- Status last verified
- Jun 2024
- First submitted
- 16 Aug 2021
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Preload Dependency Via Measurement of Peripheral Venous Pressure During an Alveolar Recruitment Manoeuvre
- ClinicalTrials.gov ID
- NCT05026255
- Acronym / sponsor ID
- PVP-StepPEP / 2020-A02683-36
- Conditions
- Intensive Care Patients
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient recruitment due to COVID 19
- Enrolment
- 21 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 8 Dec 2021 (actual)
- Primary completion
- 29 Aug 2022 (actual)
- Study completion
- 29 Aug 2022 (actual)
- First posted
- 30 Aug 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.
Assessment of preload dependency via measurement of peripheral venous pressure during an alveolar recruitment manoeuvre.
Prospective multicentre open-label study of mechanically ventilated intensive care patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective multicentre open-label study of mechanically ventilated intensive care patients.
| Arm | Type | Receives |
|---|---|---|
| mechanically ventilated intensive care patients. | Experimental | Procedure: alveolar recruitment manoeuvre by pressure stepObservational data collected for patients in intensive care under mechanical ventilation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18 years or older, for whom the trusted person designated by the patient or, failing that, a relative has read and signed the consent form for participation in the study
- Patient hospitalised in intensive care, under sedation and controlled mechanical ventilation
- Equipped with a central venous line in the superior vena cava territory and an arterial catheter.
- Whose state of health justifies vascular filling
Key exclusion criteria (4 listed)
- Patient under legal protection, guardianship or curatorship
- Pregnant or breastfeeding woman
- Patient not affiliated to the French social security system
- Contraindication to the realization of an alveolar recruitment maneuver
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 |
|---|---|---|
| alveolar recruitment manoeuvre by pressure stepThe application of alveolar recruitment manoeuvres consists of transiently increasing alveolar pressure in order to re-open collapsed alveolar territories and to re-ventilate poorly ventilated or non-ventilated lung areas. | Procedure or surgery | mechanically ventilated intensive care patients. |
Primary outcome
Primary outcome measure
Time frame: through study completion, an average of 12 hours
The correlation between the pairs of values of CVP and PVP during an alveolar recruitment manoeuvre will be evaluated by Pearson's coefficient or Spearman's coefficient if the distribution of the values is not parametric. The coefficient of determination r² will be calculated by linear regression between the 2 variables. Finally, the agreement between the two measurements will be evaluated by the Bland-Altman method: the Bland-Altman graph will be provided and the 95% agreement limits will be calculated (+/- 1.96 SD, SD being the standard deviation of the difference between the measurements).
1 secondary outcome
Secondary outcome measure
Time frame: through study completion, an average of 12 hours
Results and safety
The study was stopped early (reason given: insufficient recruitment due to COVID 19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
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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 alveolar recruitment manoeuvre by pressure step in people with Intensive Care Patients, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site 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 4 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: stopped early, as of the sponsor's last update on 1 Jul 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 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?
The study was stopped early (reason given: insufficient recruitment due to COVID 19). Results are not available in the source record.
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?
Primary outcome measure (time frame: through study completion, an average of 12 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 1 Jul 2024.