Neuro: Cerebrovascular AccidentNAVAPSVHEADNCT03721354
Comparison Between NAVA and PSV in Neurocritical Patients
A study testing NAVA vs PSV - TCCD in people with Neuro: Cerebrovascular Accident and Trauma, Head, run by Azienda Ospedaliero Universitaria Maggiore della Carita at 1 site in Italy.
Trial summary
Partial assisted mechanical ventilation modes are widely used to manage respiratory failure. It has been demonstrated that they can reduce complications related to mechanical ventilation and neuromuscular blocking agents administration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuro: Cerebrovascular Accident, Trauma, Head
- What is being tested?
- NAVA vs PSV - TCCD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2018to 31 Dec 2019
- 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
- Every ICU patient sedated and intubated, admitted for intracranial disease (neuromuscular disease and head trauma);
- intracranial pressure monitoring
- Mechanical ventilation for more than 48 hours
- Readiness for assisted mechanical ventilation at the screening
Who cannot join
- intracranial pressure instability more than 15 cmH2O;
- symptomatic vasospasm;
- average cerebral flow velocity at transcranial basal doppler in M1 more than 120 cm/sec
- hemodynamic instability;
- gastro-esophageal surgery in the previous 12 months;
- gastro-esophageal bleeding in the previous 30 days;
Show all 12Show fewer
- history of esophageal varices;
- maxillofacial trauma or surgery;
- body temperature more than 38° C at the time of the study;
- coagulation disorders;
- PaCO2 not included in the basal range (between 35 and 45 mmHg) or paCo2 variation more than +/- 20% obtained in partially assisted mode compared to baseline;
- pregnancy;
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
A.O.U Maggiore della Carità
Novara, 28100
Gianmaria Cammarota, MD,PhD, 003903213733406, gmcamma@gmail.com
About this study
Official title: Comparison Between NAVA and PSV in Neurocritical Patients: a Pilot Study
Partial assisted mechanical ventilation modes are widely used to manage respiratory failure. It has been demonstrated that they can reduce complications related to mechanical ventilation and neuromuscular blocking agents administration.
During partially assisted ventilation, there is no predefined respiratory rate and the patient must trigger each breath.
Read more
One of the most used partial assisted mode is pressure support ventilation (PSV), which plays a key role in weaning from mechanical ventilation, especially in neuro-cranial diseases.
Neurally adjusted ventilatory assist mode (NAVA) has been introduced in clinical practice in recent years. It has been widely demonstrated that NAVA is able to guarantee gas exchange in the same way as PSV in patients admitted to ICU for respiratory failure.
Thus, NAVA can improve patient-ventilator interaction reducing the incidence of asynchronous events and favoring the patient's own ventilatory pattern. Nevertheless, NAVA does not appear to have been applied in neuro ICU patients. In a study conducted on non-neurosurgical infants has been demonstrated negative effects of asynchronous events on cerebral blood flow velocities, examined with transcranial Doppler technique.
In the present pilot study, the investigators would like to compare NAVA and PSV ventilation influence on cranial blood flow, evaluated with Trans-Cranial Color Doppler, in patients admitted to ICU for neurological injuries.
Read the detailed description
The aim of this pilot study is to compare NAVA and PSV in order to establish their influence on cranial blood flow, assessed in the mean cerebral artery (M1 tract bilaterally). Secondarily, it will be evaluated the effectiveness in guaranteeing the gas exchange and patient-ventilator interaction during each ventilation mode.
Patients will be evaluated in order to establish their readiness for assisted mechanical ventilation.
The following clinical criteria must be respected:
- a heart rate of less than 120 bpm, blood pressure between 90 and 180 mmHg;
- dopamine/dobutamine less than 5 mcg/kg/minute, norepinephrine less than 0.25 mcg/kg/min;
- PaO2/FiO2 > 150;
- PEEP (positive end-expiratory pressure) minor or equal to 10 cmH2O;
- Vt between 6 and 8 ml/kg;
- respiratory rate less than 35 breaths per minutes and without respiratory distress signs;
- blood pH between 7.35 and 7.45; Afterward, patients will be submitted to three different mechanical ventilation trials in partially assisted modes: the first one in PSV mode, the second one in NAVA mode and the third one in PSV mode again. Each trial will last 30 minutes. PSV will have PEEP set by clinician and pressure support will be set in order to obtain Vt between 6 and 8 ml/kg. NAVA will have the same PEEP as PSV and NAVA level will be set to obtain the same peak of Inspiratory pressure of PSV.
The expiratory trigger will be adjusted to the 50% of the inspiratory flow peak in PSV. During NAVA, the expiratory trigger is fixed to 75% of diaphragmatic electrical activity. The inspiratory fraction of oxygen (FiO2) will be set in order to obtain a peripheral oxygen saturation of more than 94%.
Ultrasound evaluation, using transcranial Doppler technique will be performed to evaluate the cerebral blood flow speed (average/systolic speed) near the point of emergency, in the middle length and at the bifurcation of M1 bilaterally, at the end of every ventilation trial. At the end of each trial, PaCO2, Ph and blood oxygenation (PaO2) will be obtained performing ABGs. Moreover, traces of flow, airways pressure (Paw) and electric diaphragmatic activity (EAdi) will be recorded and acquired through a dedicated ventilator software called NAVA tracker.
This will allow evaluating the patient-ventilator interaction (trigger delay, asynchronous events, and asynchrony index).
- Conditions
- Neuro: Cerebrovascular Accident, Trauma, Head
- Being tested
- NAVA vs PSV - TCCD
- Medical subject headings
- Craniocerebral Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NAVA vs PSV - TCCDOther
Patients will be submitted to 3 different 30 minutes ventilation trials: the first one in PSV mode, the second one in NAVA mode and the third one in PSV mode again. PSV will have PEEP setted by clinician and pressure support set in order to obtain Vt 6-8 ml/kg. NAVA will have the same PEEP as PSV and NAVA level will be set to obtain the same Peak of Inspiratory Pressure) of PSV.
Trans cranial doppler technique will be performed to evaluate the blood cerebral flow speed (average/systolic speed) at the end of every ventilation trial. At the end of each trial, ABGs will be performed. Traces of flow, airways pressure (Paw) and electric diaphragmatic activity (EAdi) will be recorded and acquired through a dedicated ventilator software called NAVA tracker.
| Study group | Role | What they receive |
|---|---|---|
| NAVA vs PSV -TCCD | Experimental | Ultrasound evaluation, using trans cranial doppler technique will be performed to evaluate the cerebral blood flow speed (average/systolic speed) near the point of emergency, in the middle tract and at the bifurcation of M1 bilaterally, at the end of every ventilation trial (NAVA and PSV). Receives: Other: NAVA vs PSV - TCCD |
What is being measured
The primary outcome is the main question the study is designed to answer.
NAVA safety- Change in cranial blood flow velocity
Ultrasound evaluation, using trans cranial doppler technique will be performed to evaluate the blood cerebral flow speed (average/systolic speed) near the point of emergency, in the middle tract and at the bifurcation of M1 bilaterally.
Measured: After ventilatory modes is applied, a time range of 20 minutes will be considered necessary to assess cerebral blood flow. This evaluation will be performed over time range of 5-15 seconds (in any case the time of 3 doppler signal beats)
Secondary outcomes (6)
Gas exchange - arterial carbon dioxide tension
PaCO2, will be obtained performing ABG sample
Measured: After ventilatory modes is applied, a time range of 20 minutes will be considered necessary to assess arterial blood gas analysis. this evaluation will be run at the end of each trial for a total of 3 sample in 60 minutes.
Gas exchange - pH
pH will be obtained performing ABGs.
Measured: After ventilatory modes is applied, a time range of 20 minutes will be considered necessary to assess arterial blood gas analysis. this evaluation will be run at the end of each trial for a total of
Gas exchange - arterial oxygen tension
arterial oxygenation PaO2 will be obtained performing ABGs.
Measured: After ventilatory modes is applied, a time range of 20 minutes will be considered necessary to assess arterial blood gas analysis. this evaluation will be run at the end of each trial for a total of 3 sample in 60 minutes.
Patient-ventilator interaction 1
trigger delay (msec)
Measured: After ventilatory modes is applied, a time range of 20 minutes will be considered necessary to assess arterial blood gas analysis. this evaluation will be run at the end of each trial for a total of 3 times per hour.
Patient-ventilator interaction 2
synchronous events (total number of asynchrony events) and asynchrony index.
Measured: After ventilatory modes is applied, a time range of 20 minutes will be considered necessary to assess arterial blood gas analysis. this evaluation will be run at the end of each trial for a total of 3 times per hour.
