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

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)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Injury; Mechanical Ventilation Complication; Neurological Disorder
• Intervention / Treatment: Other: Mechanically ventilated neurosurgical patients

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Mariangela Pellegrini, MD, PhD; Phone Number: +460186110000; Email: mariangela.pellegrini@surgsci.uu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Mechanically ventilated neurosurgical patients; Observational study in mechanically ventilated neurosurgical patients	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensive care unit (ICU) and hospital length of stay (LOS);	Correlation between lung collapse and LOS	At ICU/hospital discharge, an average of 30 days
Number of days of mechanical ventilation	Correlation between lung collapse and days of mechanical ventilation	At ICU discharge, an average of 20 days
90-days mortality from intensive care unit admission	Correlation between lung collapse and 90-days mortality	90 days after hospital discharge
30-day and 90-days neurological and functional outcomes	Correlation between lung collapse and 30-day and 90-days neurological and functional outcomes (Disability Rating Scale, clinical frailty score, Glasgow Outcome Scale)	90 days after hospital discharge

Collaborators and Investigators

• Sponsor: Uppsala University
• Investigators: Principal Investigator: Mariangela Pellegrini, MD, PhD, Uppsala University Hospital, Uppsala University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2022
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: April 27, 2022
• First Submitted That Met QC Criteria: May 2, 2022
• First Posted (Actual): May 5, 2022

Study Record Updates

• Last Update Posted (Actual): May 5, 2022
• Last Update Submitted That Met QC Criteria: May 2, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Wounds and Injuries; Thoracic Injuries; Nervous System Diseases; Lung Injury
• Other Study ID Numbers: CeRes-CMV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No