The Cerebral-Respiratory Interaction in Controlled Mechanically Ventilated Neurosurgical Patients. (The CeRes-CMV Study)

NCT ID: NCT05363085

Last Updated: 2022-05-05

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-31

Study Completion Date

2023-05-31

Brief Summary

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The impact of mechanical ventilation on intracranial perfusion is still not completely clarified. It is often assumed that raising airway pressure will invariably elevate the intracranial pressure, but this is not always the case.

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.

Detailed Description

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Conditions

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Mechanical Ventilation Complication Neurological Disorder Lung Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Mechanically ventilated neurosurgical patients

Observational study in mechanically ventilated neurosurgical patients

Mechanically ventilated neurosurgical patients

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age \>18 years;
* MV expected for more than 72 hours;
* Not pregnant;
* Informed consent from patient or next of kin.

Exclusion Criteria

* Previously demonstrated paralysis of the diaphragm or know pathology of the phrenic nerve or neuromuscular disorder,
* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Uppsala University

OTHER

Sponsor Role lead

Responsible Party

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Mariangela Pellegrini

Principal Investigator

Responsibility Role 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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Mariangela Pellegrini, MD, PhD

Role: CONTACT

+460186110000

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.

Reference Type DERIVED
PMID: 40229445 (View on PubMed)

Other Identifiers

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CeRes-CMV

Identifier Type: -

Identifier Source: org_study_id

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