Patient-ventilator interaction 3
asynchrony index (total number of asynchrony events on respiratory rate *100)
Measured: After ventilatory modes is applied, a time range of 20 minutes will be considered necessary to assess arterial blood gas analysis. this evaluation will be run at the end of each trial for a total of 3 times per hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2018
- Study start1 Nov 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Neuro: Cerebrovascular AccidentStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- pilot interventional study
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della Carita
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianmaria Cammarota, Azienda Ospedaliero Universitaria Maggiore della Carita
- Investigators
- Gianmaria Cammarota, MD,PHD, Principal investigator, "Maggiore della Carità" Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03721354
- Sponsor's protocol ID
- CE 114/18
- Acronym
- NAVAPSVHEAD
- Status last verified
- Jul 2019
- First submitted
- 18 Oct 2018
- Last updated
- 19 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Levine S, Nguyen T, Taylor N, Friscia ME, Budak MT, Rothenberg P, Zhu J, Sachdeva R, Sonnad S, Kaiser LR, Rubinstein NA, Powers SK, Shrager JB. Rapid disuse atrophy of diaphragm fibers in mechanically ventilated humans. N Engl J Med. 2008 Mar 27;358(13):1327-35. doi: 10.1056/NEJMoa070447.
PubMed 18367735Dekel B, Segal E, Perel A. Pressure support ventilation. Arch Intern Med. 1996 Feb 26;156(4):369-73.
PubMed 8607722Cormio M, Portella G, Spreafico E, Mazza L, Pesenti A, Citerio G. [Role of assisted breathing in severe traumatic brain injury]. Minerva Anestesiol. 2002 Apr;68(4):278-84. Italian.
PubMed 12024100Navalesi P, Longhini F. Neurally adjusted ventilatory assist. Curr Opin Crit Care. 2015 Feb;21(1):58-64. doi: 10.1097/MCC.0000000000000167.
PubMed 25486574Colombo D, Cammarota G, Bergamaschi V, De Lucia M, Corte FD, Navalesi P. Physiologic response to varying levels of pressure support and neurally adjusted ventilatory assist in patients with acute respiratory failure. Intensive Care Med. 2008 Nov;34(11):2010-8. doi: 10.1007/s00134-008-1208-3. Epub 2008 Jul 16.
PubMed 18629471Rennie JM, South M, Morley CJ. Cerebral blood flow velocity variability in infants receiving assisted ventilation. Arch Dis Child. 1987 Dec;62(12):1247-51. doi: 10.1136/adc.62.12.1247.
PubMed 3324972Aaslid R. Transcranial Doppler assessment of cerebral vasospasm. Eur J Ultrasound. 2002 Nov;16(1-2):3-10. doi: 10.1016/s0929-8266(02)00045-9.
PubMed 12470845Cammarota G, Verdina F, Lauro G, Boniolo E, Tarquini R, Messina A, De Vita N, Sguazzoti I, Perucca R, Corte FD, Vignazia GL, Grossi F, Crudo S, Navalesi P, Santangelo E, Vaschetto R. Neurally adjusted ventilatory assist preserves cerebral blood flow velocity in patients recovering from acute brain injury. J Clin Monit Comput. 2021 May;35(3):627-636. doi: 10.1007/s10877-020-00523-w. Epub 2020 May 9.
PubMed 32388653
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between NAVA and PSV in Neurocritical Patients: a Pilot Study
- ClinicalTrials.gov ID
- NCT03721354
- Acronym / sponsor ID
- NAVAPSVHEAD / CE 114/18
- Conditions
- Neuro: Cerebrovascular Accident, Trauma, Head
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della CaritaUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 26 Oct 2018 (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.
Partial assisted mechanical ventilation modes are widely used to manage respiratory failure. It has been demonstrated that they can reduce complications related to mechanical ventilation and neuromuscular blocking agents administration.
During partially assisted ventilation, there is no predefined respiratory rate and the patient must trigger each breath.
One of the most used partial assisted mode is pressure support ventilation (PSV), which plays a key role in weaning from mechanical ventilation, especially in neuro-cranial diseases.
Neurally adjusted ventilatory assist mode (NAVA) has been introduced in clinical practice in recent years. It has been widely demonstrated that NAVA is able to guarantee gas exchange in the same way as PSV in patients admitted to ICU for respiratory failure.
Thus, NAVA can improve patient-ventilator interaction reducing the incidence of asynchronous events and favoring the patient's own ventilatory pattern. Nevertheless, NAVA does not appear to have been applied in neuro ICU patients. In a study conducted on non-neurosurgical infants has been demonstrated negative effects of asynchronous events on cerebral blood flow velocities, examined with transcranial Doppler technique.
In the present pilot study, the investigators would like to compare NAVA and PSV ventilation influence on cranial blood flow, evaluated with Trans-Cranial Color Doppler, in patients admitted to ICU for neurological injuries.
