Clinical trial NCT05363085: The Cerebral-Respiratory Interaction in Controlled Mechanically Ventilated Neurosurgical Patients. (The CeRes-CMV Study)
Official title: The Effects of Airway Closure, Expiratory Flow Limitation and of a Passive Chest Wall on the Onset of an Uncontrolled Expiration and on Intracranial Pressure. An Observational Clinical Study on Neurosurgical Patients. (The CeRes-CMV Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mechanical Ventilation Complication
Neurological Disorder
Lung Injury
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2022-05-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: The patients will be included within 48 hours from initiation of mechanical ventilation and insertion of an external ventricular drainage catheter

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.

Primary outcomes:
measure: The incidence of lung collapse
timeFrame: during the period of controlled mechanical ventilation, an average of 14 days
measure: Correlation between lung recruitability and intracerebral pressure
timeFrame: during the period of controlled mechanical ventilation, an average of 14 days
measure: Correlation between lung collapse and intracerebral pressure
timeFrame: during the period of controlled mechanical ventilation, an average of 14 days
Secondary outcomes:
measure: Intensive care unit (ICU) and hospital length of stay (LOS);
timeFrame: At ICU/hospital discharge, an average of 30 days
measure: Number of days of mechanical ventilation
timeFrame: At ICU discharge, an average of 20 days
measure: 90-days mortality from intensive care unit admission
timeFrame: 90 days after hospital discharge
measure: 30-day and 90-days neurological and functional outcomes
timeFrame: 90 days after hospital discharge
Other outcomes:
Locations:
Study officials:
affiliation: Uppsala University Hospital, Uppsala University
name: Mariangela Pellegrini, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: