Mechanical VentilationPhase 4NCT01280019
FRC Guided Therapy in Acute Respiratory Failure
A Phase 4 study testing alveolar recruitment manoeuvre in people with Mechanical Ventilation and Acute Respiratory Failure, run by University of Luebeck at 1 site in Germany.
Trial summary
In ventilated patients with acute respiratory failure endotracheal suctioning may lead to alveolar derecruitment, which can be monitored by means of functional residual capacity (FRC) measurements. Regional distribution of ventilation can be followed at bedside using electrical impedance tomography. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation, Acute Respiratory Failure, Cardiac Surgery
- What is being tested?
- alveolar recruitment manoeuvre
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2010to May 2012
- Phase
- Phase 4
- 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
- need for mechanical ventilation due to respiratory failure after cardiac surgery
Who cannot join
- circulatory failure, eg. need for high doses of inotropes or extracorporal cardiac support
Trial locations and contacts
1 site in 1 country.
Hermann Heinze, MD contact
Germany1 site, 1 recruiting
- Recruiting
Department of Anaesthesiology, Intensive Care Unit, University of Lübeck
Lübeck, 23538
Hermann Heinze, MD, +49 451 500 ext. 4057, Hermann.heinze@uk-sh.de
Hermann Heinze, MD
About this study
Official title: Functional Residual Capacity Guided Alveolar Recruitment Strategy in Patients With Acute Respiratory Failure After Cardiac Surgery
In ventilated patients with acute respiratory failure endotracheal suctioning may lead to alveolar derecruitment, which can be monitored by means of functional residual capacity (FRC) measurements. Regional distribution of ventilation can be followed at bedside using electrical impedance tomography. The investigators hypothesize that a FRC guided recruitment strategy, aimed at restoring a baseline FRC value after open endotracheal suctioning, improves oxygenation and regional distribution of ventilation. In addition the investigators research the impact of such a strategy on the inflammatory response to mechanical ventilation.
- Being tested
- alveolar recruitment manoeuvre
- Keywords
- functional residual capacity, electrical impedance tomography, inflammatory parameters
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alveolar recruitment manoeuvreProcedure or surgery
Increase of airway pressures in a stepwise manner from set peak inspiratory pressure/ positive end-expiratory pressure up to 40/15 mbar and back over 2 minutes.
| Study group | Role | What they receive |
|---|---|---|
| FRC guided | Experimental | Patients receive an alveolar recruitment manoeuvre if FRC falls below 94% of baseline FRC Receives: Procedure: alveolar recruitment manoeuvre |
| Saturation guided | Active comparator | Patients receive an alveolar recruitment manoeuvre if peripheral oxygen saturation falls below 90% Receives: Procedure: alveolar recruitment manoeuvre |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional ventilation
Regional distribution of ventilation over 6 hours of treatment
Measured: 6 hours
Secondary outcomes (1)
arterial oxygenation and inflammation
Changes of arterial oxygenation and inflammatory parameters in the blood during 6 hours of treatment
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2011 (estimated)
- Study startOct 2010
- Primary completionDec 2011 (estimated)
- Study completionMay 2012 (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.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Luebeck
- Sponsor type
- University, hospital or other
- Collaborators
- European Society of Intensive Care Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01280019
- Sponsor's protocol ID
- FRC-ARF
- Status last verified
- Jan 2011
- First submitted
- 19 Jan 2011
- Last updated
- 20 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Residual Capacity Guided Alveolar Recruitment Strategy in Patients With Acute Respiratory Failure After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT01280019
- Acronym / sponsor ID
- FRC-ARF
- Keywords
- functional residual capacity, electrical impedance tomography, inflammatory parameters
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of LuebeckUniversity, hospital or other
- Collaborators
- European Society of Intensive Care Medicine
- Study start
- Oct 2010
- Primary completion
- Dec 2011 (estimated)
- Study completion
- May 2012 (estimated)
- First posted
- 20 Jan 2011 (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.
In ventilated patients with acute respiratory failure endotracheal suctioning may lead to alveolar derecruitment, which can be monitored by means of functional residual capacity (FRC) measurements. Regional distribution of ventilation can be followed at bedside using electrical impedance tomography. The investigators hypothesize that a FRC guided recruitment strategy, aimed at restoring a baseline FRC value after open endotracheal suctioning, improves oxygenation and regional distribution of ventilation. In addition the investigators research the impact of such a strategy on the inflammatory response to mechanical ventilation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FRC guided | Experimental | Procedure: alveolar recruitment manoeuvrePatients receive an alveolar recruitment manoeuvre if FRC falls below 94% of baseline FRC |
| Saturation guided | Active comparator | Procedure: alveolar recruitment manoeuvrePatients receive an alveolar recruitment manoeuvre if peripheral oxygen saturation falls below 90% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- need for mechanical ventilation due to respiratory failure after cardiac surgery
Key exclusion criteria (1 listed)
- circulatory failure, eg. need for high doses of inotropes or extracorporal cardiac support
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 manoeuvreIncrease of airway pressures in a stepwise manner from set peak inspiratory pressure/ positive end-expiratory pressure up to 40/15 mbar and back over 2 minutes. | Procedure or surgery | FRC guided, Saturation guided |
Primary outcome
Regional ventilation
Time frame: 6 hours
Regional distribution of ventilation over 6 hours of treatment
1 secondary outcome
arterial oxygenation and inflammation
Time frame: 6 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2011.
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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.
Hermann Heinze, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing alveolar recruitment manoeuvre in people with Mechanical Ventilation and Acute Respiratory Failure, run by University of Luebeck 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 1 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 20 Jan 2011. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Hermann Heinze, MD (Hermann.heinze@uk-sh.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regional ventilation (time frame: 6 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 20 Jan 2011.