Detailed description
The aim of this pilot study is to compare NAVA and PSV in order to establish their influence on cranial blood flow, assessed in the mean cerebral artery (M1 tract bilaterally). Secondarily, it will be evaluated the effectiveness in guaranteeing the gas exchange and patient-ventilator interaction during each ventilation mode.
Patients will be evaluated in order to establish their readiness for assisted mechanical ventilation.
The following clinical criteria must be respected:
- a heart rate of less than 120 bpm, blood pressure between 90 and 180 mmHg;
- dopamine/dobutamine less than 5 mcg/kg/minute, norepinephrine less than 0.25 mcg/kg/min;
- PaO2/FiO2 > 150;
- PEEP (positive end-expiratory pressure) minor or equal to 10 cmH2O;
- Vt between 6 and 8 ml/kg;
- respiratory rate less than 35 breaths per minutes and without respiratory distress signs;
- blood pH between 7.35 and 7.45; Afterward, patients will be submitted to three different mechanical ventilation trials in partially assisted modes: the first one in PSV mode, the second one in NAVA mode and the third one in PSV mode again. Each trial will last 30 minutes. PSV will have PEEP set by clinician and pressure support will be set in order to obtain Vt between 6 and 8 ml/kg. NAVA will have the same PEEP as PSV and NAVA level will be set to obtain the same peak of Inspiratory pressure of PSV.
The expiratory trigger will be adjusted to the 50% of the inspiratory flow peak in PSV. During NAVA, the expiratory trigger is fixed to 75% of diaphragmatic electrical activity. The inspiratory fraction of oxygen (FiO2) will be set in order to obtain a peripheral oxygen saturation of more than 94%.
Ultrasound evaluation, using transcranial Doppler technique will be performed to evaluate the cerebral blood flow speed (average/systolic speed) near the point of emergency, in the middle length and at the bifurcation of M1 bilaterally, at the end of every ventilation trial. At the end of each trial, PaCO2, Ph and blood oxygenation (PaO2) will be obtained performing ABGs. Moreover, traces of flow, airways pressure (Paw) and electric diaphragmatic activity (EAdi) will be recorded and acquired through a dedicated ventilator software called NAVA tracker.
This will allow evaluating the patient-ventilator interaction (trigger delay, asynchronous events, and asynchrony index).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- pilot interventional study
| Arm | Type | Receives |
|---|---|---|
| NAVA vs PSV -TCCD | Experimental | Other: NAVA vs PSV - TCCDUltrasound evaluation, using trans cranial doppler technique will be performed to evaluate the cerebral blood flow speed (average/systolic speed) near the point of emergency, in the middle tract and at the bifurcation of M1 bilaterally, at the end of every ventilation trial (NAVA and PSV). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Every ICU patient sedated and intubated, admitted for intracranial disease (neuromuscular disease and head trauma);
- intracranial pressure monitoring
- Mechanical ventilation for more than 48 hours
- Readiness for assisted mechanical ventilation at the screening
Key exclusion criteria (12 listed)
- intracranial pressure instability more than 15 cmH2O;
- symptomatic vasospasm;
- average cerebral flow velocity at transcranial basal doppler in M1 more than 120 cm/sec
- hemodynamic instability;
- gastro-esophageal surgery in the previous 12 months;
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 |
|---|---|---|
| NAVA vs PSV - TCCDPatients will be submitted to 3 different 30 minutes ventilation trials: the first one in PSV mode, the second one in NAVA mode and the third one in PSV mode again. PSV will have PEEP setted by clinician and pressure support set in order to obtain Vt 6-8 ml/kg. NAVA will have the same PEEP as PSV and NAVA level will be set to obtain the same Peak of Inspiratory Pressure) of PSV. Trans cranial doppler technique will be performed to evaluate the blood cerebral flow speed (average/systolic speed) at the end of every ventilation trial. At the end of each trial, ABGs will be performed. Traces of flow, airways pressure (Paw) and electric diaphragmatic activity (EAdi) will be recorded and acquired through a dedicated ventilator software called NAVA tracker. | Other | NAVA vs PSV -TCCD |
Primary outcome
NAVA safety- Change in cranial blood flow velocity
Time frame: After ventilatory modes is applied, a time range of 20 minutes will be considered necessary to assess cerebral blood flow. This evaluation will be performed over time range of 5-15 seconds (in any case the time of 3 doppler signal beats)
Ultrasound evaluation, using trans cranial doppler technique will be performed to evaluate the blood cerebral flow speed (average/systolic speed) near the point of emergency, in the middle tract and at the bifurcation of M1 bilaterally.
