Mechanical Ventilation ComplicationCeRes-SBNCT05363098
The Cerebral-Respiratory Interaction During Spontaneous Breathing Ventilation in Neurosurgical Patients (CeRes-SB)
An observational study of Mechanical Ventilation Complication and Neurological Complication, run by Uppsala University.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation Complication, Neurological Complication, Respiratory Complication
- What is being tested?
- Mechanically ventilated neurosurgical patients
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- May 2022to May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Age >18 years;
- MV expected for more than 72 hours;
- Not pregnant;
- Informed consent from patient or next of kin.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read more
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.
- Being tested
- Mechanically ventilated neurosurgical patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanically ventilated neurosurgical patientsOther
Observational study where respiratory variables and intracranial pressure will be measured during assisted mechanical ventilation. No intervention is planned.
| Study group | Role | What they receive |
|---|---|---|
| Mechanically ventilated neurosurgical patients | Observational study in mechanically ventilated neurosurgical patients Receives: Other: Mechanically ventilated neurosurgical patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
Correlation between lung collapse and LOS
Measured: At ICU/hospital discharge, an average of 30 days
Number of days of mechanical ventilation
Correlation between lung collapse and days of mechanical ventilation
Measured: At ICU discharge, an average of 20 days
90-days mortality from intensive care unit admission
Correlation between lung collapse and 90-days mortality
Measured: 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)
Measured: 90 days after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study startMay 2022 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Ventilation ComplicationStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariangela Pellegrini, Uppsala University
- Investigators
- Mariangela Pellegrini, MD, PhD, Principal investigator, Uppsala University Hospital, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05363098
- Sponsor's protocol ID
- CeRes-SB
- Acronym
- CeRes-SB
- Status last verified
- May 2022
- First submitted
- 27 Apr 2022
- Last updated
- 5 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of Expiratory Flow Limitation and the Effects of Spontaneous Breathing on Intracranial Pressure. An Observational Clinical Study on Neurosurgical Patients.
- ClinicalTrials.gov ID
- NCT05363098
- Acronym / sponsor ID
- CeRes-SB / CeRes-SB
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- May 2022 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 5 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mechanically ventilated neurosurgical patients | – | Other: Mechanically ventilated neurosurgical patientsObservational study in mechanically ventilated neurosurgical patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- Age >18 years;
- MV expected for more than 72 hours;
- Not pregnant;
- Informed consent from patient or next of kin.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mechanically ventilated neurosurgical patientsObservational study where respiratory variables and intracranial pressure will be measured during assisted mechanical ventilation. No intervention is planned. | Other | Mechanically ventilated neurosurgical patients |
Primary outcome
Incidence of uncontrolled expiration
Time frame: during the period of assisted mechanical ventilation, an average of 14 days
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.
Correlation between uncontrolled expiration and intracranial pressure
Time frame: During the period of assisted mechanical ventilation, an average of 14 days
The influence of an uncontrolled expiration (defined by expiratory flow, expiratory EAdi and thoracic impedance) on intracranial pressure in neurosurgical patients.
4 secondary outcomes
Intensive care unit (ICU) and hospital length of stay (LOS)
Time frame: At ICU/hospital discharge, an average of 30 days
Number of days of mechanical ventilation
Time frame: At ICU discharge, an average of 20 days
90-days mortality from intensive care unit admission
Time frame: 90 days after hospital discharge
30-day and 90-days neurological and functional outcomes
Time frame: 90 days after hospital discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariangela Pellegrini, MD, PhD principal investigator
Uppsala University Hospital, Uppsala University
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Ventilation Complication and Neurological Complication, run by Uppsala University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mariangela Pellegrini, MD, PhD (+460186110000, mariangela.pellegrini@surgsci.uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of uncontrolled expiration (time frame: during the period of assisted mechanical ventilation, an average of 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2022.