FRC Guided Therapy in Acute Respiratory Failure

NCT ID: NCT01280019

Last Updated: 2011-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2012-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Mechanical Ventilation Acute Respiratory Failure Cardiac Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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FRC guided

Patients receive an alveolar recruitment manoeuvre if FRC falls below 94% of baseline FRC

Group Type EXPERIMENTAL

alveolar recruitment manoeuvre

Intervention Type PROCEDURE

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.

Saturation guided

Patients receive an alveolar recruitment manoeuvre if peripheral oxygen saturation falls below 90%

Group Type ACTIVE_COMPARATOR

alveolar recruitment manoeuvre

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Society of Intensive Care Medicine

OTHER

Sponsor Role collaborator

University of Luebeck

OTHER

Sponsor Role lead

Responsible Party

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Department of Anaesthesiology, University of Lübeck

Locations

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Department of Anaesthesiology, Intensive Care Unit, University of Lübeck

Lübeck, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Hermann Heinze, MD

Role: CONTACT

Facility Contacts

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Hermann Heinze, MD

Role: primary

+49 451 500 ext. 4057

Other Identifiers

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FRC-ARF

Identifier Type: -

Identifier Source: org_study_id

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