The Cerebral-Respiratory Interaction During Spontaneous Breathing Ventilation in Neurosurgical Patients (CeRes-SB)

NCT ID: NCT05363098

Last Updated: 2022-05-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-31
• Study Completion Date: 2023-05-31

Brief Summary

Mechanical ventilation (MV) is a life-saving supportive therapy and one of the most common interventions implemented in intensive care.

To date, only the inspiratory phase of breathing has been extensively investigated, and new MV methods have been implemented to reduce its harmful effects. Despite this, lung injury still occurs and propagates, causing multiorgan failure and patient deaths. The expiratory phase is considered unharmful and is not monitored or assisted during MV. In animal experiments, we recently showed that the loss of diaphragmatic contraction during expiration can harm the lungs during MV. During mechanical ventilation, the expiratory phase of breathing is completely disregarded. However, in all conditions that promote lung collapse, peripheral airways gradually compress and close throughout the expiration, potentially worsening lung injury.

This cyclical lung collapse and consequent air-trapping may have an impact on the Starling resistor mechanisms that regulate venous return from the brain, potentially affecting cerebral perfusion and intracranial pressure.

This study will investigate the incidence and the consequences of an uncontrolled expiration and expiratory lung collapse in spontaneously breathing critically ill neurosurgical patients during 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, on a daily bases during assisted mechanical ventilation.

Conditions

Mechanical Ventilation Complication; Neurological Complication; Respiratory Complication

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Mechanically ventilated neurosurgical patients

Observational study in mechanically ventilated neurosurgical patients

Mechanically ventilated neurosurgical patients

Intervention Type: OTHER

Observational study where respiratory variables and intracranial pressure will be measured during assisted mechanical ventilation. No intervention is planned.

Interventions

Mechanically ventilated neurosurgical patients

Observational study where respiratory variables and intracranial pressure will be measured during assisted mechanical ventilation. No intervention is planned.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uppsala University

OTHER

Sponsor Role: lead

Responsible Party

Mariangela Pellegrini

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mariangela Pellegrini, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Uppsala University Hospital, Uppsala University

Central Contacts

Mariangela Pellegrini, MD, PhD

Role: CONTACT

mariangela.pellegrini@surgsci.uu.se

+460186110000

Other Identifiers

CeRes-SB

Identifier Type: -

Identifier Source: org_study_id