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

NCT02670733 | Completed

• 1 other identifier: K2015-023-01
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Keywords

mechanical ventilation; positive end-expiratory pressure

Outcome Measures

Primary Outcomes (1)

• Change in ICP level in different PEEP levels

  Baseline ICP at PEEP of 5 cmH2O, and 15 minutes after increasing the PEEP level to 15 cmH2O

Study Arms (2)

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

Positive end-expiratory pressure PROCEDURE

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

Also known as: PEEP

high responsiveness of ICP to PEEP; low responsiveness of ICP to PEEP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Severe brain injured patients with ARDS

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Capital Medical University: lead

Related Publications (1)

• 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.

  PMID: 27852713 DERIVED

MeSH Terms

Conditions

Brain Injuries

Interventions

Positive-Pressure Respiration

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 26, 2016
• First Posted: February 2, 2016
• Study Start: January 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 28, 2017

Record last verified: 2017-01