Evaluation of Intracranial Pressure During Mechanical Ventilation Recruitment Maneuver

Not Applicable

Completed

• Conditions: Effect of Recruitment Maneuver on Intracranial Pressure
• Interventions: Diagnostic Test: The recruitment maneuver

• Registration Number: NCT04935008
• Lead Sponsor: Ondokuz Mayıs University

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 Timeline

• Study First Submitted: 2021-06-10
• Study First Submitted QC: 2021-06-14
• Study First Posted: 2021-06-22
• Study Start: 2021-07-01
• Primary Completion: 2022-01-01
• Study Completion: 2022-02-16
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-08
• Last Update Posted: 2022-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Effect of recruitment maneuver on intracranial pressure	The recruitment maneuver	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.

Primary Outcome Measures

Name	Time	Method
Effect of recruitment maneuver on optic nerve sheath diameter (ONSD)	1 minute	Change in optic nerve sheath diameter (ONSD) after the recruitment maneuver in acute respiratory distress syndrome (ARDS) patients

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ondokuz Mayıs Üniversitesi; 🇹🇷 Samsun, Turkey