NCT00779090

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2007

Shorter than P25 for phase_4

Status
completed

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, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 24, 2008

Completed
Last Updated

October 24, 2008

Status Verified

October 1, 2008

Enrollment Period

6 months

First QC Date

October 22, 2008

Last Update Submit

October 22, 2008

Conditions

Outcome Measures

Primary Outcomes (1)

  • Arterial oxygenation

    60 minutes

Secondary Outcomes (1)

  • Regional ventilation

    60 minutes

Study Arms (4)

Group A_RM

EXPERIMENTAL

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

Procedure: Alveolar recruitment manoeuvre

Group A_NRM

NO INTERVENTION

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

Group B_RM

EXPERIMENTAL

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

Procedure: Alveolar recruitment manoeuvre

Group B_NRM

NO INTERVENTION

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

Interventions

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

Group A_RMGroup B_RM

Eligibility Criteria

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

You may qualify if:

  • ventilated after elective cardiac surgery

You may not qualify if:

  • hemodynamic instability (eg. intraaortic balloon pump)
  • acute lung injury, i.e. PEEP \> 10cmH20 or FiO2 \> 0.4

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Hermann Heinze, MD

    Department of Anaesthesiology, University of Lübeck

    PRINCIPAL INVESTIGATOR

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

October 22, 2008

First Posted

October 24, 2008

Study Start

October 1, 2007

Primary Completion

April 1, 2008

Study Completion

October 1, 2008

Last Updated

October 24, 2008

Record last verified: 2008-10