NCT01280019

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 20, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

January 20, 2011

Status Verified

January 1, 2011

Enrollment Period

1.2 years

First QC Date

January 19, 2011

Last Update Submit

January 19, 2011

Conditions

Mechanical VentilationAcute Respiratory FailureCardiac Surgery

Keywords

functional residual capacityelectrical impedance tomographyinflammatory parameters

Outcome Measures

Primary Outcomes (1)

  • Regional ventilation

    Regional distribution of ventilation over 6 hours of treatment

    6 hours

Secondary Outcomes (1)

  • arterial oxygenation and inflammation

    6 hours

Study Arms (2)

FRC guided

EXPERIMENTAL

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

Procedure: alveolar recruitment manoeuvre

Saturation guided

ACTIVE COMPARATOR

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

Procedure: alveolar recruitment manoeuvre

Interventions

alveolar recruitment manoeuvrePROCEDURE

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.

FRC guidedSaturation guided

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anaesthesiology, Intensive Care Unit, University of Lübeck

Lübeck, 23538, Germany

RECRUITING

Central Study Contacts

Hermann Heinze, MD

CONTACT

Hermann.heinze@uk-sh.de

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 19, 2011

First Posted

January 20, 2011

Study Start

October 1, 2010

Primary Completion

December 1, 2011

Study Completion

May 1, 2012

Last Updated

January 20, 2011

Record last verified: 2011-01

Locations

DE(1)