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Clinical Trials/NCT04935008
NCT04935008CompletedNot Applicable

Evaluation of Intracranial Pressure Change by Measuring Optic Nerve Sheath Diameter During Lung Recruitment Maneuver in Patients With Acute Respiratory Distress Syndrome: A Prospective Experimental Study

Ondokuz Mayıs University1 site in 1 country81 target enrollmentStarted: July 1, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
81
Locations
1
Primary Endpoint
Effect of recruitment maneuver on optic nerve sheath diameter (ONSD)

Study Overview

Brief Summary

Recruitment maneuver is used to reopen atelectasis alveoli. Positive airway pressure applied during the recruitment maneuver may increase intrathoracic pressure, resulting in hemodynamic instability, venous return disorders, and increased intracranial pressure. Our study will examine the effect of recruitment maneuver on intracranial pressure by evaluating Optic Nerve Sheath Diameter change.

Detailed Description

The therapeutic goal of mechanical ventilation shifts from maintaining regular gas exchange to preventing ventilator-induced lung injury. Atelectasis aggravates lung injury by reducing the lung size available for tidal ventilation. By preventing atelectasis with Positive End Expiratory Pressure (PEEP) and recruitment maneuvers, the end-expiratory lung volume can be increased, and lung damage can be reduced.

Although the recruitment maneuver improves oxygenation and reduces mortality, especially in patients with Acute Respiratory Distress Syndrome (ARDS), adverse side effects are sometimes observed. Most important of these are the risk of barotrauma after positive airway pressure applications, increased intrathoracic pressure and hemodynamic instability, and increased intracranial pressure risk after venous return disorder.

Our study aimed to evaluate the effect of recruitment maneuver on intracranial pressure by measuring optic nerve diameter with ultrasound before and after its application in patients with ARDS with impaired oxygenation and followed up with mechanical ventilator support.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients older than 18 years
  • •Patients followed in the Intensive Care Unit (ICU)
  • •Patients on mechanical ventilation support
  • •Patients diagnosed with ARDS according to the Berlin criteria
  • •Patients with oxygen saturation (SpO2) ≤ 92%

Exclusion Criteria

  • •Younger than 18
  • •Patients with increased inotropic drug requirement or mean arterial pressure <65 mmHg in the last 2 hours
  • •Patients with intracranial hypertension
  • •Patients with acute coronary syndrome
  • •Patients with hypercapnia, pneumothorax, subcutaneous emphysema, and pneumomediastinum

Arms & Interventions

Effect of recruitment maneuver on intracranial pressure

Experimental

A recruitment maneuver will be performed in patients with decreased oxygen saturation due to atelectasis by applying 30 cm H2O positive pressure support for 30 seconds. The effect of the recruitment maneuver on intracranial pressure will be investigated by measuring the optic nerve sheath diameter with the help of ultrasonography before and after the recruitment maneuver.

Intervention: The recruitment maneuver (Diagnostic Test)

Outcomes

Primary Outcomes

Effect of recruitment maneuver on optic nerve sheath diameter (ONSD)

Time Frame: 1 minute

Change in optic nerve sheath diameter (ONSD) after the recruitment maneuver in acute respiratory distress syndrome (ARDS) patients

Secondary Outcomes

  • Effect of recruitment maneuver on oxygen saturation (SpO2)(10 minute)
  • The effect of change of respiratory compliance (Cdyn) on optic nerve sheath diameter (ONSD) after the recruitment maneuver(10 minute)
  • Effect of recruitment maneuver on respiratory compliance (Cdyn)(10 minute)

Investigators

Sponsor
Ondokuz Mayıs University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ozgur Komurcu

Assistant professor

Ondokuz Mayıs University

Study Sites (1)

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