Brain InjuriesABIVENTNCT04013698
Influence of Respiratory Mechanics on Brain-specific Monitoring in Brain-injured Patients
A study testing PEEP level 5 cmH2O and PEEP level 15 cmH2O in people with Brain Injuries, run by Piquilloud Imboden Lise at 1 site in Switzerland.
Trial summary
Increase in intracranial pressure (ICP) could be associated with increase in positive end-expiratory pressure (PEEP) level. Data are however disparate and interactions between ventilation with high PEEP and intracranial circulation are still debated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injuries
- What is being tested?
- PEEP level 5 cmH2O and PEEP level 15 cmH2O
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Aug 2019to 2 Nov 2020
- Phase
- Interventional
- 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
Who may be able to join
- Acute brain injury of any etiology requiring multimodal brain monitoring (intraparenchymal intracranial pressure, brain-tissue oxygen tension and cerebral microdialysis)
- Controlled mechanical ventilation via endotracheal tube
- Patient needing deep sedation
Who cannot join
- pregnancy
- contraindications to nasogastric probe placement: basilar skull or significant naso-facial fractures, significant esophageal or gastric trauma or bleeding, previous esophageal surgery, significant bleeding diathesis (spontaneous aPTT > 60 sec, PT < 40%, INR > 1.8, platelets < 50000/mm3), known esophageal or gastric varices
- decompressive craniectomy
- intracranial pressure monitoring method other than intraparenchymal (e.g. connected to external ventricular drain)
- severe relevant physiological instability contraindicating an increase in PEEP: severe baseline intracranial pressure elevation (> 20 mmHg), severe hemodynamic instability (defined as norepinephrine requirements > 0.5 μg/kg/min or cardiogenic shock, defined as any use of dobutamine)
- conditions that interfere with accurate measurements of respiratory mechanics: bronchopleural fistula, pneumothorax.
- Withhold of life-sustaining therapy for medical reasons
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Lausanne University Hospitals
Lausanne, Canton of Vaud, 1011
About this study
Official title: Effects of Chest Wall and Lung Elastances on Intracranial Pressure and Brain-specific Multimodal Monitoring in Ventilated Brain Injured Patients
Increase in intracranial pressure (ICP) could be associated with increase in positive end-expiratory pressure (PEEP) level. Data are however disparate and interactions between ventilation with high PEEP and intracranial circulation are still debated. Individual patient's chest wall elastance could have a key role in determining the effects of PEEP on ICP, since it dictates which proportion of the applied PEEP is transmitted to the pleural space, thus increasing central venous pressure (CVP) and reducing cerebral venous return. Measurement of esophageal pressure with a dedicated probe allows partitioning of respiratory system elastance into its lung and chest wall components, thus permitting to study this phenomenon. Multimodal intracranial monitoring permits to study the effects of PEEP on more advanced brain-specific indices such as brain tissue oxygen (PtiO2), cerebral microdialysis data, transcranial doppler ultrasound-derived flow measurements and automated pupillometry, besides ICP.
This study aims to test the association between the ratio of chest wall to respiratory system elastance and PEEP-induced variations in ICP and brain-specific multimodal monitoring indices. This study will evaluate the relative role of other selected measures of respiratory mechanics, hemodynamic variables and intracranial compliance, in order to establish the role of individual respiratory mechanics in the interplay of physiological factors affecting the effects of positive pressure ventilation on the brain.
Patients will undergo two periods of ventilation at two different levels of PEEP (5 and 15 cmH2O) in a randomized cross-over order. At the end of each period, cardiorespiratory clinical data, ICP and other advanced multimodal neuromonitoring data (brain tissue oxygen tension, cerebral microdyalisis analytes, transcranial doppler ultrasound and automated infrared pupillometry data) will be collected. Systematic respiratory mechanics assessment (including calculation of chest wall and lung elastances and estimation of the amount of recruitment versus overdistension due to PEEP by means of a single-breath derecruitment trial), echocardiography and arterial blood gas analysis will be performed.
