CClinicalTrials.gg
Status unknownNCT03087981PANDAUpdated Sep 15, 2017

Parameters Analysis in Neurosurgical Critical Patients Through Big Data Acquisition

An observational study in Intracranial Pressure, Neurosurgery and Information Management, sponsored by RenJi Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-09-15.

Sponsored by RenJi Hospital · Observational

The sponsor has not verified this record recently (last verified Mar 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
120
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The PANDA trial is a multicenter prospective observational study designed to analyze various ICP derived parameters and clinical status in neurosurgical critical patients through a new big data acquisition system.

Read the detailed description

Nowadays, intracranial pressure (ICP) monitoring is widely used as a way to evaluate intracranial status in neurosurgery department especially in neurosurgical critical patients. Most of us focus only on the mean ICP value while ignoring other ICP derived parameters, such ICP waveform, AMP, RAP, PRx, IAAC and so on. However, it is reported that these parameters can reflect the status of intracerebral circulation, cerebrospinal compensatory reserve and brain compliance and can often be indicative of impending neurological deterioration and even outcome of patients. The PANDA trial is a multicenter prospective observational study designed to investigate the relationship between these ICP derived parameters and clinical status and to uncover the mechanism behind it. We will use a brand-new automatic big data collecting and storing system to continuously acquire patients' physiological information such as blood pressure, ICP, ETCO2,EEG etc. before analysis. Hopefully, this trial will reveal what is happening in the cranial cavity through the natural history of different kinds of intracranial lesion.

02

Conditions studied

  • Intracranial Pressure
  • Neurosurgery
  • Information Management
03

In context

Lead sponsor

RenJi Hospital is the lead sponsor of 535 studies on the registry; 244 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

patients with intracranial lesion

Inclusion criteria

  • Age 18-65 years old
  • Intracranial lesion underwent ICP sensor implantation
  • Informed consent obtained

Exclusion criteria

Exclusion Criteria:

  • No consent
  • A life-threatening injury to an organ other than the brain
  • Known pregnancy
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
120 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Glasgow Outcome Scale(GOS)

    Time frame: within 3 months after enrollment

  2. Glasgow Coma Scale(GCS)

    Time frame: within 3 months after enrollment

  3. Disability Rating Scale (DRS)

    Time frame: within 3 months after enrollment

  4. Mean intracranial pressure(ICP) value

    Time frame: throughout ICP monitoring, average 7 days

  5. Correlation between pulse amplitude and mean intracranial pressure(RAP)

    Time frame: throughout ICP monitoring, average 7 days

  6. Pressure-reactivity index(PRx)

    Time frame: throughout ICP monitoring, average 7 days

  7. Pulse amplitude of ICP(AMP)

    Time frame: throughout ICP monitoring, average 7 days

  8. ICP-arterial blood pressure(ABP) wave amplitude correlation(IAAC)

    Time frame: throughout ICP monitoring, average 7 days

  9. Cerebral perfusion pressure(CPP)

    Time frame: throughout ICP monitoring, average 7 days

07

Study locations

1 of 1 sites recruiting
  • Department of Neurosurgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University
    Shanghai, Shanghai 200127, China
    • Guoyi Gao, M.D. · Contact · guoyigao@gmail.com · +86-021-68383709
    • Guoyi Gao, M.D. · Principal investigator
    Recruiting
08

References and documents

Publications

  • Di Ieva A, Schmitz EM, Cusimano MD. Analysis of intracranial pressure: past, present, and future. Neuroscientist. 2013 Dec;19(6):592-603. doi: 10.1177/1073858412474845. Epub 2013 Feb 6. PubMed 23389057 ↗
  • Eide PK, Sorteberg A, Bentsen G, Marthinsen PB, Stubhaug A, Sorteberg W. Pressure-derived versus pressure wave amplitude-derived indices of cerebrovascular pressure reactivity in relation to early clinical state and 12-month outcome following aneurysmal subarachnoid hemorrhage. J Neurosurg. 2012 May;116(5):961-71. doi: 10.3171/2012.1.JNS111313. Epub 2012 Feb 10. PubMed 22324419 ↗
  • Czosnyka M, Smielewski P, Timofeev I, Lavinio A, Guazzo E, Hutchinson P, Pickard JD. Intracranial pressure: more than a number. Neurosurg Focus. 2007 May 15;22(5):E10. doi: 10.3171/foc.2007.22.5.11. PubMed 17613228 ↗
  • Czosnyka M, Pickard JD. Monitoring and interpretation of intracranial pressure. J Neurol Neurosurg Psychiatry. 2004 Jun;75(6):813-21. doi: 10.1136/jnnp.2003.033126. PubMed 15145991 ↗
  • Hamilton R, Xu P, Asgari S, Kasprowicz M, Vespa P, Bergsneider M, Hu X. Forecasting intracranial pressure elevation using pulse waveform morphology. Annu Int Conf IEEE Eng Med Biol Soc. 2009;2009:4331-4. doi: 10.1109/IEMBS.2009.5332749. PubMed 19963821 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03087981
Lead sponsor
RenJi Hospital
Responsible party
Sponsor
First posted
Mar 23, 2017
Start date
Oct 2017 (estimated)
Primary completion
Apr 2018 (estimated)
Completion
Jul 2018 (estimated)
Last update
Sep 15, 2017

Study contacts

Guoyi Gao, Dr.
Contact
guoyigao@gmail.com
+86-021-68383709

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion