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Completed

NCT Number: NCT04935008

Evaluation of Intracranial Pressure During Mechanical Ventilation Recruitment Maneuver

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ondokuz Mayıs Üniversitesi

Samsun, 55050, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The recruitment maneuver

Diagnostic Test

In patients with ARDS, 30 cm H2O positive pressure support and 30 seconds recruitment maneuver will be applied. 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. Optic nerve diameter will be evaluated with a linear probe on the eyeball before and after the collection maneuver, taking a value of 3 mm from the eyeball.

Other names: Measurement of optic nerve sheath diameter with the help of ultrasonography

Primary outcomes

  1. 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

  1. Effect of recruitment maneuver on respiratory compliance (Cdyn)

    Time frame: 10 minute

    Change in respiratory compliance (Cdyn) after the recruitment maneuver

  2. Effect of recruitment maneuver on oxygen saturation (SpO2)

    Time frame: 10 minute

    Change in oxygen saturation (SpO2) after the recruitment maneuver

  3. The effect of change of respiratory compliance (Cdyn) on optic nerve sheath diameter (ONSD) after the recruitment maneuver

    Time frame: 10 minute

    Effect of respiratory compliance (Cdyn) change on optic nerve sheath diameter (ONSD) change after recruitment maneuver

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 22, 2021
Registry last updated
Mar 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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