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CompletedNCT02670733Updated Mar 28, 2017

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

An observational study in Acute Brain Injuries, sponsored by Capital Medical University. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-28.

Sponsored by Capital Medical University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Acute Brain Injuries

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Keywords

  • mechanical ventilation
  • positive end-expiratory pressure
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In context

Brain Injuries

2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.

This study's enrollment of 30 is below the median of 100 across 690 observational studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

Capital Medical University is the lead sponsor of 283 studies on the registry; 92 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Severe brain injured patients with ARDS

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • 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

Interventions

  • ProcedurePositive end-expiratory pressure

    Positive end-expiratory pressure will be applied at 5 cmH2O and 15 cmH2O

    Also known as: PEEP

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What researchers measure

Primary outcomes

  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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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Chen H, Xu M, Yang YL, Chen K, Xu JQ, Zhang YR, Yu RG, Zhou JX. Effects of increased positive end-expiratory pressure on intracranial pressure in acute respiratory distress syndrome: a protocol of a prospective physiological study. BMJ Open. 2016 Nov 15;6(11):e012477. doi: 10.1136/bmjopen-2016-012477. PubMed 27852713 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02670733
Lead sponsor
Capital Medical University
Responsible party
Jian-Xin Zhou (Clinical Professor, Capital Medical University) — Principal investigator
First posted
Feb 2, 2016
Start date
Jan 2016
Primary completion
Dec 2016
Completion
Dec 2016
Last update
Mar 28, 2017
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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