VentilationPhase 4NCT00779090
Functional Residual Capacity (FRC) Guided Alveolar Recruitment Strategy
A Phase 4 study testing Alveolar recruitment manoeuvre in people with Ventilation and Functional Residual Capacity, run by University of Luebeck.
Trial summary
In ventilated patients open endotracheal suctioning may lead to alveolar derecruitment, which can be monitored by means of functional residual capacity (FRC) measurements. The investigators hypothesized that a recruitment strategy based on FRC measurements would improve oxygenation and regional ventilation after an… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilation, Functional Residual Capacity
- 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
- 59 participants
- Where
- No sites listed yet
- Study dates
- Oct 2007to Oct 2008
- 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
- ventilated after elective cardiac surgery
Who cannot join
- hemodynamic instability (eg. intraaortic balloon pump)
- acute lung injury, i.e. PEEP > 10cmH20 or FiO2 > 0.4
About this study
Official title: The Influence of a Functional Residual Capacity Guided Alveolar Recruitment Strategy After Open Endotracheal Suctioning on Oxygenation and Regional Ventilation
In ventilated patients open endotracheal suctioning may lead to alveolar derecruitment, which can be monitored by means of functional residual capacity (FRC) measurements. The investigators hypothesized that a recruitment strategy based on FRC measurements would improve oxygenation and regional ventilation after an open endotracheal suctioning manoeuvre.
Read the detailed description
In mechanically ventilated patients the functional residual capacity will be measured before (baseline) and after an open endotracheal suctioning manoeuvre. Based on these changes patients will be divided into two groups: Group A with more than 94% of baseline FRC, and Group B with less than 94% of baseline FRC. Both groups will be randomized to receive an alveolar recruitment manoeuvre or no alveolar recruitment manoeuvre, leading to four groups. Oxygenation and regional ventilation with electrical impedance tomography will be studied.
- Conditions
- Ventilation, Functional Residual Capacity
- Being tested
- Alveolar recruitment manoeuvre
- Medical subject headings
- Respiratory Aspiration
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 airway pressure during pressure controlled ventilation up to peak-airway pressure of 40 cmH20 and PEEP of 15 cmH20.
| Study group | Role | What they receive |
|---|---|---|
| Group A_RM | Experimental | Patients with FRC after open endotracheal suctioning of more than 94% of baseline randomized to receive an alveolar recruitment manoeuvre. Receives: Procedure: Alveolar recruitment manoeuvre |
| Group A_NRM | No intervention | Patients with FRC after open endotracheal suctioning of more than 94% of baseline randomized to receive no alveolar recruitment manoeuvre. |
| Group B_RM | Experimental | Patients with FRC after open endotracheal suctioning of less than 94% of baseline randomized to receive an alveolar recruitment manoeuvre. Receives: Procedure: Alveolar recruitment manoeuvre |
| Group B_NRM | No intervention | Patients with FRC after open endotracheal suctioning of less than 94% of baseline randomized to receive no alveolar recruitment manoeuvre. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial oxygenation
Measured: 60 minutes
Secondary outcomes (1)
Regional ventilation
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2008 (estimated)
- Study startOct 2007
- Primary completionApr 2008
- Study completionOct 2008
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 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
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Luebeck
- Sponsor type
- University, hospital or other
- Investigators
- Hermann Heinze, MD, Principal investigator, Department of Anaesthesiology, University of Lübeck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00779090
- Sponsor's protocol ID
- FRCGARS-1
- Status last verified
- Oct 2008
- First submitted
- 22 Oct 2008
- Last updated
- 24 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Heinze H, Eichler W, Karsten J, Sedemund-Adib B, Heringlake M, Meier T. Functional residual capacity-guided alveolar recruitment strategy after endotracheal suctioning in cardiac surgery patients. Crit Care Med. 2011 May;39(5):1042-9. doi: 10.1097/CCM.0b013e31820eb736.
PubMed 21336125
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of a Functional Residual Capacity Guided Alveolar Recruitment Strategy After Open Endotracheal Suctioning on Oxygenation and Regional Ventilation
- ClinicalTrials.gov ID
- NCT00779090
- Acronym / sponsor ID
- FRCGARS-1
- Conditions
- Ventilation, Functional Residual Capacity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of LuebeckUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 24 Oct 2008 (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 open endotracheal suctioning may lead to alveolar derecruitment, which can be monitored by means of functional residual capacity (FRC) measurements. The investigators hypothesized that a recruitment strategy based on FRC measurements would improve oxygenation and regional ventilation after an open endotracheal suctioning manoeuvre.
Detailed description
In mechanically ventilated patients the functional residual capacity will be measured before (baseline) and after an open endotracheal suctioning manoeuvre. Based on these changes patients will be divided into two groups: Group A with more than 94% of baseline FRC, and Group B with less than 94% of baseline FRC. Both groups will be randomized to receive an alveolar recruitment manoeuvre or no alveolar recruitment manoeuvre, leading to four groups. Oxygenation and regional ventilation with electrical impedance tomography will be studied.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A_RM | Experimental | Procedure: Alveolar recruitment manoeuvrePatients with FRC after open endotracheal suctioning of more than 94% of baseline randomized to receive an alveolar recruitment manoeuvre. |
| Group A_NRM | No intervention | –Patients with FRC after open endotracheal suctioning of more than 94% of baseline randomized to receive no alveolar recruitment manoeuvre. |
| Group B_RM | Experimental | Procedure: Alveolar recruitment manoeuvrePatients with FRC after open endotracheal suctioning of less than 94% of baseline randomized to receive an alveolar recruitment manoeuvre. |
| Group B_NRM | No intervention | –Patients with FRC after open endotracheal suctioning of less than 94% of baseline randomized to receive no alveolar recruitment manoeuvre. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ventilated after elective cardiac surgery
Key exclusion criteria (2 listed)
- hemodynamic instability (eg. intraaortic balloon pump)
- acute lung injury, i.e. PEEP > 10cmH20 or FiO2 > 0.4
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 airway pressure during pressure controlled ventilation up to peak-airway pressure of 40 cmH20 and PEEP of 15 cmH20. | Procedure or surgery | Group A_RM, Group B_RM |
Primary outcome
Arterial oxygenation
Time frame: 60 minutes
1 secondary outcome
Regional ventilation
Time frame: 60 minutes
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 24 Oct 2008.
- Derived from this study: PubMed 21336125Heinze H, Eichler W, Karsten J, Sedemund-Adib B, Heringlake M, Meier T. Functional residual capacity-guided alveolar recruitment strategy after endotracheal suctioning in cardiac surgery patients. Crit Care Med. 2011 May;39(5):1042-9. doi: 10.1097/CCM.0b013e31820eb736.
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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 principal investigator
Department of Anaesthesiology, University of Lübeck
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Alveolar recruitment manoeuvre in people with Ventilation and Functional Residual Capacity, run by University of Luebeck.
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 2 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 24 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Arterial oxygenation (time frame: 60 minutes). 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 NCT00779090, 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 24 Oct 2008.