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

NCT ID: NCT02670733

Last Updated: 2017-03-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2016-12-31

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.

Conditions

Acute Brain Injuries

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Intervention Type: PROCEDURE

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

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

Intervention Type: PROCEDURE

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

Interventions

Positive end-expiratory pressure

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

Intervention Type: PROCEDURE

Other Intervention Names

PEEP

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Capital Medical University

OTHER

Sponsor Role: lead

Responsible Party

Jian-Xin Zhou

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 27852713 (View on PubMed)

Other Identifiers

K2015-023-01

Identifier Type: -

Identifier Source: org_study_id