- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02670733
Effect of Increased Positive End-expiratory Pressure on Intracranial Pressure in Different Respiratory Mechanic in Acute Respiratory Distress Syndrome
There are concerns that the use of positive end-expiratory pressure (PEEP) for the treatment of pulmonary complications in patients with brain injury may potentially elevate intracranial pressure (ICP), and deteriorate neurological status. It is suggested that both respiratory system compliance and ventricular compliance would contribute to the elevation of ICP when PEEP increases. In theory, PEEP may cause elevation of ICP by increasing intrathoracic pressure and diminish venous return. However, the transmission of PEEP into thoracic cavity depends on the properties of the lung and chest wall. Experimental study showed that when chest wall compliance is low, PEEP can significantly increases intrathoracic pressure; whereas low lung compliance can minimize airway pressure transmission. It is generally recognized that the lung compliance decreases in acute respiratory distress syndrome (ARDS) patients due to extensive alveolar collapse. However, it has been report that the elastance ratio (the ratio between elastance of the chest wall and the respiratory system, where elastance is the reciprocal of compliance) may vary from 0.2 to 0.8. Therefore, it is important to distinguish the compliance of the chest wall and the lung when investigating the effect of PEEP on ICP.
Because intrathoracic pressure (pleural pressure) is difficult to measure in clinical situations, esophageal pressure (Pes) is considered as a surrogate of intrathoracic pressure. In the present study, the investigators determine the effect of PEEP on intrathoracic pressure and ICP by Pes measurement.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 18 years and above;
- Glasgow Coma Score ≤ 8;
- Ventricular ICP monitor was placed for ICP monitoring and cerebrospinal fluid (CSF) drainage;
- Need for mechanical ventilation with PEEP;
- ARDS was diagnosed according to Berlin Definition.
Exclusion Criteria:
- Hemodynamic instability requiring more than 10 μg/kg/min dopamine or more than 0.5 μg/kg/min norepinephrine;
- ICP > 25 mmHg;
- Esophageal varices;
- History of esophageal or gastric surgery;
- Evidence of active air leak from the lung, including bronchopleural fistula, pneumothorax, pneumomediastinum, or existing chest tube;
- History of chronic obstructive pulmonary disease.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
high responsiveness of ICP to PEEP
After increasing positive end-expiratory pressure (PEEP) from 5 cmH2O to 15 cmH2O, intracranial pressure (ICP) increases above the median for the study population.
|
Positive end-expiratory pressure will be applied at 5 cmH2O and 15 cmH2O
Other Names:
|
low responsiveness of ICP to PEEP
After increasing positive end-expiratory pressure (PEEP) from 5 cmH2O to 15 cmH2O, the level of intracranial pressure (ICP) increases below the median for the study population.
|
Positive end-expiratory pressure will be applied at 5 cmH2O and 15 cmH2O
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in ICP level in different PEEP levels
Time Frame: Baseline ICP at PEEP of 5 cmH2O, and 15 minutes after increasing the PEEP level to 15 cmH2O
|
Baseline ICP at PEEP of 5 cmH2O, and 15 minutes after increasing the PEEP level to 15 cmH2O
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- K2015-023-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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