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

• Conditions: Neurological Disorder; Mechanical Ventilation Complication; Lung Injury
• Interventions: Other: Mechanically ventilated neurosurgical patients

• Registration Number: NCT05363085
• Lead Sponsor: Uppsala University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-27
• Status Verified: 2022-05
• Study Start: 2022-05
• Study First Submitted QC: 2022-05-02
• Last Update Submitted: 2022-05-02
• Study First Posted: 2022-05-05
• Last Update Posted: 2022-05-05
• Primary Completion: 2022-12
• Study Completion: 2023-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mechanically ventilated neurosurgical patients	Mechanically ventilated neurosurgical patients	Observational study in mechanically ventilated neurosurgical patients

Primary Outcome Measures

Name	Time	Method
The incidence of lung collapse	during the period of controlled mechanical ventilation, an average of 14 days	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.
Correlation between lung collapse and intracerebral pressure	during the period of controlled mechanical ventilation, an average of 14 days	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.
Correlation between lung recruitability and intracerebral pressure	during the period of controlled mechanical ventilation, an average of 14 days	The influence of lung recruitability (determined by recruitment/inflation ratio and changes of thoracic impedance) on intra cerebral pressure in neurosurgical patients.

Secondary Outcome Measures

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