Isoflurane for Intracranial hemorrhage | Severe traumatic brain injury | Ischemic stroke | Hemorrhagic stroke

Inclusion criteria

• {"criterion_text":"- Patients equal or older than 18 years old\n- Neurocritical patients (intracranial hemorrhage, severe traumatic brain injury, ischemic or hemorrhagic stroke) who, due to their clinical situation and by decision of the treating physician, require advanced neurological monitoring (ICP catheter, DTC...) and deep sedation Intensive Unit Care admission\n- Informed consent form signed by a family member/legal representative"}

Exclusion criteria

• {"criterion_text":"- Neurocritical patients with risk of CTEH (by imaging techniques) who do not have ICP catheter monitoring\n- End-of-life situation or with ICU admission oriented towards donation\n- Refusal to informed consent by the relative/legal representative of reference.\n- Neurocritical patients monitored with an ICP catheter but with initial values >20 mmHg\n- Neurocritical patients with decompressive craniectomy monitored with an ICP catheter and with initial values ​​>13 mmHg.\n- Severe hypoxemia (pO2<60mmHg) or high FiO2 requirements (>0.6) and/or high PEEP values (>10mmHg).\n- Patients in shock who require vasoactive support with noradrenaline >0.5mcg/kg/min and/or lactate >2. 5mmol/L.\n- Patients who, upon admission, in the initial neurological evaluation with transcranial Doppler, have a negative Giller Test (loss of cerebral self-regulation).\n- Patients under 18 years of age.\n- Pregnant or breastfeeding patients.\n- Patients with any contraindication to the administration of isoflurane"}

Primary endpoints

• {"endpoint_text":"- Sedation variables: RASS scale, Bispectral Index (BIS), Delta BIS index, required doses of intravenous or inhalation sedation during the study period, Placement of the Sedaconda device: in the mouth or on the inspiratory branch, recording of the ISOef value (expiratory fraction gas) during the study period. The upper permitted ISOef limit will be set at 1%. Respiratory, hemodynamic variables, neuromomitorization and infectious status","definition_or_measurement_approach":"Measured using RASS scale, BIS and Delta BIS index monitoring; recording required doses of IV or inhalation sedation; recording placement of Sedaconda device (mouth or inspiratory branch); recording ISOef (expiratory gas fraction) with an upper permitted ISOef limit of 1%; monitoring respiratory and hemodynamic parameters, neuromonitoring measures and infectious status throughout study period."}

Secondary endpoints

• {"endpoint_text":"- Adverse effects observed throughout the study. • Awakening time and presence/absence of delirium in this patient awakening process. • Alteration of liver function throughout the study. • Alteration of kidney function throughout the study. • Days spent in ICU. • Days spent in the hospital. • Mortality in ICU. • Hospital mortality","definition_or_measurement_approach":"Adverse effects collected/recorded throughout study; awakening time and presence/absence of delirium assessed during patient awakening (BIS monitoring referenced elsewhere); liver and kidney function assessed by laboratory measures recorded over study; days in ICU/hospital counted; ICU and hospital mortality recorded."}
• {"endpoint_text":"- Data based on analgesia will be collected: Values ​​obtained with NOL (Annex 9). The value indicates the degree of nociception and the required doses of intravenous opioids during the study period.","definition_or_measurement_approach":"Analgesia-related data collected via NOL device values indicating degree of nociception, and recording required doses of intravenous opioids during study period."}

Spain

Earliest CTIS Part Ii Submission Date

20-02-2024

Latest Decision Or Authorization Date

05-08-2024

Processing Time Days

167

Number Of Sites

1

Number Of Participants

24

Primary sponsor

Full Name

Hospital Universitari De Girona Doctor Josep Trueta

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Spain