Functional Residual Capacity (FRC) Guided Alveolar Recruitment Strategy

Phase 4

Completed

• Conditions: Ventilation; Functional Residual Capacity
• Interventions: Procedure: Alveolar recruitment manoeuvre

• Registration Number: NCT00779090
• Lead Sponsor: University of Luebeck

Brief Summary

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

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.

Study Timeline

• Study Start: 2007-10
• Primary Completion: 2008-04
• Status Verified: 2008-10
• Study Completion: 2008-10
• Study First Submitted: 2008-10-22
• Study First Submitted QC: 2008-10-22
• Last Update Submitted: 2008-10-22
• Study First Posted: 2008-10-24
• Last Update Posted: 2008-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A_RM	Alveolar recruitment manoeuvre	Patients with FRC after open endotracheal suctioning of more than 94% of baseline randomized to receive an alveolar recruitment manoeuvre.
Group B_RM	Alveolar recruitment manoeuvre	Patients with FRC after open endotracheal suctioning of less than 94% of baseline randomized to receive an alveolar recruitment manoeuvre.

Primary Outcome Measures

Name	Time	Method
Arterial oxygenation	60 minutes

Secondary Outcome Measures

Name	Time	Method
Regional ventilation	60 minutes