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| Name | Class |
|---|---|
| Cambridge University Hospitals NHS Foundation Trust | OTHER |
| Hôpital de la Croix-Rousse | OTHER |
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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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ventilator setting | Experimental | Positive end-expiratory pressure , Tidal volume |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lung protective ventilator settings | Procedure | Positive end-expiratory pressure 12, Tidal volume 6 milliliter/kilogram predicted body weight |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intracranial pressure | intracranial pressure increase with lung protective setting | 120 minutes |
| pressure reactivity index | Diminished pressure reactivity index | 120 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shirin K Frisvold | University Hospital of North Norway | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital North Norway | Tromsø | Troms | 9010 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19388307 | Background | 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. doi: 10.1007/978-3-211-85578-2_30. | |
| 26855895 | Background | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 1, 2019 | May 16, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D055397 | Ventilator-Induced Lung Injury |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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| 27334266 | Background | 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. |
| 36941683 | Derived | Beqiri E, Smielewski P, Guerin C, Czosnyka M, Robba C, Bjertnaes L, Frisvold SK. Neurological and respiratory effects of lung protective ventilation in acute brain injury patients without lung injury: brain vent, a single centre randomized interventional study. Crit Care. 2023 Mar 20;27(1):115. doi: 10.1186/s13054-023-04383-z. |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |