Evaluation of Intracranial Pressure During Mechanical Ventilation Recruitment Maneuver

NCT ID: NCT04935008

Last Updated: 2022-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2022-02-16

Brief Summary

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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

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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.

Conditions

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Effect of Recruitment Maneuver on Intracranial Pressure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

all patients in mechanical ventilation
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Effect of recruitment maneuver on intracranial pressure

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.

Group Type EXPERIMENTAL

The recruitment maneuver

Intervention Type 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.

Interventions

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The recruitment maneuver

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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Measurement of optic nerve sheath diameter with the help of ultrasonography

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ondokuz Mayıs University

OTHER

Sponsor Role lead

Responsible Party

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Ozgur Komurcu

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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özgür kömürcü, 1

Role: STUDY_DIRECTOR

Ondokuz Mayıs University

Locations

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Ondokuz Mayıs Üniversitesi

Samsun, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Cortes I, Penuelas O, Esteban A. Acute respiratory distress syndrome: evaluation and management. Minerva Anestesiol. 2012 Mar;78(3):343-57.

Reference Type BACKGROUND
PMID: 22357372 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9445314 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6105441 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15599138 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21858521 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9449727 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15693985 (View on PubMed)

Other Identifiers

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2020/528

Identifier Type: -

Identifier Source: org_study_id

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