Intracranial HypertensionNCT03144219
A Novel Non-invasive Technique of Cerebral Compliance and Auto-regulation Assessment
An observational study of Intracranial Hypertension, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Introduction: Intracranial pressure (ICP) monitoring is essential in several medical situations, however, currently there is an invasive technique, costly, not widely available and sometimes contraindicated. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intracranial Hypertension
- What is being tested?
- Transcranial Doppler (TCD) ultrasound monitoring and Non invasive intracranial compliance monitoring
- How many people
- 133 participants
- Where
- 1 siteBrazil
- Study dates
- 1 May 2017to 31 Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Neurological patients (GCS 5 and under) of any cause, gender or age.
Who may be able to join
- Patients whose underwent ICP monitoring displaying both ICP curves and values.
Who cannot join
- Patients whose display absence of insonation window
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
University of São Paulo
São Paulo, 06630-060
Sergio Brasil, 1136287231
About this study
Introduction: Intracranial pressure (ICP) monitoring is essential in several medical situations, however, currently there is an invasive technique, costly, not widely available and sometimes contraindicated. Transcranial Doppler (TCD) pulsatility index (PI) measure can provide indirect information on the cerebrovascular resistance (CVR) augmentation, which is present concomitantly with intracranial hypertension (ICH). The hypothesis that PI measure accurately indicates cerebral compliance impairment (CCI) has been not assessed by large studies currently, and would be of value as a non invasive technique to denote earlier installing of therapeutics to prevent the effects of ICH. Likewise, a novel technique of intracranial compliance assessment by means of an external sensor has been developed, still in need of being prospectively studied.
Objective: The present study aims to assess PI accuracy indicating CCI, and dynamic cerebral auto regulation (dCAR) during internal jugular veins (IJVs) compression observed by both invasive and non-invasive techniques.
Methods: A prospective, observational controlled study, including critical neurological patients with ICP monitoring in normal range (under 20 mmHg). Initially, dCAR is monitored, then, the IJVs are compressed for 60 seconds with ultrasound guidance. We evaluate optic nerve sheath prior to intervention, and dCAR, ICP values, ICP waveforms and PI variation at different times, correlating results.
Read the detailed description
Introduction
Multimodal monitoring in neurocritical care is essential in current practice. It aims to early Identify treats occurring in the brain of comatose patients and implement targeted therapies to avoid further complications and poorer outcomes.
Some of the methods used for monitoring require invasive procedures, such as the assessment of intracranial pressure (ICP) with intracranial catheter. However, these techniques can raise morbidity, are costly, and are not available or contraindicated1. In addition, the invasive ICP method is not perfectly accurate with cases in which, intracranial hypertension (ICH) may be present despite normal screen ICP values2.
Transcranial Doppler (TCD) is a noninvasive bedside ultrasound technique which could be implemented in the monitoring of raised ICP3-4 and in the identification of impaired intracranial compliance by the compression of the internal jugular veins (IJVs)1. However, such application of the method has not been validate with large prospective studies. Validation of this technique would be of value for screening patients prior to suffer the consequences of ICH.
Recently, a non-invasive cranial strain gauge sensor has been developed, able to provide the curves of cardiac beat by beat cranial dilation. The sensor registers have been demonstrated to be similar to those obtained by the invasive ICP catheters, although large series comparing both techniques are lacking.
Objectives
- Evaluate the reliability of TCD during the IJVs compression in the assessment of intracranial compliance; 2) evaluate dynamic cerebral auto regulation (dCAR) during IJVs compression. 3) Evaluate the suitability of novel non-invasive intracranial compliance system.
Methods
This is a prospective observational study which will be performed at "Hospital das Clinicas" (São Paulo University School of Medicine). The sample desired is of 50 consecutive subjects, as a pilot study based in recommendations of the literature5. After ethics committee approval, neurological patients of any cause, gender or age, whose underwent ICP monitoring displaying both ICP curves and values will be included. The non-invasive system of intracranial compliance monitoring (Brain4Care Brasil, São Carlos, Brazil) will be used concomitantly. We will exclude patients without insonation window.
