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Comparison of the Application in Traumatic Brain Edema Between EIT and Non-invasive ICP Monitoring (EIT)

2. januar 2014 opdateret af: Xijing Hospital

Comparison of the Application in Traumatic Brain Edema Between Electrical Impedance Tomography and Non-invasive Intracranial Pressure Monitoring

Brain edema is the main reason for the disability and lethality in traumatic brain injury, which is the most difficult part of emergency rescue. Recently, there is no medical equipment to monitor the early brain edema in clinic. We have found that Electrical impedance tomography (EIT) can perform the real-time and bedside monitoring of brain electrical impedance after single-dose mannitol treatment, which may be a new strategy for the surveillance of brain edema. In this study, we would like to compare the application in traumatic brain edema between EIT and Noninvasive intracranial pressure (ICP) monitoring, including the progress of brain edema, the relationship between impedance and ICP, and the improvement for the patients' prognosis. EIT would probably be a new image strategy for the treatment of traumatic brain injury.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Kina
    • Shaanxi
      • Xi'an City, Shaanxi, Kina, 710032
        • Department of Neurosurgery, Xijing Hospital, Fourth Military Medical University
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Hu Shijie, M.D.,Ph.D.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

16 år til 65 år (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Eligible patients were 16 to 65 years of age with all genders.
  2. The patients had been diagnosed as traumatic brain injury during 24 hours before enrollment, with the confirmation of CT or MRI.
  3. All the patients had provided written informed consent.

6. The patients were receiving usual inpatient rehabilitation and conservative treatment .

Exclusion Criteria:

  1. The patients with indication of operation during the research should be excluded.
  2. The patients were assessed as unqualified for the study according to the comprehensive evaluation opinion brought forward by the research team.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: mannitol empirical therapy
There would be 20 patients in this group, who would be given mannitol to relieve the brain edema depending on the empirical therapy by doctors.
Eksperimentel: EIT monitoring
There would be 20 patients in this group, who would be given mannitol to relieve the brain edema depending on the results of Electrical impedance tomography monitoring.
Enhed: EIT monitoring
Andet: non-invasive ICP monitoring
There would be 20 patients in this group, who would be given mannitol to relieve the brain edema depending on the results of non-invasive intracranial pressure monitoring.
Enhed: non-invasive ICP monitoring

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
brain electrical impedance
Tidsramme: From the 1st day (enrollment) to the 7th day
After the patients' enrollment, the electrodes would be placed properly and the continuous monitoring of brain impedance just be started.
From the 1st day (enrollment) to the 7th day

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Glasgow coma scale(GCS)
Tidsramme: on the 0 day of the study
The scale is composed of three tests: eye, verbal and motor responses. The three values separately as well as their sum are considered. The lowest possible GCS (the sum) is 3 (deep coma or death), while the highest is 15 (fully awake person).
on the 0 day of the study
demographic characteristics at baseline
Tidsramme: on the 0 day of the study
The demographic data include age, gender, injuries reason, time from injuries, and so on.
on the 0 day of the study
kidney function examination
Tidsramme: On the 1st day, 3rd day, 5th and 7th day
There are three main indicators: blood creatinine, urea nitrogen, and uric acid. These indicator are used as a monitor of the kidney safety.
On the 1st day, 3rd day, 5th and 7th day
Physiological and pathological reflex check
Tidsramme: on the 1st and 7th day
on the 1st and 7th day
muscular strength and tension test
Tidsramme: on the 1st and 7th day
There are 6 grades in muscular strength test. And muscular tension test was referred to Modified Ashworth scale.
on the 1st and 7th day
non-invasive intracranial pressure
Tidsramme: From the 1st day (enrollment) to the 7th day
This equipment can continuously monitor the change of intracranial pressure since the patients' enrollment.
From the 1st day (enrollment) to the 7th day
brain CT scan
Tidsramme: On the 1st day (enrollment), and 7th day
Brain CT scan is applied to monitor the degree and progress of the brain change after the medication of mannitol.
On the 1st day (enrollment), and 7th day
Disability Rating Scale (DRS)
Tidsramme: on the 1st day (enrollment), seventh day after hospitalization
The DRS includes measures of eye opening, verbalization, and motor response (derived from the Glasgow Coma Scale); cognitive understanding of feeding, dressing, and grooming; degree of assistance and supervision required; and employability. Scores range from 0 to 29, with higher values indicating greater disability.
on the 1st day (enrollment), seventh day after hospitalization
glasgow outcome scale(GOS)
Tidsramme: the patients were discharged or the 7th day after hospitalization
GOS includes 5 grades: Dead, Vegetative state, Severe disability, Moderate disability, Good recovery.
the patients were discharged or the 7th day after hospitalization

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Xijing Hospital

Efterforskere

  • Studieleder: Fei Zhou, M.D.; Ph.D., Department of Neurosurgery, Xijing Hospital, Fourth Military Medical University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2014

Primær færdiggørelse (Forventet)

1. januar 2015

Studieafslutning (Forventet)

1. juni 2015

Datoer for studieregistrering

Først indsendt

23. december 2013

Først indsendt, der opfyldte QC-kriterier

2. januar 2014

Først opslået (Skøn)

6. januar 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. januar 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. januar 2014

Sidst verificeret

1. januar 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 20131211-8

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Brain Electrical Impedance;

Kliniske forsøg med EIT monitoring

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