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Functional Residual Capacity (FRC) Guided Alveolar Recruitment Strategy

NCT ID: NCT00779090

Last Updated: 2008-10-24

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Ventilation Functional Residual Capacity

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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Group A_RM

Patients with FRC after open endotracheal suctioning of more than 94% of baseline randomized to receive an alveolar recruitment manoeuvre.

Group Type EXPERIMENTAL

Alveolar recruitment manoeuvre

Intervention Type PROCEDURE

Increase airway pressure during pressure controlled ventilation up to peak-airway pressure of 40 cmH20 and PEEP of 15 cmH20.

Group A_NRM

Patients with FRC after open endotracheal suctioning of more than 94% of baseline randomized to receive no alveolar recruitment manoeuvre.

Group Type NO_INTERVENTION

No interventions assigned to this group

Group B_RM

Patients with FRC after open endotracheal suctioning of less than 94% of baseline randomized to receive an alveolar recruitment manoeuvre.

Group Type EXPERIMENTAL

Alveolar recruitment manoeuvre

Intervention Type PROCEDURE

Increase airway pressure during pressure controlled ventilation up to peak-airway pressure of 40 cmH20 and PEEP of 15 cmH20.

Group B_NRM

Patients with FRC after open endotracheal suctioning of less than 94% of baseline randomized to receive no alveolar recruitment manoeuvre.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Alveolar recruitment manoeuvre

Increase airway pressure during pressure controlled ventilation up to peak-airway pressure of 40 cmH20 and PEEP of 15 cmH20.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Luebeck

OTHER

Sponsor Role lead

Responsible Party

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Department of Anaesthesiology, University of Lübeck, Germany

Principal Investigators

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Hermann Heinze, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anaesthesiology, University of Lübeck

References

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Heinze H, Eichler W, Karsten J, Sedemund-Adib B, Heringlake M, Meier T. Functional residual capacity-guided alveolar recruitment strategy after endotracheal suctioning in cardiac surgery patients. Crit Care Med. 2011 May;39(5):1042-9. doi: 10.1097/CCM.0b013e31820eb736.

Reference Type DERIVED
PMID: 21336125 (View on PubMed)

Other Identifiers

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FRCGARS-1

Identifier Type: -

Identifier Source: org_study_id