Ventilator Settings on Patients With Acute Brain Injury

Ventilator-Induced Lung Injury Clinical Trial

Official title:

Relation Between Lung Protective Mechanical Ventilation, Intracranial Pressure, Autoregulation and Brain Oxygenation in Neurointensive Care Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03278769
• Other study ID #: Brain-Vent
• Status: Completed
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: January 1, 2022

Study information

• Verified date: May 2022
• Source: University Hospital of North Norway
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The present study is an explorative analysis of the relationship between cerebral blood perfusion and oxygenation and lung mechanical variables at different ventilator settings. It is a safety study excluding patients with severe lung injury or brain edema.

Description:

The primary goal is to carry out baseline measurements to enable conclusions concerning the safety of lung protective ventilator settings before extending the study to patients with more severe brain and/or lung injury in the future.

The primary objective is to investigate if lung protective ventilator settings (higher Positive end-expiratory pressure and lower tidal volume) as compared with conventional settings.

1. increase intracranial pressure

2. diminish cerebral vasoreactive autoregulation as assessed by pressure reactivity index, ie pressure reactivity index will turn positive, which means that it will change the state from intact to impaired autoregulation.

The secondary objective is an exploratory analysis of the relationship between ventilator settings and other well defined respiratory, cerebral, and cardiovascular variables, including transpulmonary pressure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: January 1, 2022
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• • Any tracheally intubated or tracheotomized adult patient with ABI with GCS< 9 on controlled ventilation requiring continuous ICP measurement.

• Proxy informed consent from relatives.

Exclusion Criteria:

• • ICP > 22 mmHg before treatment of high ICP

• Acute respiratory failure defined as partial pressure of oxygen/ inspiratory oxygen fraction (PaO2/FiO2) ratio < 40 kPa and Xray pathology

• History of pulmonary disese: Chronic respiratory failure diagnosis stage III and IV in the GOLD classification, pulmectomy, lobectomy or restrictive lung disease.

• Body mass index (BMI) > 35.

• Known right or biventricular cardiac failure with cardiac index < 2,5 L/min/m2 or ejection fracture < 40 %.

• Refractory hypovolemia as diagnosed with pulse pressure variation > 12 % with tidal volume 8 ml/predicted bodyweight (intubated on controlled ventilation) or passive leg rise test with > 10 % increase in stroke volume measured by VTI echocardiography or PICCO.

• Medulla lesion that affect the autonomic nervous system.

• Patients who has undergone decompressive craniectomy.

Related Conditions & MeSH terms

• Acute Brain Injury
• Brain Injuries
• Cerebrovascular Circulation
• Lung Injury
• Ventilator-Induced Lung Injury
• Wounds and Injuries

Intervention

Procedure:
• Lung protective ventilator settings
Positive end-expiratory pressure 12, Tidal volume 6 milliliter/kilogram predicted body weight

Locations

Country	Name	City	State
Norway	University Hospital North Norway	Tromsø	Troms

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital of North Norway	Cambridge University Hospitals NHS Foundation Trust, Hôpital de la Croix-Rousse

Country where clinical trial is conducted

Norway, 

References & Publications (3)

Koutsoukou A, Katsiari M, Orfanos SE, Kotanidou A, Daganou M, Kyriakopoulou M, Koulouris NG, Rovina N. Respiratory mechanics in brain injury: A review. World J Crit Care Med. 2016 Feb 4;5(1):65-73. doi: 10.5492/wjccm.v5.i1.65. eCollection 2016 Feb 4. Review. — View Citation

Mauri T, Yoshida T, Bellani G, Goligher EC, Carteaux G, Rittayamai N, Mojoli F, Chiumello D, Piquilloud L, Grasso S, Jubran A, Laghi F, Magder S, Pesenti A, Loring S, Gattinoni L, Talmor D, Blanch L, Amato M, Chen L, Brochard L, Mancebo J; PLeUral pressure working Group (PLUG-Acute Respiratory Failure section of the European Society of Intensive Care Medicine). Esophageal and transpulmonary pressure in the clinical setting: meaning, usefulness and perspectives. Intensive Care Med. 2016 Sep;42(9):1360-73. doi: 10.1007/s00134-016-4400-x. Epub 2016 Jun 22. Review. — View Citation

Smielewski P, Lavinio A, Timofeev I, Radolovich D, Perkes I, Pickard JD, Czosnyka M. ICM+, a flexible platform for investigations of cerebrospinal dynamics in clinical practice. Acta Neurochir Suppl. 2008;102:145-51. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intracranial pressure	intracranial pressure increase with lung protective setting	120 minutes
Primary	pressure reactivity index	Diminished pressure reactivity index	120 minutes