Clinical trial NCT04935008: 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
Overall status: COMPLETED
Phase: NA
Conditions: Effect of Recruitment Maneuver on Intracranial Pressure
Keywords: Recruitment maneuver
Intracranial pressure
Optic Nerve Sheath Diameter
Acute respiratory distress syndrome
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2021-06-22
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: all patients in mechanical ventilation
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Effect of recruitment maneuver on optic nerve sheath diameter (ONSD)
timeFrame: 1 minute
Secondary outcomes:
measure: Effect of recruitment maneuver on respiratory compliance (Cdyn)
timeFrame: 10 minute
measure: Effect of recruitment maneuver on oxygen saturation (SpO2)
timeFrame: 10 minute
measure: The effect of change of respiratory compliance (Cdyn) on optic nerve sheath diameter (ONSD) after the recruitment maneuver
timeFrame: 10 minute
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Ondokuz Mayıs Üniversitesi
Study officials:
affiliation: Ondokuz Mayıs University
name: özgür kömürcü, 1
role: STUDY_DIRECTOR
References:
citation: Cortes I, Penuelas O, Esteban A. Acute respiratory distress syndrome: evaluation and management. Minerva Anestesiol. 2012 Mar;78(3):343-57.
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.
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.
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.
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.
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.
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.