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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05363085
Other study ID # CeRes-CMV
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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