- Conditions
- Brain Injuries
- Being tested
- PEEP level 5 cmH2O, PEEP level 15 cmH2O
- Keywords
- ventilation, brain injuries, PEEP, esophageal pressure
- Medical subject headings
- Brain Injuries, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEP level 5 cmH2OOther
PEEP level set for 45 minutes
PEEP level 15 cmH2OOther
PEEP level set for 45 minutes
| Study group | Role | What they receive |
|---|---|---|
| PEEP level 5 cmH2O to 15 cmH2O | Experimental | Not described Receives: Other: PEEP level 5 cmH2O; Other: PEEP level 15 cmH2O |
| PEEP level 15 cmH2O to 5 cmH2O | Experimental | Not described Receives: Other: PEEP level 5 cmH2O; Other: PEEP level 15 cmH2O |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between Ers/Ecw and change in ICP between the two PEEP levels
Respiratory mechanics; intracranial pressure monitoring
Ers/Ecw = chest wall to respiratory system elastances ratio; ICP = intracranial pressure
Measured: Recorded every minute during 10 minutes at the end of each 45-minute period (PEEP 5 and 15 cmH2O), 90 minutes
Secondary outcomes (19)
Correlation between Ecw/Ers and the following neuromonitoring indices at the two PEEP levels: PtiO2, LPR, NPI; MFV, DFV and PI.
Respiratory mechanics; brain tissue oxygen tension; cerebral microdyalisis analytes; automated infrared pupillometry; transcranial doppler ultrasound
Ers/Ecw = chest wall to respiratory system elastances ratio; PtiO2 = brain tissue oxygen tension; LPR = lactate/pyruvate ratio; NPI = neurological pupil index; MFV = mean flow velocity; DFV = diastolic flow velocity; PI = pulsatility index
Measured: Recorded every minute during 10 minutes at the end of each 45-minute period (PEEP 5 and 15 cmH2O), 90 minutes
Effect of the two different levels of PEEP on NPI.
Automated infrared pupillometry
NPI = neurological pupil index
PtiO2 = brain tissue oxygen tension; LPR = lactate/pyruvate ratio; NPI = neurological pupil index
Measured: Recorded every minute during 10 minutes at the end of each 45-minute period (PEEP 5 and 15 cmH2O), 90 minutes
Effect of the two different levels of PEEP on the following transcranial doppler ultrasound variables: MFV, DFV and PI.
Transcranial doppler ultrasound
MFV = mean flow velocity; DFV = diastolic flow velocity; PI = pulsatility index
Measured: Recorded every minute during 10 minutes at the end of each 45-minute period (PEEP 5 and 15 cmH2O), 90 minutes
Effect of the two different levels of PEEP on LPR.
Cerebral microdyalisis analytes
LPR = lactate/pyruvate ratio
Measured: Recorded every minute during 10 minutes at the end of each 45-minute period (PEEP 5 and 15 cmH2O), 90 minutes
Effect of the two different levels of PEEP on PtiO2.
Brain tissue oxygen tension.
PtiO2 = brain tissue oxygen tension
Measured: Recorded every minute during 10 minutes at the end of each 45-minute period (PEEP 5 and 15 cmH2O), 90 minutes
Effect of the two different levels of PEEP on the following intravascular pressures: CVP, MAP, CPP.
Invasive intravascular pressures.
CVP = central venous pressure; MAP = mean arterial pressure; CPP = cerebral perfusion pressure
Measured: Recorded every minute during 10 minutes at the end of each 45-minute period (PEEP 5 and 15 cmH2O), 90 minutes
Effect of the two different levels of PEEP on the following echocardiographic measurements: LVOT VTI, CO.
Echocardiography.
LVOT VTI = left ventricle outflow tract velocity-time integral; CO = cardiac output (echocardiographically estimated).
Measured: Recorded every minute during 10 minutes at the end of each 45-minute period (PEEP 5 and 15 cmH2O), 90 minutes
Effect of the two different levels of PEEP on the dose of vasopressors/inotropes and volume of fluid boluses administered.
Administered drugs and fluids.
Measured: Recorded every minute during 10 minutes at the end of each 45-minute period (PEEP 5 and 15 cmH2O), 90 minutes
Correlation between Ers/Ecw and the following parameters at the two PEEP levels: LVOT VTI, CO; CVP, MAP, CPP; dose of vasopressors/inotropes and volume of fluid boluses administered.
Respiratory mechanics; echocardiography; invasive intravascular pressures; administered drugs and fluids
LVOT VTI = left ventricle outflow tract velocity-time integral; CO = cardiac output (echocardiographically estimated); CVP = central venous pressure; MAP = mean arterial pressure; CPP = cerebral perfusion pressure
Measured: Recorded every minute during 10 minutes at the end of each 45-minute period (PEEP 5 and 15 cmH2O), 90 minutes
Correlation between Pes_end-exp and the following parameters at the two PEEP levels: ICP, PtiO2, LPR, NPI, MFV, DFV, PI; CVP, MAP, CPP, LVOT VTI, CO, dose of vasopressors/inotropes and volume of fluid boluses administered.
Respiratory mechanics; intracranial pressure monitoring, Brain tissue oxygen tension; cerebral microdyalisis analytes; automated infrared pupillometry; transcranial doppler ultrasound; Echocardiography; invasive intravascular pressures; administered drugs and fluids.
ICP = intracranial pressure; PtiO2 = brain tissue oxygen tension; LPR = lactate/pyruvate ratio; NPI = neurological pupil index; MFV = mean flow velocity; DFV = diastolic flow velocity; PI = pulsatility index; CVP = central venous pressure; MAP = mean arterial pressure; CPP = cerebral perfusion pressure; LVOT VTI = left ventricle outflow tract velocity-time integral; CO = cardiac output (echocardiographically estimated)
Measured: Recorded every minute during 10 minutes at the end of each 45-minute period (PEEP 5 and 15 cmH2O), 90 minutes
Correlation between Rec/PEEPvol and the following parameters at the two PEEP levels: ICP, PtiO2, LPR, NPI, MFV, DFV, PI; CVP, MAP, CPP, LVOT VTI, CO, dose of vasopressors/inotropes and volume of fluid boluses administered.
Respiratory mechanics; intracranial pressure monitoring, Brain tissue oxygen tension; cerebral microdyalisis analytes; automated infrared pupillometry; transcranial doppler ultrasound; Echocardiography; invasive intravascular pressures; administered drugs and fluids.
Rec/PEEPvol = recruited volume to PEEP-related volume ratio; ICP = intracranial pressure; PtiO2 = brain tissue oxygen tension; LPR = lactate/pyruvate ratio; NPI = neurological pupil index; MFV = mean flow velocity; DFV = diastolic flow velocity; PI = pulsatility index; CVP = central venous pressure; MAP = mean arterial pressure; CPP = cerebral perfusion pressure; LVOT VTI = left ventricle outflow tract velocity-time integral; CO = cardiac output (echocardiographically estimated)
Measured: Recorded every minute during 10 minutes at the end of each 45-minute period (PEEP 5 and 15 cmH2O), 90 minutes
Correlation between Vd/Vt and the following parameters at the two PEEP levels: ICP, PtiO2, LPR, NPI, MFV, DFV, PI; CPP
Respiratory mechanics; intracranial pressure monitoring, brain tissue oxygen tension; cerebral microdyalisis analytes; automated infrared pupillometry; transcranial doppler ultrasound; invasive intravascular pressures.
Vd/Vt = dead space to tidal volume ratio; ICP = intracranial pressure; PtiO2 = brain tissue oxygen tension; LPR = lactate/pyruvate ratio; NPI = neurological pupil index; MFV = mean flow velocity; DFV = diastolic flow velocity; PI = pulsatility index; CVP = central venous pressure; CPP = cerebral perfusion pressure
Measured: Recorded every minute during 10 minutes at the end of each 45-minute period (PEEP 5 and 15 cmH2O), 90 minutes
Correlation between baseline PI at transcranial doppler ultrasound and the following parameters at the two PEEP levels: ICP, PtiO2, LPR, NPI, MFV, DFV, PI; LVOT VTI, CO, MAP, CPP.
Intracranial pressure monitoring, Brain tissue oxygen tension; cerebral microdyalisis analytes; automated infrared pupillometry; transcranial doppler ultrasound; Echocardiography; invasive intravascular pressures.
PI = pulsatility index; ICP = intracranial pressure; PtiO2 = brain tissue oxygen tension; LPR = lactate/pyruvate ratio; NPI = neurological pupil index; MFV = mean flow velocity; DFV = diastolic flow velocity; PI = pulsatility index; LVOT VTI = left ventricle outflow tract velocity-time integral; CO = cardiac output (echocardiographically estimated); MAP = mean arterial pressure; CPP = cerebral perfusion pressure
Measured: Recorded every minute during 10 minutes at the end of each 45-minute period (PEEP 5 and 15 cmH2O), 90 minutes
Correlation between CVP and the following parameters at the two PEEP levels : ICP, PtiO2, LPR, NPI, MFV, DFV, PI; LVOT VTI, CO, MAP, CPP, dose of vasopressors/inotropes and volume of fluid boluses administered.
Intracranial pressure monitoring, Brain tissue oxygen tension; cerebral microdyalisis analytes; automated infrared pupillometry; transcranial doppler ultrasound; Echocardiography; invasive intravascular pressures; administered drugs and fluids.
CVP = central venous pressure; ICP = intracranial pressure; PtiO2 = brain tissue oxygen tension; LPR = lactate/pyruvate ratio; NPI = neurological pupil index; MFV = mean flow velocity; DFV = diastolic flow velocity; PI = pulsatility index; LVOT VTI = left ventricle outflow tract velocity-time integral; CO = cardiac output (echocardiographically estimated); MAP = mean arterial pressure; CPP = cerebral perfusion pressure
Measured: Recorded every minute during 10 minutes at the end of each 45-minute period (PEEP 5 and 15 cmH2O), 90 minutes
Correlation between LVOT VTI and the following parameters at the two PEEP levels: PtiO2, LPR, NPI, MFV, DFV, PI; MAP, CPP, dose of vasopressors/inotropes and volume of fluid boluses administered.
Brain tissue oxygen tension; cerebral microdyalisis analytes; automated infrared pupillometry; transcranial doppler ultrasound; echocardiography, invasive intravascular pressures; administered drugs and fluids.
LVOT VTI = left ventricle outflow tract velocity-time integral; PtiO2 = brain tissue oxygen tension; LPR = lactate/pyruvate ratio; NPI = neurological pupil index; MFV = mean flow velocity; DFV = diastolic flow velocity; PI = pulsatility index; MAP = mean arterial pressure; CPP = cerebral perfusion pressure
Measured: Recorded every minute during 10 minutes at the end of each 45-minute period (PEEP 5 and 15 cmH2O), 90 minutes
Correlation between PtiO2 and the following parameters at the two PEEP levels: ICP, MAP, dose of vasopressors/inotropes and volume of fluid boluses administered.
Intracranial pressure monitoring, brain tissue oxygen tension; invasive intravascular pressures; administered drugs and fluids.
PtiO2 = brain tissue oxygen tension; ICP = intracranial pressure; MAP = mean arterial pressure
Measured: Recorded every minute during 10 minutes at the end of each 45-minute period (PEEP 5 and 15 cmH2O), 90 minutes
Correlation between LPR and the following parameters at the two PEEP levels: ICP, MAP, dose of vasopressors/inotropes and volume of fluid boluses administered.
Intracranial pressure monitoring, cerebral microdyalisis analytes; invasive intravascular pressures; administered drugs and fluids.
LPR = lactate/pyruvate ratio; ICP = intracranial pressure; MAP = mean arterial pressure
Measured: Recorded every minute during 10 minutes at the end of each 45-minute period (PEEP 5 and 15 cmH2O), 90 minutes
Correlation between NPI and the following parameters at the two PEEP levels: ICP, MAP, dose of vasopressors/inotropes and volume of fluid boluses administered.
Intracranial pressure monitoring, automated infrared pupillometry; invasive intravascular pressures; administered drugs and fluids.
NPI = neurological pupil index; ICP = intracranial pressure; MAP = mean arterial pressure
Measured: Recorded every minute during 10 minutes at the end of each 45-minute period (PEEP 5 and 15 cmH2O), 90 minutes
Correlation between doppler indices (MFV, DFV and PI) and the following parameters at the two PEEP levels: ICP, MAP, dose of vasopressors/inotropes and volume of fluid boluses administered.
Intracranial pressure monitoring, transcranial doppler ultrasound; invasive intravascular pressures; administered drugs and fluids.
MFV = mean flow velocity; DFV = diastolic flow velocity; PI = pulsatility index; ICP = intracranial pressure; MAP = mean arterial pressure
Measured: Recorded every minute during 10 minutes at the end of each 45-minute period (PEEP 5 and 15 cmH2O), 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start1 Aug 2019
- Primary completion2 Nov 2020
- Study completion2 Nov 2020
Why it stopped: Due to the COVID epidemics, starting with patient recruitement was not possible.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Patients included will receive volume assist-control ventilation with PEEP set at 5 cmH2O and 15 cmH2O in a randomized order (crossover design). Each setting will be applied during 45 minutes.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Piquilloud Imboden Lise
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Piquilloud Imboden Lise, University of Lausanne Hospitals
- Investigators
- Lise Piquilloud, MER&PD, Principal investigator, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04013698
- Sponsor's protocol ID
- ABIVENT
- Acronym
- ABIVENT
- Status last verified
- Nov 2020
- First submitted
- 1 Jul 2019
- Last updated
- 11 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Chest Wall and Lung Elastances on Intracranial Pressure and Brain-specific Multimodal Monitoring in Ventilated Brain Injured Patients
- ClinicalTrials.gov ID
- NCT04013698
- Acronym / sponsor ID
- ABIVENT / ABIVENT
- Conditions
- Brain Injuries
- Keywords
- ventilation, brain injuries, PEEP, esophageal pressure
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to the COVID epidemics, starting with patient recruitement was not possible.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Piquilloud Imboden LiseUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 2 Nov 2020 (actual)
- Study completion
- 2 Nov 2020 (actual)
- First posted
- 10 Jul 2019 (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.
Increase in intracranial pressure (ICP) could be associated with increase in positive end-expiratory pressure (PEEP) level. Data are however disparate and interactions between ventilation with high PEEP and intracranial circulation are still debated. Individual patient's chest wall elastance could have a key role in determining the effects of PEEP on ICP, since it dictates which proportion of the applied PEEP is transmitted to the pleural space, thus increasing central venous pressure (CVP) and reducing cerebral venous return. Measurement of esophageal pressure with a dedicated probe allows partitioning of respiratory system elastance into its lung and chest wall components, thus permitting to study this phenomenon. Multimodal intracranial monitoring permits to study the effects of PEEP on more advanced brain-specific indices such as brain tissue oxygen (PtiO2), cerebral microdialysis data, transcranial doppler ultrasound-derived flow measurements and automated pupillometry, besides ICP.
This study aims to test the association between the ratio of chest wall to respiratory system elastance and PEEP-induced variations in ICP and brain-specific multimodal monitoring indices. This study will evaluate the relative role of other selected measures of respiratory mechanics, hemodynamic variables and intracranial compliance, in order to establish the role of individual respiratory mechanics in the interplay of physiological factors affecting the effects of positive pressure ventilation on the brain.
Patients will undergo two periods of ventilation at two different levels of PEEP (5 and 15 cmH2O) in a randomized cross-over order. At the end of each period, cardiorespiratory clinical data, ICP and other advanced multimodal neuromonitoring data (brain tissue oxygen tension, cerebral microdyalisis analytes, transcranial doppler ultrasound and automated infrared pupillometry data) will be collected. Systematic respiratory mechanics assessment (including calculation of chest wall and lung elastances and estimation of the amount of recruitment versus overdistension due to PEEP by means of a single-breath derecruitment trial), echocardiography and arterial blood gas analysis will be performed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients included will receive volume assist-control ventilation with PEEP set at 5 cmH2O and 15 cmH2O in a randomized order (crossover design). Each setting will be applied during 45 minutes.
| Arm | Type | Receives |
|---|---|---|
| PEEP level 5 cmH2O to 15 cmH2O | Experimental | Other: PEEP level 5 cmH2O, Other: PEEP level 15 cmH2O |
| PEEP level 15 cmH2O to 5 cmH2O | Experimental | Other: PEEP level 5 cmH2O, Other: PEEP level 15 cmH2O |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Acute brain injury of any etiology requiring multimodal brain monitoring (intraparenchymal intracranial pressure, brain-tissue oxygen tension and cerebral microdialysis)
- Controlled mechanical ventilation via endotracheal tube
- Patient needing deep sedation
Key exclusion criteria (7 listed)
- pregnancy
- contraindications to nasogastric probe placement: basilar skull or significant naso-facial fractures, significant esophageal or gastric trauma or bleeding, previous esophageal surgery, significant bleeding diathesis (spontaneous aPTT > 60 sec, PT < 40%, INR > 1.8, platelets < 50000/mm3), known esophageal or gastric varices
- decompressive craniectomy
- intracranial pressure monitoring method other than intraparenchymal (e.g. connected to external ventricular drain)
- severe relevant physiological instability contraindicating an increase in PEEP: severe baseline intracranial pressure elevation (> 20 mmHg), severe hemodynamic instability (defined as norepinephrine requirements > 0.5 μg/kg/min or cardiogenic shock, defined as any use of dobutamine)
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 |
|---|---|---|
| PEEP level 5 cmH2OPEEP level set for 45 minutes | Other | PEEP level 15 cmH2O to 5 cmH2O, PEEP level 5 cmH2O to 15 cmH2O |
| PEEP level 15 cmH2OPEEP level set for 45 minutes | Other | PEEP level 15 cmH2O to 5 cmH2O, PEEP level 5 cmH2O to 15 cmH2O |
Primary outcome
Correlation between Ers/Ecw and change in ICP between the two PEEP levels
Time frame: Recorded every minute during 10 minutes at the end of each 45-minute period (PEEP 5 and 15 cmH2O), 90 minutes
Respiratory mechanics; intracranial pressure monitoring Ers/Ecw = chest wall to respiratory system elastances ratio; ICP = intracranial pressure
19 secondary outcomes
Correlation between Ecw/Ers and the following neuromonitoring indices at the two PEEP levels: PtiO2, LPR, NPI; MFV, DFV and PI.
Time frame: Recorded every minute during 10 minutes at the end of each 45-minute period (PEEP 5 and 15 cmH2O), 90 minutes
Effect of the two different levels of PEEP on NPI.
Time frame: Recorded every minute during 10 minutes at the end of each 45-minute period (PEEP 5 and 15 cmH2O), 90 minutes
Effect of the two different levels of PEEP on the following transcranial doppler ultrasound variables: MFV, DFV and PI.
Time frame: Recorded every minute during 10 minutes at the end of each 45-minute period (PEEP 5 and 15 cmH2O), 90 minutes
Effect of the two different levels of PEEP on LPR.
Time frame: Recorded every minute during 10 minutes at the end of each 45-minute period (PEEP 5 and 15 cmH2O), 90 minutes
Effect of the two different levels of PEEP on PtiO2.
Time frame: Recorded every minute during 10 minutes at the end of each 45-minute period (PEEP 5 and 15 cmH2O), 90 minutes
Effect of the two different levels of PEEP on the following intravascular pressures: CVP, MAP, CPP.
Time frame: Recorded every minute during 10 minutes at the end of each 45-minute period (PEEP 5 and 15 cmH2O), 90 minutes
Effect of the two different levels of PEEP on the following echocardiographic measurements: LVOT VTI, CO.
Time frame: Recorded every minute during 10 minutes at the end of each 45-minute period (PEEP 5 and 15 cmH2O), 90 minutes
Effect of the two different levels of PEEP on the dose of vasopressors/inotropes and volume of fluid boluses administered.
Time frame: Recorded every minute during 10 minutes at the end of each 45-minute period (PEEP 5 and 15 cmH2O), 90 minutes
Correlation between Ers/Ecw and the following parameters at the two PEEP levels: LVOT VTI, CO; CVP, MAP, CPP; dose of vasopressors/inotropes and volume of fluid boluses administered.
Time frame: Recorded every minute during 10 minutes at the end of each 45-minute period (PEEP 5 and 15 cmH2O), 90 minutes
Correlation between Pes_end-exp and the following parameters at the two PEEP levels: ICP, PtiO2, LPR, NPI, MFV, DFV, PI; CVP, MAP, CPP, LVOT VTI, CO, dose of vasopressors/inotropes and volume of fluid boluses administered.
Time frame: Recorded every minute during 10 minutes at the end of each 45-minute period (PEEP 5 and 15 cmH2O), 90 minutes
Correlation between Rec/PEEPvol and the following parameters at the two PEEP levels: ICP, PtiO2, LPR, NPI, MFV, DFV, PI; CVP, MAP, CPP, LVOT VTI, CO, dose of vasopressors/inotropes and volume of fluid boluses administered.
Time frame: Recorded every minute during 10 minutes at the end of each 45-minute period (PEEP 5 and 15 cmH2O), 90 minutes
Correlation between Vd/Vt and the following parameters at the two PEEP levels: ICP, PtiO2, LPR, NPI, MFV, DFV, PI; CPP
Time frame: Recorded every minute during 10 minutes at the end of each 45-minute period (PEEP 5 and 15 cmH2O), 90 minutes
Correlation between baseline PI at transcranial doppler ultrasound and the following parameters at the two PEEP levels: ICP, PtiO2, LPR, NPI, MFV, DFV, PI; LVOT VTI, CO, MAP, CPP.
Time frame: Recorded every minute during 10 minutes at the end of each 45-minute period (PEEP 5 and 15 cmH2O), 90 minutes
Correlation between CVP and the following parameters at the two PEEP levels : ICP, PtiO2, LPR, NPI, MFV, DFV, PI; LVOT VTI, CO, MAP, CPP, dose of vasopressors/inotropes and volume of fluid boluses administered.
Time frame: Recorded every minute during 10 minutes at the end of each 45-minute period (PEEP 5 and 15 cmH2O), 90 minutes
Correlation between LVOT VTI and the following parameters at the two PEEP levels: PtiO2, LPR, NPI, MFV, DFV, PI; MAP, CPP, dose of vasopressors/inotropes and volume of fluid boluses administered.
Time frame: Recorded every minute during 10 minutes at the end of each 45-minute period (PEEP 5 and 15 cmH2O), 90 minutes
Correlation between PtiO2 and the following parameters at the two PEEP levels: ICP, MAP, dose of vasopressors/inotropes and volume of fluid boluses administered.
Time frame: Recorded every minute during 10 minutes at the end of each 45-minute period (PEEP 5 and 15 cmH2O), 90 minutes
Correlation between LPR and the following parameters at the two PEEP levels: ICP, MAP, dose of vasopressors/inotropes and volume of fluid boluses administered.
Time frame: Recorded every minute during 10 minutes at the end of each 45-minute period (PEEP 5 and 15 cmH2O), 90 minutes
Correlation between NPI and the following parameters at the two PEEP levels: ICP, MAP, dose of vasopressors/inotropes and volume of fluid boluses administered.
Time frame: Recorded every minute during 10 minutes at the end of each 45-minute period (PEEP 5 and 15 cmH2O), 90 minutes
Correlation between doppler indices (MFV, DFV and PI) and the following parameters at the two PEEP levels: ICP, MAP, dose of vasopressors/inotropes and volume of fluid boluses administered.
Time frame: Recorded every minute during 10 minutes at the end of each 45-minute period (PEEP 5 and 15 cmH2O), 90 minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
- Individual participant dataSharing planned: Undecided
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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.
Lise Piquilloud, MER&PD principal investigator
University of Lausanne Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEEP level 5 cmH2O and PEEP level 15 cmH2O in people with Brain Injuries, run by Piquilloud Imboden Lise at 1 site in Switzerland.
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 3 inclusion and 7 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: withdrawn, as of the sponsor's last update on 11 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between Ers/Ecw and change in ICP between the two PEEP levels (time frame: Recorded every minute during 10 minutes at the end of each 45-minute period (PEEP 5 and 15 cmH2O), 90 minutes). 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 11 Jun 2021.