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

NCT05363098 | Unknown

• 1 other identifier: CeRes-SB
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• Incidence of uncontrolled expiration

  The incidence of uncontrolled expiration and consequent expiratory lung collapse (determined by changes in expiratory flow and time constant) during assisted ventilation in neurosurgical patients.

  during the period of assisted mechanical ventilation, an average of 14 days

• Correlation between uncontrolled expiration and intracranial pressure

  The influence of an uncontrolled expiration (defined by expiratory flow, expiratory EAdi and thoracic impedance) on intracranial pressure in neurosurgical patients.

  During the period of assisted mechanical ventilation, an average of 14 days

Secondary Outcomes (4)

• Intensive care unit (ICU) and hospital length of stay (LOS)

  At ICU/hospital discharge, an average of 30 days

• Number of days of mechanical ventilation

  At ICU discharge, an average of 20 days

• 90-days mortality from intensive care unit admission

  90 days after hospital discharge

• 30-day and 90-days neurological and functional outcomes

  90 days after hospital discharge

Study Arms (1)

Mechanically ventilated neurosurgical patients

Observational study in mechanically ventilated neurosurgical patients

Other: Mechanically ventilated neurosurgical patients

Interventions

Mechanically ventilated neurosurgical patients OTHER

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

Mechanically ventilated neurosurgical patients

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Patients recruitment will be kept equally distributed between sexes.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Age \>18 years;
• MV expected for more than 72 hours;
• Not pregnant;
• Informed consent from patient or next of kin.

You may not qualify if:

• 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;
• Relative contraindication: in case of skull base fracture the patient can be included only if oesophageal/gastric and NAVA catheters can be inserted orally.

Sponsors & Collaborators

• Uppsala University: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood gas analysis sampled daily shortly before respiratory mechanics data recording

Study Officials

• Mariangela Pellegrini, MD, PhD

  Uppsala University Hospital, Uppsala University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariangela Pellegrini, MD, PhD

CONTACT

+460186110000; mariangela.pellegrini@surgsci.uu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: May 5, 2022
• Study Start: May 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: May 1, 2023
• Last Updated: May 5, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share