EIT-PEEP: Strategies to Optimize Positive End-expiratory Pressure (PEEP) in Patients With Acute Lung Injury

• Sponsor: University Hospital, Bonn (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01326208
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arm: 1
• Duration (Months): 27
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

The purpose of this study in patients suffering from acute lung injury is to determine whether positive end-expiratory pressure (PEEP) setting guided by electrical impedance tomography (EIT) influences pulmonary gas exchange, lung mechanics, ventilation/perfusion matching and homogeneity of regional ventilation when compared to other PEEP setting strategies such as the open lung concept or the ARDSnet protocol.

Condition or Disease	Intervention/Treatment	Phase
Acute Lung Injury; Acute Respiratory Distress Syndrome; Respiratory Failure	Procedure: PEEP titration	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Influence of Different Strategies to Optimize Positive End-expiratory Pressure on Pulmonary Gas Exchange, Perfusion/Ventilation Matching and Homogeneity of Ventilation in Patients With Acute Lung Injury
• Study Start Date: Mar 1, 2011
• Anticipated Primary Completion Date: Dec 1, 2012
• Anticipated Study Completion Date: Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Acute Lung Injury / ARDS Patient under mechanical suffering from ALI or ARDS	Procedure: PEEP titration; PEEP is set according to the following protocols, respectively, in a randomized order: ARDSnet table, Open Lung strategy, guided by EIT; Other Names: electrical impedance tomography guided setting of PEEP

Outcome Measures

Primary Outcome Measures

1. homogeneity of regional ventilation delay [up to eight hours]

   influence of different PEEP titration strategies on homogeneity of regional ventilation delay measured by electrical impedance tomography

Secondary Outcome Measures

1. pulmonary gas exchange, lung mechanics and ventilation/perfusion matching [up to eight hours]

   influence of different PEEP titration strategies on pulmonary gas exchange, lung mechanics and ventilation/perfusion matching

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• acute lung injury, need for optimization of ventilatory settings

Exclusion Criteria:

• preexisting chronical lung disease, pneumothorax, pace maker, hemodynamical instability, increased intracranial pressure

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital	Bonn		Germany	53105

Sponsors and Collaborators

• University Hospital, Bonn

Investigators

• Study Chair: Christian Putensen, MD, Prof, University of Bonn
• Principal Investigator: Thomas Muders, MD, University of Bonn

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01326208
• Other Study ID Numbers: EIT-PEEP-2010
• First Posted: Mar 30, 2011
• Last Update Posted: Mar 30, 2011
• Last Verified: Mar 1, 2011

• Keywords provided by , ,: electrical impedance tomography; positive end-expiratory pressure; regional ventilation delay index
• Additional relevant MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Respiratory Insufficiency; Acute Lung Injury; Lung Injury; Wounds and Injuries

Study Results

No Results Posted as of Mar 30, 2011