The control group will be of healthy subjects, to evaluate PI and cerebral auto-regulation during IJVs compression.
Initially, the study of dynamic cerebral auto regulation through the relationship of spontaneous fluctuations of cerebral blood flow velocity in the middle cerebral arteries (MCAs) and arterial blood pressure, will be done using TCD (DWL Doppler Box 2 MHz, Germany) for five minutes, plus the optic nerve sheath measure (Sonosite Micromaxx 13 MHz, USA), then, ultrasound guided (Sonosite Micromaxx 13 MHz, USA) IJVs compression will be performed for 60 seconds in the included patients, and the following variables will be registered prior and after intervention: blood pressure, mean arterial blood pressure, heart rate, breathing rate, hemoglobin, hematocrit, carbon dioxide pressure (pCO2), oxygen saturation, systolic flow velocity, diastolic flow velocity, mean velocity, pulsatility index, ICP values and changes in the ICP relation P1-P2 (waveform behavior).
One researcher (SB) will perform TCD examinations and obtain patients data, while two blinded researchers (RN and MLO) the offline analysis.
Data will be presented as mean ± standard error of the mean or median and interquartile ranges depending on the nature of the variable. The Chi-square test (χ2) will be used to assess the difference in sex distribution and etiology between groups. To evaluate the homogeneity of the sample we will use the Lèvene test. And, we will use the Kolmogorov-Smirnov test to evaluate the normality of distribution of each variable studied. According to the homogeneity and normality of distribution (Gaussian) of the studied variable will be used the appropriate statistical test (parametric or non-parametric) for each variable. In the homogeneous and Gaussian variables during rest, the analysis of variance (ANOVA) of a factor will be used to test the differences between the groups. In cases of significant F, the Scheffé post-hoc test will be performed for multiple comparisons. In non-homogeneous and / or non-Gaussian variables during rest, the Kruskal-Wallis test will be used, followed by the Dunn's test between the groups. On the other hand, in the homogeneous and Gaussian variables analyzed during the physiological maneuvers, the analysis of variance (ANOVA) of two factors will be used to test the differences between groups. In cases of significant F, the Scheffé post-hoc test will be performed for multiple comparisons. However, in non-homogeneous and / or non-Gaussian variables analyzed during physiological maneuvers, the Wilcoxon (paired data) and Mann-Whitney (unpaired data) tests, when appropriate, will be used. Will be considered as statistically significant to differences with P values <0.05.
- Conditions
- Intracranial Hypertension
- Being tested
- Transcranial Doppler (TCD) ultrasound monitoring, Non invasive intracranial compliance monitoring
- Keywords
- intracranial pressure, transcranial Doppler, jugular compression, cerebral compliance
- Medical subject headings
- Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Doppler (TCD) ultrasound monitoringDiagnostic test
TCD monitoring comatose patients in ICU looking for signs of impaired cerebral compliance
Non invasive intracranial compliance monitoringDiagnostic test
A sensor of cardiac beat by beat cranial dilation will be used for monitoring intracranial compliance, in non-invasive fashion.
What is being measured
The primary outcome is the main question the study is designed to answer.
Impaired cerebral compliance
Performing ICP and TCD monitoring simultaneously during jugular compression, matching waveform behavior through computer software QL Online
Measured: 10 minutes
Secondary outcomes (2)
Impaired cerebral auto-regulation
The same procedure detailed above, matching mean arterial pressure and CBFv in the computer software QL Online
Measured: 10 minutes
Non-invasive intracranial compliance monitoring
The same approaches described above, using the non-invasive Brain4Care system concomitantly.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start1 May 2017
- Primary completion15 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Intracranial HypertensionStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 133 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Braincare USA Corp
- Responsible party
- Principal investigator, Sergio Brasil, MD, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03144219
- Sponsor's protocol ID
- 66721217.0.0000.0068
- Status last verified
- Sep 2022
- First submitted
- 4 May 2017
- Last updated
- 30 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dahlqvist MB, Andres RH, Raabe A, Jakob SM, Takala J, Dunser MW. Brain herniation in a patient with apparently normal intracranial pressure: a case report. J Med Case Rep. 2010 Aug 31;4:297. doi: 10.1186/1752-1947-4-297.
PubMed 20807427Bellner J, Romner B, Reinstrup P, Kristiansson KA, Ryding E, Brandt L. Transcranial Doppler sonography pulsatility index (PI) reflects intracranial pressure (ICP). Surg Neurol. 2004 Jul;62(1):45-51; discussion 51. doi: 10.1016/j.surneu.2003.12.007.
PubMed 15226070O'Brien NF, Maa T, Reuter-Rice K. Noninvasive screening for intracranial hypertension in children with acute, severe traumatic brain injury. J Neurosurg Pediatr. 2015 Oct;16(4):420-5. doi: 10.3171/2015.3.PEDS14521. Epub 2015 Jul 3.
PubMed 26140576Hertzog MA. Considerations in determining sample size for pilot studies. Res Nurs Health. 2008 Apr;31(2):180-91. doi: 10.1002/nur.20247.
PubMed 18183564Paschoal FM Jr, Bor-Seng-Shu E, Teixeira MJ. Transcranial Doppler ultrasonography with jugular vein compression can detect impairment of intracranial compliance. Clin Neurol Neurosurg. 2013 Jul;115(7):1196-8. doi: 10.1016/j.clineuro.2012.09.028. Epub 2012 Nov 3. No abstract available.
PubMed 23128012Kasprowicz M, Kazimierska A, Hendler M, Cardim D, Czosnyka Z, Czosnyka M, Paiva W, Brasil S. Invasive and Noninvasive Intracranial Pressure Pulse Waveform in Neurocritical Care Patients with Different Cranium Integrity. Neurocrit Care. 2026 Feb;44(1):282-293. doi: 10.1007/s12028-025-02382-2. Epub 2025 Oct 1.
PubMed 41034684Brasil S, Czosnyka M, Paiva WS, Frigieri G. Exploring Cerebrospinal Compensatory Zones Using a Noninvasive Approach. Neurocrit Care. 2025 Dec;43(3):834-841. doi: 10.1007/s12028-025-02320-2. Epub 2025 Jul 14.
PubMed 40659917de Moraes FM, Brasil S, Frigieri G, Robba C, Paiva W, Silva GS. ICP wave morphology as a screening test to exclude intracranial hypertension in brain-injured patients: a non-invasive perspective. J Clin Monit Comput. 2024 Aug;38(4):773-782. doi: 10.1007/s10877-023-01120-3. Epub 2024 Feb 14.
PubMed 38355918Brasil S, Romeijn H, Haspels EK, Paiva W, Schaafsma A. Improved Transcranial Doppler Waveform Analysis for Intracranial Hypertension Assessment in Patients with Traumatic Brain Injury. Neurocrit Care. 2024 Jun;40(3):931-940. doi: 10.1007/s12028-023-01849-4. Epub 2023 Nov 6.
PubMed 37932509Frigieri G, Robba C, Machado FS, Gomes JA, Brasil S. Application of non-invasive ICP waveform analysis in acute brain injury: Intracranial Compliance Scale. Intensive Care Med Exp. 2023 Jan 27;11(1):5. doi: 10.1186/s40635-023-00492-9. No abstract available.
PubMed 36703025Brasil S, Frigieri G, Taccone FS, Robba C, Solla DJF, de Carvalho Nogueira R, Yoshikawa MH, Teixeira MJ, Malbouisson LMS, Paiva WS. Noninvasive intracranial pressure waveforms for estimation of intracranial hypertension and outcome prediction in acute brain-injured patients. J Clin Monit Comput. 2023 Jun;37(3):753-760. doi: 10.1007/s10877-022-00941-y. Epub 2022 Nov 18.
