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Functional Residual Capacity (FRC) Guided Alveolar Recruitment Strategy

This study has been completed.
Sponsor:
Information provided by:
University of Luebeck
ClinicalTrials.gov Identifier:
NCT00779090
First received: October 22, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  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

Further study details as provided by University of Luebeck:

Primary Outcome Measures:
  • Arterial oxygenation [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00779090

Sponsors and Collaborators
University of Luebeck
Investigators
Principal Investigator: Hermann Heinze, MD Department of Anaesthesiology, University of Lübeck
  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 November 27, 2014