6 secondary outcomes
Gas exchange - arterial carbon dioxide tension
Time frame: After ventilatory modes is applied, a time range of 20 minutes will be considered necessary to assess arterial blood gas analysis. this evaluation will be run at the end of each trial for a total of 3 sample in 60 minutes.
Gas exchange - pH
Time frame: After ventilatory modes is applied, a time range of 20 minutes will be considered necessary to assess arterial blood gas analysis. this evaluation will be run at the end of each trial for a total of
Gas exchange - arterial oxygen tension
Time frame: After ventilatory modes is applied, a time range of 20 minutes will be considered necessary to assess arterial blood gas analysis. this evaluation will be run at the end of each trial for a total of 3 sample in 60 minutes.
Patient-ventilator interaction 1
Time frame: After ventilatory modes is applied, a time range of 20 minutes will be considered necessary to assess arterial blood gas analysis. this evaluation will be run at the end of each trial for a total of 3 times per hour.
Patient-ventilator interaction 2
Time frame: After ventilatory modes is applied, a time range of 20 minutes will be considered necessary to assess arterial blood gas analysis. this evaluation will be run at the end of each trial for a total of 3 times per hour.
Patient-ventilator interaction 3
Time frame: After ventilatory modes is applied, a time range of 20 minutes will be considered necessary to assess arterial blood gas analysis. this evaluation will be run at the end of each trial for a total of 3 times per hour.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
- Background: PubMed 18367735Levine S, Nguyen T, Taylor N, Friscia ME, Budak MT, Rothenberg P, Zhu J, Sachdeva R, Sonnad S, Kaiser LR, Rubinstein NA, Powers SK, Shrager JB. Rapid disuse atrophy of diaphragm fibers in mechanically ventilated humans. N Engl J Med. 2008 Mar 27;358(13):1327-35. doi: 10.1056/NEJMoa070447.
- Background: PubMed 8607722Dekel B, Segal E, Perel A. Pressure support ventilation. Arch Intern Med. 1996 Feb 26;156(4):369-73.
- Background: PubMed 12024100Cormio M, Portella G, Spreafico E, Mazza L, Pesenti A, Citerio G. [Role of assisted breathing in severe traumatic brain injury]. Minerva Anestesiol. 2002 Apr;68(4):278-84. Italian.
- Background: PubMed 25486574Navalesi P, Longhini F. Neurally adjusted ventilatory assist. Curr Opin Crit Care. 2015 Feb;21(1):58-64. doi: 10.1097/MCC.0000000000000167.
- Background: PubMed 18629471Colombo D, Cammarota G, Bergamaschi V, De Lucia M, Corte FD, Navalesi P. Physiologic response to varying levels of pressure support and neurally adjusted ventilatory assist in patients with acute respiratory failure. Intensive Care Med. 2008 Nov;34(11):2010-8. doi: 10.1007/s00134-008-1208-3. Epub 2008 Jul 16.
- Background: PubMed 3324972Rennie JM, South M, Morley CJ. Cerebral blood flow velocity variability in infants receiving assisted ventilation. Arch Dis Child. 1987 Dec;62(12):1247-51. doi: 10.1136/adc.62.12.1247.
- Background: PubMed 12470845Aaslid R. Transcranial Doppler assessment of cerebral vasospasm. Eur J Ultrasound. 2002 Nov;16(1-2):3-10. doi: 10.1016/s0929-8266(02)00045-9.
- Derived from this study: PubMed 32388653Cammarota G, Verdina F, Lauro G, Boniolo E, Tarquini R, Messina A, De Vita N, Sguazzoti I, Perucca R, Corte FD, Vignazia GL, Grossi F, Crudo S, Navalesi P, Santangelo E, Vaschetto R. Neurally adjusted ventilatory assist preserves cerebral blood flow velocity in patients recovering from acute brain injury. J Clin Monit Comput. 2021 May;35(3):627-636. doi: 10.1007/s10877-020-00523-w. Epub 2020 May 9.
- 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.
Gianmaria Cammarota, MD,PHD principal investigator
"Maggiore della Carità" Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NAVA vs PSV - TCCD in people with Neuro: Cerebrovascular Accident and Trauma, Head, run by Azienda Ospedaliero Universitaria Maggiore della Carita at 1 site in Italy.
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 12 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 19 Nov 2019. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gianmaria Cammarota, MD, PhD (00393392669420, gmcamma@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NAVA safety- Change in cranial blood flow velocity (time frame: After ventilatory modes is applied, a time range of 20 minutes will be considered necessary to assess cerebral blood flow. This evaluation will be performed over time range of 5-15 seconds (in any case the time of 3 doppler signal beats)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03721354, which also lists 8 linked publications.
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 19 Nov 2019.