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Evaluation of Intracranial Pressure During Mechanical Ventilation Recruitment Maneuver

Primary Purpose

Effect of Recruitment Maneuver on Intracranial Pressure

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
The recruitment maneuver
Sponsored by
Ondokuz Mayıs University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Effect of Recruitment Maneuver on Intracranial Pressure focused on measuring Recruitment maneuver, Intracranial pressure, Optic Nerve Sheath Diameter, Acute respiratory distress syndrome

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ondokuz Mayıs Üniversitesi

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Effect of recruitment maneuver on intracranial pressure

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Effect of recruitment maneuver on respiratory compliance (Cdyn)
Change in respiratory compliance (Cdyn) after the recruitment maneuver
Effect of recruitment maneuver on oxygen saturation (SpO2)
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
Effect of respiratory compliance (Cdyn) change on optic nerve sheath diameter (ONSD) change after recruitment maneuver

Full Information

First Posted
June 10, 2021
Last Updated
March 8, 2022
Sponsor
Ondokuz Mayıs University
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1. Study Identification

Unique Protocol Identification Number
NCT04935008
Brief Title
Evaluation of Intracranial Pressure During Mechanical Ventilation Recruitment Maneuver
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
February 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ondokuz Mayıs University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Effect of Recruitment Maneuver on Intracranial Pressure
Keywords
Recruitment maneuver, Intracranial pressure, Optic Nerve Sheath Diameter, Acute respiratory distress syndrome

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
all patients in mechanical ventilation
Masking
None (Open Label)
Allocation
N/A
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Effect of recruitment maneuver on intracranial pressure
Arm Type
Experimental
Arm Description
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 Type
Diagnostic Test
Intervention Name(s)
The recruitment maneuver
Other Intervention Name(s)
Measurement of optic nerve sheath diameter with the help of ultrasonography
Intervention Description
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.
Primary Outcome Measure Information:
Title
Effect of recruitment maneuver on optic nerve sheath diameter (ONSD)
Description
Change in optic nerve sheath diameter (ONSD) after the recruitment maneuver in acute respiratory distress syndrome (ARDS) patients
Time Frame
1 minute
Secondary Outcome Measure Information:
Title
Effect of recruitment maneuver on respiratory compliance (Cdyn)
Description
Change in respiratory compliance (Cdyn) after the recruitment maneuver
Time Frame
10 minute
Title
Effect of recruitment maneuver on oxygen saturation (SpO2)
Description
Change in oxygen saturation (SpO2) after the recruitment maneuver
Time Frame
10 minute
Title
The effect of change of respiratory compliance (Cdyn) on optic nerve sheath diameter (ONSD) after the recruitment maneuver
Description
Effect of respiratory compliance (Cdyn) change on optic nerve sheath diameter (ONSD) change after recruitment maneuver
Time Frame
10 minute

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
özgür kömürcü, 1
Organizational Affiliation
Ondokuz Mayıs University
Official's Role
Study Director
Facility Information:
Facility Name
Ondokuz Mayıs Üniversitesi
City
Samsun
ZIP/Postal Code
55050
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22357372
Citation
Cortes I, Penuelas O, Esteban A. Acute respiratory distress syndrome: evaluation and management. Minerva Anestesiol. 2012 Mar;78(3):343-57.
Results Reference
background
PubMed Identifier
9445314
Citation
Dreyfuss D, Saumon G. Ventilator-induced lung injury: lessons from experimental studies. Am J Respir Crit Care Med. 1998 Jan;157(1):294-323. doi: 10.1164/ajrccm.157.1.9604014. No abstract available.
Results Reference
background
PubMed Identifier
6105441
Citation
Gattinoni L, Agostoni A, Pesenti A, Pelizzola A, Rossi GP, Langer M, Vesconi S, Uziel L, Fox U, Longoni F, Kolobow T, Damia G. Treatment of acute respiratory failure with low-frequency positive-pressure ventilation and extracorporeal removal of CO2. Lancet. 1980 Aug 9;2(8189):292-4. doi: 10.1016/s0140-6736(80)90237-8.
Results Reference
background
PubMed Identifier
15599138
Citation
Lim SC, Adams AB, Simonson DA, Dries DJ, Broccard AF, Hotchkiss JR, Marini JJ. Intercomparison of recruitment maneuver efficacy in three models of acute lung injury. Crit Care Med. 2004 Dec;32(12):2371-7. doi: 10.1097/01.ccm.0000147445.73344.3a.
Results Reference
background
PubMed Identifier
21858521
Citation
Marini JJ. Recruitment by sustained inflation: time for a change. Intensive Care Med. 2011 Oct;37(10):1572-4. doi: 10.1007/s00134-011-2329-7. Epub 2011 Aug 20. No abstract available.
Results Reference
background
PubMed Identifier
9449727
Citation
Amato MB, Barbas CS, Medeiros DM, Magaldi RB, Schettino GP, Lorenzi-Filho G, Kairalla RA, Deheinzelin D, Munoz C, Oliveira R, Takagaki TY, Carvalho CR. Effect of a protective-ventilation strategy on mortality in the acute respiratory distress syndrome. N Engl J Med. 1998 Feb 5;338(6):347-54. doi: 10.1056/NEJM199802053380602.
Results Reference
background
PubMed Identifier
15693985
Citation
Lapinsky SE, Mehta S. Bench-to-bedside review: Recruitment and recruiting maneuvers. Crit Care. 2005 Feb;9(1):60-5. doi: 10.1186/cc2934. Epub 2004 Aug 18.
Results Reference
background

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Evaluation of Intracranial Pressure During Mechanical Ventilation Recruitment Maneuver

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