Positive-Pressure RespirationRHERA1NCT02805036
Comparison of the Hemodynamic Safety of Two Common Alveolar Recruitment Manoeuvres With Regard to Cardiac Output in a Surgical Intensive Care Unit
An observational study of Positive-Pressure Respiration, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Protective ventilation - combining a low tidal volume (between 6 and 8 ml/kg) and alveolar recruitment (AR) manoeuvres repeated every 30 minutes - is currently the standard of care for decreasing morbidity associated with mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Positive-Pressure Respiration
- What is being tested?
- echocardiography and Arterial oximetry
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2015to Nov 2016
- Phase
- Observational
- 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
Study population: sedated, intubated, mechanically ventilated adult patients
Who may be able to join
- All sedated, intubated, mechanically ventilated adult patients (over-18) admitted to the surgical intensive care unit and equipped with a central venous catheter and an arterial catheter.
- Good echogenicity
- Social security coverage
Who cannot join
- Pregnancy
- Cardiac arrhythmia
- Poor echogenicity
- Legal guardianship or incarceration
- Systolic blood pressure ≤90 mmHg
- Respiratory distress
- Patients admitted on an emergency basis (first 24 hours), i.e. not for elective surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Hemodynamic Safety of Two Common Alveolar Recruitment Manoeuvres With Regard to Cardiac Output in a Surgical Intensive Care Unit: a Randomized Study
Protective ventilation - combining a low tidal volume (between 6 and 8 ml/kg) and alveolar recruitment (AR) manoeuvres repeated every 30 minutes - is currently the standard of care for decreasing morbidity associated with mechanical ventilation.
In contrast, there is no consensus on the type of recruitment manoeuvre, which varies from one centre to another and from one study to another.
The investigators intend to compare two currently used AR techniques with regard to their ventilatory efficacy and hemodynamic safety:
- An end-tidal plateau at 30 cmH20 for 30 seconds.
- An end-tidal plateau at 10 cmH20 above the patient's plateau pressure for 30 seconds, without exceeding 30 cmH20.
- Conditions
- Positive-Pressure Respiration
- Being tested
- echocardiography, Arterial oximetry
- Keywords
- alveolar recruitment, stroke volume/physiology, cardiac output/physiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
echocardiographyDevice
- Prospective, simultaneous recording of the cardiac output (measured non-invasively via transthoracic echocardiography) and a number of parameters commonly monitored in the surgical intensive care unit (CVP, SBP/DBP/MBP).
Arterial oximetryDevice
measured by co-oximetry of a blood sample taken via the arterial catheter implemented for critical care
| Study group | Role | What they receive |
|---|---|---|
| 30 cmH20 for 30 seconds | plateau pressure is hold on at 30 cmH20 pour 30 seconds. The cardiac output and the lung aeration is assessed by ultrasound measures at 3 times: before, at the end of the recruitment and 30 minutes later.
echocardiography - arterial oximetry Receives: Device: echocardiography; Device: Arterial oximetry | |
| 10 cmH20 above | plateau pressure is hold on at 10 cmH20 above. The cardiac output and the lung aeration is assessed by ultrasound measures at 3 times: before, at the end of the recruitment and 30 minutes later.
echocardiography - arterial oximetry Receives: Device: echocardiography; Device: Arterial oximetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variations in cardiac output induced by each type of AR manoeuvre
Measured: Day 0
Secondary outcomes (1)
Variations in PaO2 variations induced by each type of AR manoeuvre
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study startNov 2015
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Positive-Pressure RespirationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel LORNE, MD, PhD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02805036
- Sponsor's protocol ID
- PI2015_843_0002
- Acronym
- RHERA1
- Status last verified
- Feb 2017
- First submitted
- 15 Jun 2016
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Hemodynamic Safety of Two Common Alveolar Recruitment Manoeuvres With Regard to Cardiac Output in a Surgical Intensive Care Unit: a Randomized Study
- ClinicalTrials.gov ID
- NCT02805036
- Acronym / sponsor ID
- RHERA1 / PI2015_843_0002
- Conditions
- Positive-Pressure Respiration
- Keywords
- alveolar recruitment, stroke volume/physiology, cardiac output/physiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 17 Jun 2016 (estimated)
- 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.
Protective ventilation - combining a low tidal volume (between 6 and 8 ml/kg) and alveolar recruitment (AR) manoeuvres repeated every 30 minutes - is currently the standard of care for decreasing morbidity associated with mechanical ventilation.
In contrast, there is no consensus on the type of recruitment manoeuvre, which varies from one centre to another and from one study to another.
The investigators intend to compare two currently used AR techniques with regard to their ventilatory efficacy and hemodynamic safety:
- An end-tidal plateau at 30 cmH20 for 30 seconds.
- An end-tidal plateau at 10 cmH20 above the patient's plateau pressure for 30 seconds, without exceeding 30 cmH20.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 30 cmH20 for 30 seconds | – | Device: echocardiography, Device: Arterial oximetryplateau pressure is hold on at 30 cmH20 pour 30 seconds. The cardiac output and the lung aeration is assessed by ultrasound measures at 3 times: before, at the end of the recruitment and 30 minutes later. echocardiography - arterial oximetry |
| 10 cmH20 above | – | Device: echocardiography, Device: Arterial oximetryplateau pressure is hold on at 10 cmH20 above. The cardiac output and the lung aeration is assessed by ultrasound measures at 3 times: before, at the end of the recruitment and 30 minutes later. echocardiography - arterial oximetry |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- sedated, intubated, mechanically ventilated adult patients
Key inclusion criteria (3 listed)
- All sedated, intubated, mechanically ventilated adult patients (over-18) admitted to the surgical intensive care unit and equipped with a central venous catheter and an arterial catheter.
- Good echogenicity
- Social security coverage
Key exclusion criteria (7 listed)
- Pregnancy
- Cardiac arrhythmia
- Poor echogenicity
- Legal guardianship or incarceration
- Systolic blood pressure ≤90 mmHg
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 |
|---|---|---|
| echocardiography• Prospective, simultaneous recording of the cardiac output (measured non-invasively via transthoracic echocardiography) and a number of parameters commonly monitored in the surgical intensive care unit (CVP, SBP/DBP/MBP). | Device | 10 cmH20 above, 30 cmH20 for 30 seconds |
| Arterial oximetrymeasured by co-oximetry of a blood sample taken via the arterial catheter implemented for critical care | Device | 10 cmH20 above, 30 cmH20 for 30 seconds |
Primary outcome
Variations in cardiac output induced by each type of AR manoeuvre
Time frame: Day 0
1 secondary outcome
Variations in PaO2 variations induced by each type of AR manoeuvre
Time frame: Day 0
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 23 Feb 2017.
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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.
Emmanuel LORNE, MD, PhD principal investigator
CHU Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Positive-Pressure Respiration, run by Centre Hospitalier Universitaire, Amiens 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 3 inclusion and 7 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 23 Feb 2017. 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 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?
Variations in cardiac output induced by each type of AR manoeuvre (time frame: Day 0). 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 Feb 2017; AzTrials last refreshed its copy on 8 Nov 2026.