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Functional Residual Capacity (FRC) Guided Alveolar Recruitment Strategy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00779090
First Posted: October 24, 2008
Last Update Posted: October 24, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Luebeck
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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

Further study details as provided by University of Luebeck:

Primary Outcome Measures:
  • Arterial oxygenation [ Time Frame: 60 minutes ]

Secondary Outcome Measures:
  • Regional ventilation [ Time Frame: 60 minutes ]

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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00779090


Sponsors and Collaborators
University of Luebeck
Investigators
Principal Investigator: Hermann Heinze, MD Department of Anaesthesiology, University of Lübeck
  More Information

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
First Submitted: October 22, 2008
First Posted: October 24, 2008
Last Update Posted: October 24, 2008
Last Verified: October 2008