PubMed 36399214
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Non-invasive Technique of Cerebral Compliance and Auto-regulation Assessment
- ClinicalTrials.gov ID
- NCT03144219
- Acronym / sponsor ID
- 66721217.0.0000.0068
- Conditions
- Intracranial Hypertension
- Keywords
- intracranial pressure, transcranial Doppler, jugular compression, cerebral compliance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 133 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Braincare USA Corp
- Study start
- 1 May 2017 (actual)
- Primary completion
- 15 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 8 May 2017 (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.
Introduction: Intracranial pressure (ICP) monitoring is essential in several medical situations, however, currently there is an invasive technique, costly, not widely available and sometimes contraindicated. Transcranial Doppler (TCD) pulsatility index (PI) measure can provide indirect information on the cerebrovascular resistance (CVR) augmentation, which is present concomitantly with intracranial hypertension (ICH). The hypothesis that PI measure accurately indicates cerebral compliance impairment (CCI) has been not assessed by large studies currently, and would be of value as a non invasive technique to denote earlier installing of therapeutics to prevent the effects of ICH. Likewise, a novel technique of intracranial compliance assessment by means of an external sensor has been developed, still in need of being prospectively studied.
Objective: The present study aims to assess PI accuracy indicating CCI, and dynamic cerebral auto regulation (dCAR) during internal jugular veins (IJVs) compression observed by both invasive and non-invasive techniques.
Methods: A prospective, observational controlled study, including critical neurological patients with ICP monitoring in normal range (under 20 mmHg). Initially, dCAR is monitored, then, the IJVs are compressed for 60 seconds with ultrasound guidance. We evaluate optic nerve sheath prior to intervention, and dCAR, ICP values, ICP waveforms and PI variation at different times, correlating results.
Detailed description
Introduction
Multimodal monitoring in neurocritical care is essential in current practice. It aims to early Identify treats occurring in the brain of comatose patients and implement targeted therapies to avoid further complications and poorer outcomes.
Some of the methods used for monitoring require invasive procedures, such as the assessment of intracranial pressure (ICP) with intracranial catheter. However, these techniques can raise morbidity, are costly, and are not available or contraindicated1. In addition, the invasive ICP method is not perfectly accurate with cases in which, intracranial hypertension (ICH) may be present despite normal screen ICP values2.
Transcranial Doppler (TCD) is a noninvasive bedside ultrasound technique which could be implemented in the monitoring of raised ICP3-4 and in the identification of impaired intracranial compliance by the compression of the internal jugular veins (IJVs)1. However, such application of the method has not been validate with large prospective studies. Validation of this technique would be of value for screening patients prior to suffer the consequences of ICH.
Recently, a non-invasive cranial strain gauge sensor has been developed, able to provide the curves of cardiac beat by beat cranial dilation. The sensor registers have been demonstrated to be similar to those obtained by the invasive ICP catheters, although large series comparing both techniques are lacking.
Objectives
- Evaluate the reliability of TCD during the IJVs compression in the assessment of intracranial compliance; 2) evaluate dynamic cerebral auto regulation (dCAR) during IJVs compression. 3) Evaluate the suitability of novel non-invasive intracranial compliance system.
Methods
This is a prospective observational study which will be performed at "Hospital das Clinicas" (São Paulo University School of Medicine). The sample desired is of 50 consecutive subjects, as a pilot study based in recommendations of the literature5. After ethics committee approval, neurological patients of any cause, gender or age, whose underwent ICP monitoring displaying both ICP curves and values will be included. The non-invasive system of intracranial compliance monitoring (Brain4Care Brasil, São Carlos, Brazil) will be used concomitantly. We will exclude patients without insonation window.
