Effect of Increased Positive End-expiratory Pressure on Intracranial Pressure in Different Respiratory Mechanic in Acute Respiratory Distress Syndrome

March 24, 2017 updated by: Jian-Xin Zhou, Capital Medical University

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

Completed

Study Type

Observational

Enrollment (Actual)

30

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Severe brain injured patients with ARDS

Description

Inclusion Criteria:

  1. Age 18 years and above;
  2. Glasgow Coma Score ≤ 8;
  3. Ventricular ICP monitor was placed for ICP monitoring and cerebrospinal fluid (CSF) drainage;
  4. Need for mechanical ventilation with PEEP;
  5. ARDS was diagnosed according to Berlin Definition.

Exclusion Criteria:

  1. Hemodynamic instability requiring more than 10 μg/kg/min dopamine or more than 0.5 μg/kg/min norepinephrine;
  2. ICP > 25 mmHg;
  3. Esophageal varices;
  4. History of esophageal or gastric surgery;
  5. Evidence of active air leak from the lung, including bronchopleural fistula, pneumothorax, pneumomediastinum, or existing chest tube;
  6. History of chronic obstructive pulmonary disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • PEEP
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:
  • PEEP

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

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (ACTUAL)

December 1, 2016

Study Completion (ACTUAL)

December 1, 2016

Study Registration Dates

First Submitted

January 26, 2016

First Submitted That Met QC Criteria

January 28, 2016

First Posted (ESTIMATE)

February 2, 2016

Study Record Updates

Last Update Posted (ACTUAL)

March 28, 2017

Last Update Submitted That Met QC Criteria

March 24, 2017

Last Verified

January 1, 2017

More Information

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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