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

NCT05363085 | Unknown

• 1 other identifier: CeRes-CMV
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Mechanical Ventilation Complication; Neurological Disorder; Lung Injury

Outcome Measures

Primary Outcomes (3)

• The incidence of lung collapse

  The incidence of an uncontrolled expiration and consequent expiratory lung collapse (determined by expiratory flow limitation, airway opening pressure and expiratory thoracic impedance) increased chest-wall elastance in neurosurgical patients.

  during the period of controlled mechanical ventilation, an average of 14 days

• Correlation between lung recruitability and intracerebral pressure

  The influence of lung recruitability (determined by recruitment/inflation ratio and changes of thoracic impedance) on intra cerebral pressure in neurosurgical patients.

  during the period of controlled mechanical ventilation, an average of 14 days

• Correlation between lung collapse and intracerebral pressure

  The correlation between an uncontrolled expiration (determined by expiratory flow limitation, airway opening and expiratory thoracic impedance), increased chest-wall elastance and intracranial pressure in neurosurgical patients.

  during the period of controlled mechanical ventilation, an average of 14 days

Secondary Outcomes (4)

• Intensive care unit (ICU) and hospital length of stay (LOS);

  At ICU/hospital discharge, an average of 30 days

• Number of days of mechanical ventilation

  At ICU discharge, an average of 20 days

• 90-days mortality from intensive care unit admission

  90 days after hospital discharge

• 30-day and 90-days neurological and functional outcomes

  90 days after hospital discharge

Study Arms (1)

Mechanically ventilated neurosurgical patients

Observational study in mechanically ventilated neurosurgical patients

Other: Mechanically ventilated neurosurgical patients

Interventions

Mechanically ventilated neurosurgical patients OTHER

Observational study where respiratory variables and intracranial pressure will be measured during mechanical ventilation and during specific respiratory manoeuvres. No intervention is planned.

Mechanically ventilated neurosurgical patients

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Patients recruitment will be kept equally distributed between sexes.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Critically ill adult patients affected by acute brain injury (e.g., subarachnoid hemorrhage, subdural hemorrhage, epidural hemorrhage, traumatic brain injury, intracerebral hemorrhage) admitted to the NICU of Uppsala. Consecutive patients will be prospectively screened for eligibility according to inclusion criteria

You may qualify if:

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

You may not qualify if:

• 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.
• Relative contraindication: in case of skull base fracture the patient can be included only if oesophageal/gastric and NAVA catheters can be inserted orally.

Sponsors & Collaborators

• Uppsala University: lead

Related Publications (1)

• 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.

  PMID: 40229445 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood gas analysis sampled daily shortly before respiratory mechanics data recording

MeSH Terms

Conditions

Nervous System Diseases; Lung Injury

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Thoracic Injuries; Wounds and Injuries

Study Officials

• Mariangela Pellegrini, MD, PhD

  Uppsala University Hospital, Uppsala University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariangela Pellegrini, MD, PhD

CONTACT

+460186110000; mariangela.pellegrini@surgsci.uu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: May 5, 2022
• Study Start: May 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: May 1, 2023
• Last Updated: May 5, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share