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

Mechanical Ventilation Complication Clinical Trial

— CeRes-CMV  

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05363085
• Other study ID #: CeRes-CMV
• Status: Not yet recruiting
• Start date: May 2022
• Est. completion date: May 2023

Study information

• Verified date: May 2022
• Source: Uppsala University
• Contact: Mariangela Pellegrini, MD, PhD
• Phone: +460186110000
• Email: mariangela.pellegrini[@]surgsci.uu.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: May 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Injury
• Mechanical Ventilation Complication
• Nervous System Diseases
• Neurological Disorder

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	Number of days of mechanical ventilation	Correlation between lung collapse and days of mechanical ventilation	At ICU discharge, an average of 20 days
Secondary	90-days mortality from intensive care unit admission	Correlation between lung collapse and 90-days mortality	90 days after hospital discharge
Secondary	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