The control group will be of healthy subjects, to evaluate PI and cerebral auto-regulation during IJVs compression.
Initially, the study of dynamic cerebral auto regulation through the relationship of spontaneous fluctuations of cerebral blood flow velocity in the middle cerebral arteries (MCAs) and arterial blood pressure, will be done using TCD (DWL Doppler Box 2 MHz, Germany) for five minutes, plus the optic nerve sheath measure (Sonosite Micromaxx 13 MHz, USA), then, ultrasound guided (Sonosite Micromaxx 13 MHz, USA) IJVs compression will be performed for 60 seconds in the included patients, and the following variables will be registered prior and after intervention: blood pressure, mean arterial blood pressure, heart rate, breathing rate, hemoglobin, hematocrit, carbon dioxide pressure (pCO2), oxygen saturation, systolic flow velocity, diastolic flow velocity, mean velocity, pulsatility index, ICP values and changes in the ICP relation P1-P2 (waveform behavior).
One researcher (SB) will perform TCD examinations and obtain patients data, while two blinded researchers (RN and MLO) the offline analysis.
Data will be presented as mean ± standard error of the mean or median and interquartile ranges depending on the nature of the variable. The Chi-square test (χ2) will be used to assess the difference in sex distribution and etiology between groups. To evaluate the homogeneity of the sample we will use the Lèvene test. And, we will use the Kolmogorov-Smirnov test to evaluate the normality of distribution of each variable studied. According to the homogeneity and normality of distribution (Gaussian) of the studied variable will be used the appropriate statistical test (parametric or non-parametric) for each variable. In the homogeneous and Gaussian variables during rest, the analysis of variance (ANOVA) of a factor will be used to test the differences between the groups. In cases of significant F, the Scheffé post-hoc test will be performed for multiple comparisons. In non-homogeneous and / or non-Gaussian variables during rest, the Kruskal-Wallis test will be used, followed by the Dunn's test between the groups. On the other hand, in the homogeneous and Gaussian variables analyzed during the physiological maneuvers, the analysis of variance (ANOVA) of two factors will be used to test the differences between groups. In cases of significant F, the Scheffé post-hoc test will be performed for multiple comparisons. However, in non-homogeneous and / or non-Gaussian variables analyzed during physiological maneuvers, the Wilcoxon (paired data) and Mann-Whitney (unpaired data) tests, when appropriate, will be used. Will be considered as statistically significant to differences with P values <0.05.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Neurological patients (GCS 5 and under) of any cause, gender or age.
Key inclusion criteria (1 listed)
- Patients whose underwent ICP monitoring displaying both ICP curves and values.
Key exclusion criteria (1 listed)
- Patients whose display absence of insonation window
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 |
|---|---|---|
| Transcranial Doppler (TCD) ultrasound monitoringTCD monitoring comatose patients in ICU looking for signs of impaired cerebral compliance | Diagnostic test | – |
| Non invasive intracranial compliance monitoringA sensor of cardiac beat by beat cranial dilation will be used for monitoring intracranial compliance, in non-invasive fashion. | Diagnostic test | – |
Primary outcome
Impaired cerebral compliance
Time frame: 10 minutes
Performing ICP and TCD monitoring simultaneously during jugular compression, matching waveform behavior through computer software QL Online
2 secondary outcomes
Impaired cerebral auto-regulation
Time frame: 10 minutes
Non-invasive intracranial compliance monitoring
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
- Background: PubMed 20807427Dahlqvist MB, Andres RH, Raabe A, Jakob SM, Takala J, Dunser MW. Brain herniation in a patient with apparently normal intracranial pressure: a case report. J Med Case Rep. 2010 Aug 31;4:297. doi: 10.1186/1752-1947-4-297.
- Background: PubMed 15226070Bellner J, Romner B, Reinstrup P, Kristiansson KA, Ryding E, Brandt L. Transcranial Doppler sonography pulsatility index (PI) reflects intracranial pressure (ICP). Surg Neurol. 2004 Jul;62(1):45-51; discussion 51. doi: 10.1016/j.surneu.2003.12.007.
