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

Investigating the Effects of Expiratory Flow Limitation and the Effects of Spontaneous Breathing on Intracranial Pressure. An Observational Clinical Study on Neurosurgical Patients.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Mechanical Ventilation Complication; Respiratory Complication; Neurological Complication
• Intervention / Treatment: Other: Mechanically ventilated neurosurgical patients

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Mariangela Pellegrini, MD, PhD; Phone Number: +460186110000; Email: mariangela.pellegrini@surgsci.uu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

Neurosurgical patients on mechanical ventilation and with ongoing intracerebral pressure monitoring will be included in the study

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Mechanically ventilated neurosurgical patients; Observational study in mechanically ventilated neurosurgical patients	Other: Mechanically ventilated neurosurgical patients; Observational study where respiratory variables and intracranial pressure will be measured during assisted mechanical ventilation. No intervention is planned.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of days of mechanical ventilation	Correlation between lung collapse and days of mechanical ventilation	At ICU discharge, an average of 20 days
90-days mortality from intensive care unit admission	Correlation between lung collapse and 90-days mortality	90 days after hospital discharge
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
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

Collaborators and Investigators

• Sponsor: Uppsala University
• Investigators: Principal Investigator: Mariangela Pellegrini, MD, PhD, Uppsala University Hospital, Uppsala University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2022
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: April 27, 2022
• First Submitted That Met QC Criteria: May 2, 2022
• First Posted (Actual): May 5, 2022

Study Record Updates

• Last Update Posted (Actual): May 5, 2022
• Last Update Submitted That Met QC Criteria: May 2, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: CeRes-SB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No