The Cerebral-Respiratory Interaction in Controlled Mechanically Ventilated Neurosurgical Patients. (The CeRes-CMV Study)
NCT ID: NCT05363085
Last Updated: 2022-05-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
30 participants
OBSERVATIONAL
2022-05-31
2023-05-31
Brief Summary
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The effects of airway pressure on intracranial pressure can depend on several factors, and among others, an uncontrolled expiration and consequent lung collapse may have an influence on cerebral perfusion.
This study will investigate the incidence and the consequences of an uncontrolled expiration and expiratory lung collapse in critically ill neurosurgical patients during controlled mechanical ventilation.
Electrical impedance tomography measurements , oesophagus and gastric pressure, electrical activity of the diaphragm and intracranial pressure will be acquired in a synchronised manner during controlled mechanical ventilation. Moreover, airway opening pressure, expiratory flow limitation and recruitment/inflation ratio will be determined during controlled mechanical ventilation, on a daily bases until the patient recover his/her own spontaneous breathing.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Mechanically ventilated neurosurgical patients
Observational study in mechanically ventilated neurosurgical patients
Mechanically ventilated neurosurgical patients
Observational study where respiratory variables and intracranial pressure will be measured during mechanical ventilation and during specific respiratory manoeuvres. No intervention is planned.
Interventions
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Mechanically ventilated neurosurgical patients
Observational study where respiratory variables and intracranial pressure will be measured during mechanical ventilation and during specific respiratory manoeuvres. No intervention is planned.
Eligibility Criteria
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Inclusion Criteria
* MV expected for more than 72 hours;
* Not pregnant;
* Informed consent from patient or next of kin.
Exclusion Criteria
* Chest tube,
* Patients with clinical conditions that contraindicate the insertion of esophageal/gastric catheters (e.g., esophagus rupture, esophageal bleeding),
* Pacemaker and/or implantable cardioverter defibrillator, these last being a contraindication for EIT.
* Hemicraniectomy. In case of late hemicraniectomy (after patient inclusion), the patient will drop-out from the study.
Relative contraindication: in case of skull base fracture the patient can be included only if oesophageal/gastric and NAVA catheters can be inserted orally.
18 Years
ALL
No
Sponsors
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Uppsala University
OTHER
Responsible Party
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Mariangela Pellegrini
Principal Investigator
Principal Investigators
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Mariangela Pellegrini, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Uppsala University Hospital, Uppsala University
Central Contacts
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References
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Bencze R, Kawati R, Hanell A, Lewen A, Enblad P, Engquist H, Bjarnadottir KJ, Joensen O, Barrueta Tenhunen A, Freden F, Brochard L, Perchiazzi G, Pellegrini M. Intracranial response to positive end-expiratory pressure is influenced by lung recruitability and gas distribution during mechanical ventilation in acute brain injury patients: a proof-of-concept physiological study. Intensive Care Med Exp. 2025 Apr 14;13(1):43. doi: 10.1186/s40635-025-00750-y.
Other Identifiers
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CeRes-CMV
Identifier Type: -
Identifier Source: org_study_id
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