- Background: PubMed 26140576O'Brien NF, Maa T, Reuter-Rice K. Noninvasive screening for intracranial hypertension in children with acute, severe traumatic brain injury. J Neurosurg Pediatr. 2015 Oct;16(4):420-5. doi: 10.3171/2015.3.PEDS14521. Epub 2015 Jul 3.
- Background: PubMed 18183564Hertzog MA. Considerations in determining sample size for pilot studies. Res Nurs Health. 2008 Apr;31(2):180-91. doi: 10.1002/nur.20247.
- Results publication: PubMed 23128012Paschoal FM Jr, Bor-Seng-Shu E, Teixeira MJ. Transcranial Doppler ultrasonography with jugular vein compression can detect impairment of intracranial compliance. Clin Neurol Neurosurg. 2013 Jul;115(7):1196-8. doi: 10.1016/j.clineuro.2012.09.028. Epub 2012 Nov 3. No abstract available.
- Derived from this study: PubMed 41034684Kasprowicz M, Kazimierska A, Hendler M, Cardim D, Czosnyka Z, Czosnyka M, Paiva W, Brasil S. Invasive and Noninvasive Intracranial Pressure Pulse Waveform in Neurocritical Care Patients with Different Cranium Integrity. Neurocrit Care. 2026 Feb;44(1):282-293. doi: 10.1007/s12028-025-02382-2. Epub 2025 Oct 1.
- Derived from this study: PubMed 40659917Brasil S, Czosnyka M, Paiva WS, Frigieri G. Exploring Cerebrospinal Compensatory Zones Using a Noninvasive Approach. Neurocrit Care. 2025 Dec;43(3):834-841. doi: 10.1007/s12028-025-02320-2. Epub 2025 Jul 14.
- Derived from this study: PubMed 38355918de Moraes FM, Brasil S, Frigieri G, Robba C, Paiva W, Silva GS. ICP wave morphology as a screening test to exclude intracranial hypertension in brain-injured patients: a non-invasive perspective. J Clin Monit Comput. 2024 Aug;38(4):773-782. doi: 10.1007/s10877-023-01120-3. Epub 2024 Feb 14.
- Derived from this study: PubMed 37932509Brasil S, Romeijn H, Haspels EK, Paiva W, Schaafsma A. Improved Transcranial Doppler Waveform Analysis for Intracranial Hypertension Assessment in Patients with Traumatic Brain Injury. Neurocrit Care. 2024 Jun;40(3):931-940. doi: 10.1007/s12028-023-01849-4. Epub 2023 Nov 6.
- Derived from this study: PubMed 36703025Frigieri G, Robba C, Machado FS, Gomes JA, Brasil S. Application of non-invasive ICP waveform analysis in acute brain injury: Intracranial Compliance Scale. Intensive Care Med Exp. 2023 Jan 27;11(1):5. doi: 10.1186/s40635-023-00492-9. No abstract available.
- Derived from this study: PubMed 36399214Brasil S, Frigieri G, Taccone FS, Robba C, Solla DJF, de Carvalho Nogueira R, Yoshikawa MH, Teixeira MJ, Malbouisson LMS, Paiva WS. Noninvasive intracranial pressure waveforms for estimation of intracranial hypertension and outcome prediction in acute brain-injured patients. J Clin Monit Comput. 2023 Jun;37(3):753-760. doi: 10.1007/s10877-022-00941-y. Epub 2022 Nov 18.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Hypertension, run by University of Sao Paulo at 1 site in Brazil.
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 1 inclusion and 1 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 30 Sep 2022. 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 Brazil. 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 Sergio Brasil, MDMSc (+5511981210990, sbrasil@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impaired cerebral compliance (time frame: 10 minutes). 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 NCT03144219, which also lists 11 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 30 Sep 2022.