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

Acute Brain Injuries Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02670733
• Other study ID #: K2015-023-01
• Status: Completed
• Phase: N/A
• First received: January 26, 2016
• Last updated: March 24, 2017
• Start date: January 2016
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Capital Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Brain Injuries
• Acute Lung Injury
• Brain Injuries
• Respiratory Distress Syndrome, Adult

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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