Functional Residual Capacity (FRC) Guided Alveolar Recruitment Strategy
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Ventilation Functional Residual Capacity |
Procedure: Alveolar recruitment manoeuvre |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Supportive Care |
| Official Title: | The Influence of a Functional Residual Capacity Guided Alveolar Recruitment Strategy After Open Endotracheal Suctioning on Oxygenation and Regional Ventilation |
- Arterial oxygenation [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
- Regional ventilation [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
| Enrollment: | 59 |
| Study Start Date: | October 2007 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group A_RM
Patients with FRC after open endotracheal suctioning of more than 94% of baseline randomized to receive an alveolar recruitment manoeuvre.
|
Procedure: Alveolar recruitment manoeuvre
Increase airway pressure during pressure controlled ventilation up to peak-airway pressure of 40 cmH20 and PEEP of 15 cmH20.
|
|
No Intervention: Group A_NRM
Patients with FRC after open endotracheal suctioning of more than 94% of baseline randomized to receive no alveolar recruitment manoeuvre.
|
|
|
Experimental: Group B_RM
Patients with FRC after open endotracheal suctioning of less than 94% of baseline randomized to receive an alveolar recruitment manoeuvre.
|
Procedure: Alveolar recruitment manoeuvre
Increase airway pressure during pressure controlled ventilation up to peak-airway pressure of 40 cmH20 and PEEP of 15 cmH20.
|
|
No Intervention: Group B_NRM
Patients with FRC after open endotracheal suctioning of less than 94% of baseline randomized to receive no alveolar recruitment 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- ventilated after elective cardiac surgery
Exclusion Criteria:
- hemodynamic instability (eg. intraaortic balloon pump)
- acute lung injury, i.e. PEEP > 10cmH20 or FiO2 > 0.4
Contacts and Locations More Information
No publications provided by University of Luebeck
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Hermann Heinze, Department of Anaesthesiology, University of Lübeck, Germany |
| ClinicalTrials.gov Identifier: | NCT00779090 History of Changes |
| Other Study ID Numbers: | FRCGARS-1 |
| Study First Received: | October 22, 2008 |
| Last Updated: | October 22, 2008 |
| Health Authority: | Germany: Ethics Commission |
ClinicalTrials.gov processed this record on May 19, 2013