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

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ClinicalTrials.gov Identifier: NCT02670733
Recruitment Status : Completed
First Posted : February 2, 2016
Last Update Posted : March 28, 2017
Sponsor:
Information provided by (Responsible Party):
Jian-Xin Zhou, Capital Medical University

Brief Summary:

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.


Condition or disease Intervention/treatment
Acute Brain Injuries Procedure: Positive end-expiratory pressure

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : January 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016


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.
Procedure: Positive end-expiratory pressure
Positive end-expiratory pressure will be applied at 5 cmH2O and 15 cmH2O
Other Name: 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.
Procedure: Positive end-expiratory pressure
Positive end-expiratory pressure will be applied at 5 cmH2O and 15 cmH2O
Other Name: PEEP




Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Severe brain injured patients with ARDS
Criteria

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.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jian-Xin Zhou, Clinical Professor, Capital Medical University
ClinicalTrials.gov Identifier: NCT02670733    
Other Study ID Numbers: K2015-023-01
First Posted: February 2, 2016    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: January 2017
Keywords provided by Jian-Xin Zhou, Capital Medical University:
mechanical ventilation
positive end-expiratory pressure
Additional relevant MeSH terms:
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Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries