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Functional Residual Capacity (FRC) Guided Alveolar Recruitment Strategy

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ClinicalTrials.gov Identifier: NCT00779090
Recruitment Status : Completed
First Posted : October 24, 2008
Last Update Posted : October 24, 2008
Sponsor:
Information provided by:
University of Luebeck

Brief 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 open endotracheal suctioning manoeuvre.

Condition or disease Intervention/treatment Phase
Ventilation Functional Residual Capacity Procedure: Alveolar recruitment manoeuvre Phase 4

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
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
Study Start Date : October 2007
Actual Primary Completion Date : April 2008
Actual Study Completion Date : October 2008

Arm Intervention/treatment
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.



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

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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

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 Posted: October 24, 2008    Key Record Dates
Last Update Posted: October 24, 2008
Last Verified: October 2008