Functional Residual Capacity (FRC) Guided Alveolar Recruitment Strategy

Ventilation Clinical Trial

Official title:

The Influence of a Functional Residual Capacity Guided Alveolar Recruitment Strategy After Open Endotracheal Suctioning on Oxygenation and Regional Ventilation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00779090
• Other study ID #: FRCGARS-1
• Status: Completed
• Phase: Phase 4
• First received: October 22, 2008
• Last updated: October 22, 2008
• Start date: October 2007
• Est. completion date: October 2008

Study information

• Verified date: October 2008
• Source: University of Luebeck
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: October 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Functional Residual Capacity
• Ventilation

Intervention

Procedure:
• Alveolar recruitment manoeuvre
Increase airway pressure during pressure controlled ventilation up to peak-airway pressure of 40 cmH20 and PEEP of 15 cmH20.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Luebeck

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arterial oxygenation		60 minutes	No
Secondary	Regional ventilation		60 minutes	No