- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01159392
Alveolar Recruitment in Brain Injury
Effects of Recruitment Maneuvers in Patients With Acute Brain Injury and Acute Lung Injury
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Patients with severe brain injury comprise a significant portion of admissions to critical care units. These patients are unable to adequately protect their airways and are usually intubated and mechanically ventilated. The goal of mechanical ventilation in patients with brain injury is to optimize blood gas exchange while minimizing intrathoracic pressure to avoid interference with cerebral venous drainage.Over the last 20 years, a plethora of experimental and clinical data have shown that mechanical ventilation can cause or aggravate lung damage in patients with acute lung injury (ALI) and the acute respiratory distress syndrome (ARDS). The aim of this pilot study was to assess the effects of a single standardized recruitment maneuver (RM) on oxygenation and on systemic and cerebral hemodynamics in severe brain injury patients with ALI/ARDS.
Only patients with brain injury, as defined by a Glasgow Coma Score <13, admitted into the Trauma and Surgical intensive care unit (ICU) will be studied.
After obtaining informed consent, a RM will be performed by switching the ventilator from assist/control ventilation to continuous positive airway pressure (CPAP) and applying a pressure of 40 cmH2O for 40 sec (11). After the RM, patients have been ventilated in pressure control ventilation and PEEP will be gradually reduced in decremental steps every 3 respiratory cycles starting with PEEP at 30 cm H2O, maintaining a maximum peak pressure of 40 cmH2O during this procedure until pre-RM PEEP levels are achieved. The RM will be discontinued if any of the following changes developed during the procedure: (i) ≥20% changes in baseline systemic blood pressure, (ii) ICP ≥20 mmHg, or (iii) SaO2 ≤90%. After the RM is performed, respiratory mechanics, arterial and SjO2 blood samples and systemic and cerebral hemodynamics will be obtained at 30 min and 8 hours.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Barcelona, Spanien, 08036
- Trauma and Surgical ICU, Hospital Clinic
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Patients with brain injury who met the ALI/ARDS criteria within 72 hours after ICU admission
Exclusion Criteria:
- <18 years of age
- Cardiogenic edema
- Hemodynamic instability
- Intracranial hypertension
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
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Brain injury plus acute lung injury
Patients with severe brain injury (Glasgow coma score<13) with acute lung injury (PaO2/FiO2 <300 mmHg)
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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arterial oxygenation
Tidsramme: 8 hours
|
Arterial oxygenation was expressed as PaO2/FiO2 ratio
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8 hours
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
cerebral hemodynamics
Tidsramme: 8 hours
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Cerebral hemodynamics will be assessed by cerebral perfusion pressure and intracranial pressure
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8 hours
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Elizabeth Zavala, MD, PhD, Hospital Clinic, Barcelona, Spain
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RM-0152
- FIS-0152 (Andet bevillings-/finansieringsnummer: Fondo de Investigaciones Sanitarias)
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