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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05363098
Other study ID # CeRes-SB
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

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.


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 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Mechanically ventilated neurosurgical patients
Observational study where respiratory variables and intracranial pressure will be measured during assisted mechanical ventilation. 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 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
Primary 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 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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