CClinicalTrials.gg
Status unknownNCT02832908PULSATILITYUpdated Jul 14, 2016

Evaluation of the Physiopathological Phenomena and the Haemodynamic and Cerebral Metabolic Effects From Semi-seated Position to Lying Position in Patients With Brain Trauma

An interventional study of Change from semi-seated position to supine in Traumatic Brain Injury, sponsored by University Hospital, Montpellier. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-07-14.

Sponsored by University Hospital, Montpellier · Not applicable and Interventional

The sponsor has not verified this record recently (last verified Jul 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

Brain trauma is an important burden in traumatologic intensive care. In these patients the treatment is guided by a cluster of multimodal monitoring parameters. Despite this it is difficult to assess the actual physiopathologic status of the brain. Changing the position of these patients (semi-seated to lying position) causes changes in the hémodynamics brain conditions, so in monitoring parameters . The analysis of these changes can givr us valuable clinically informations.

Read the detailed description

Severe brain trauma (CGS \< 8 ) are included. PIC, PA, PVC, EKG, airway pressure, SjO2 and NIRSS are continuously monitored.

The patients are in semi seated (30°) position. Once a day they are in supine (0°) for 30 minutes. We record every parameters before and at the end of this supine period.

After time domain and frequency domain signal processing, this parameters are compared to deduct clinical relevant conclusions.

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Conditions studied

  • Traumatic Brain Injury
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In context

Brain Injuries

2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.

This study's planned enrollment of 90 is above the median of 48 across 1,331 interventional studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.

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

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patients with a severe head trauma estimated by the Glasgow Coma Scale and by the Glasgow Outcome Scale
  • age > 18

Exclusion criteria

Exclusion Criteria:

  • Other neurological pathology
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Study design

Phase
Not applicable
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
90 participants (estimated)

Study arms

  • Other
    Patients + parents

    Patients with severe head trauma

    Other: Change from semi-seated position to supine

Interventions

  • OtherChange from semi-seated position to supine

    from semi-seated position (30°) to lying position

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What researchers measure

Primary outcomes

  1. ASSESSMENT OF THE CEREBRAL OXYGENATION

    Time frame: UP TO 6 MONTHS

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Study locations

1 of 1 sites recruiting
  • Hôpital Lapeyronie - Département Anesthésie Réanimation A
    Montpellier, 34295, France
    • Jean Paul ROUSTAN, MD · Contact · jp-roustan@chu-montpellier.fr · 04 67 33 82 56
    • Jean Paul ROUSTAN, MD, phone 0467338256 · Principal investigator
    Recruiting
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References and documents

Publications

  • Dagod G, Roustan JP, Bringuier-Branchereau S, Ridolfo J, Martinez O, Capdevila X, Charbit J. Effect of a temporary lying position on cerebral hemodynamic and cerebral oxygenation parameters in patients with severe brain trauma. Acta Neurochir (Wien). 2021 Sep;163(9):2595-2602. doi: 10.1007/s00701-021-04851-x. Epub 2021 Jul 8. Erratum In: Acta Neurochir (Wien). 2023 Mar;165(3):595-597. doi: 10.1007/s00701-023-05528-3. PubMed 34236525 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 14, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02832908
Lead sponsor
University Hospital, Montpellier
Responsible party
Sponsor
First posted
Jul 14, 2016
Start date
Dec 2014
Primary completion
Dec 2016 (estimated)
Completion
Dec 2016 (estimated)
Last update
Jul 14, 2016

Study contacts

Jean Paul ROUSTAN, MD
Contact
jp-roustan@chu-montpellier.fr
0467338256

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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