FRC Guided Therapy in Acute Respiratory Failure

• Sponsor: University of Luebeck (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01280019
• Collaborator: European Society of Intensive Care Medicine (Other)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 19
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

In ventilated patients with acute respiratory failure endotracheal suctioning may lead to alveolar derecruitment, which can be monitored by means of functional residual capacity (FRC) measurements. Regional distribution of ventilation can be followed at bedside using electrical impedance tomography. The investigators hypothesize that a FRC guided recruitment strategy, aimed at restoring a baseline FRC value after open endotracheal suctioning, improves oxygenation and regional distribution of ventilation. In addition the investigators research the impact of such a strategy on the inflammatory response to mechanical ventilation.

Condition or Disease	Intervention/Treatment	Phase
Mechanical Ventilation; Acute Respiratory Failure; Cardiac Surgery	Procedure: alveolar recruitment manoeuvre	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Supportive Care
• Official Title: Functional Residual Capacity Guided Alveolar Recruitment Strategy in Patients With Acute Respiratory Failure After Cardiac Surgery
• Study Start Date: Oct 1, 2010
• Anticipated Primary Completion Date: Dec 1, 2011
• Anticipated Study Completion Date: May 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: FRC guided Patients receive an alveolar recruitment manoeuvre if FRC falls below 94% of baseline FRC	Procedure: alveolar recruitment manoeuvre; Increase of airway pressures in a stepwise manner from set peak inspiratory pressure/ positive end-expiratory pressure up to 40/15 mbar and back over 2 minutes.
Active Comparator: Saturation guided Patients receive an alveolar recruitment manoeuvre if peripheral oxygen saturation falls below 90%	Procedure: alveolar recruitment manoeuvre; Increase of airway pressures in a stepwise manner from set peak inspiratory pressure/ positive end-expiratory pressure up to 40/15 mbar and back over 2 minutes.

Outcome Measures

Primary Outcome Measures

1. Regional ventilation [6 hours]

   Regional distribution of ventilation over 6 hours of treatment

Secondary Outcome Measures

1. arterial oxygenation and inflammation [6 hours]

   Changes of arterial oxygenation and inflammatory parameters in the blood during 6 hours of treatment

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• need for mechanical ventilation due to respiratory failure after cardiac surgery

Exclusion Criteria:

• circulatory failure, eg. need for high doses of inotropes or extracorporal cardiac support

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anaesthesiology, Intensive Care Unit, University of Lübeck	Lübeck		Germany	23538

Sponsors and Collaborators

• University of Luebeck
• European Society of Intensive Care Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01280019
• Other Study ID Numbers: FRC-ARF
• First Posted: Jan 20, 2011
• Last Update Posted: Jan 20, 2011
• Last Verified: Jan 1, 2011

• Keywords provided by , ,: functional residual capacity; electrical impedance tomography; inflammatory parameters
• Additional relevant MeSH terms: Respiratory Insufficiency; Respiratory Distress Syndrome

Study Results

No Results Posted as of Jan 20, 2011