- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02027857
Comparison of the Application in Traumatic Brain Edema Between EIT and Non-invasive ICP Monitoring (EIT)
2 januari 2014 uppdaterad av: 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.
Studieöversikt
Status
Okänd
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Förväntat)
60
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Shaanxi
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Xi'an City, Shaanxi, Kina, 710032
- Department of Neurosurgery, Xijing Hospital, Fourth Military Medical University
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
16 år till 65 år (Barn, Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Eligible patients were 16 to 65 years of age with all genders.
- The patients had been diagnosed as traumatic brain injury during 24 hours before enrollment, with the confirmation of CT or MRI.
- All the patients had provided written informed consent.
6. The patients were receiving usual inpatient rehabilitation and conservative treatment .
Exclusion Criteria:
- The patients with indication of operation during the research should be excluded.
- The patients were assessed as unqualified for the study according to the comprehensive evaluation opinion brought forward by the research team.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Inget ingripande: 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.
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Experimentell: 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.
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Övrig: 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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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brain electrical impedance
Tidsram: From the 1st day (enrollment) to the 7th day
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After the patients' enrollment, the electrodes would be placed properly and the continuous monitoring of brain impedance just be started.
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From the 1st day (enrollment) to the 7th day
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Glasgow coma scale(GCS)
Tidsram: on the 0 day of the study
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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).
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on the 0 day of the study
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demographic characteristics at baseline
Tidsram: on the 0 day of the study
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The demographic data include age, gender, injuries reason, time from injuries, and so on.
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on the 0 day of the study
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kidney function examination
Tidsram: On the 1st day, 3rd day, 5th and 7th day
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There are three main indicators: blood creatinine, urea nitrogen, and uric acid.
These indicator are used as a monitor of the kidney safety.
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On the 1st day, 3rd day, 5th and 7th day
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Physiological and pathological reflex check
Tidsram: on the 1st and 7th day
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on the 1st and 7th day
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muscular strength and tension test
Tidsram: on the 1st and 7th day
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There are 6 grades in muscular strength test.
And muscular tension test was referred to Modified Ashworth scale.
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on the 1st and 7th day
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non-invasive intracranial pressure
Tidsram: From the 1st day (enrollment) to the 7th day
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This equipment can continuously monitor the change of intracranial pressure since the patients' enrollment.
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From the 1st day (enrollment) to the 7th day
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brain CT scan
Tidsram: On the 1st day (enrollment), and 7th day
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Brain CT scan is applied to monitor the degree and progress of the brain change after the medication of mannitol.
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On the 1st day (enrollment), and 7th day
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Disability Rating Scale (DRS)
Tidsram: on the 1st day (enrollment), seventh day after hospitalization
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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.
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on the 1st day (enrollment), seventh day after hospitalization
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glasgow outcome scale(GOS)
Tidsram: the patients were discharged or the 7th day after hospitalization
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GOS includes 5 grades: Dead, Vegetative state, Severe disability, Moderate disability, Good recovery.
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the patients were discharged or the 7th day after hospitalization
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Fei Zhou, M.D.; Ph.D., Department of Neurosurgery, Xijing Hospital, Fourth Military Medical University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 januari 2014
Primärt slutförande (Förväntat)
1 januari 2015
Avslutad studie (Förväntat)
1 juni 2015
Studieregistreringsdatum
Först inskickad
23 december 2013
Först inskickad som uppfyllde QC-kriterierna
2 januari 2014
Första postat (Uppskatta)
6 januari 2014
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
6 januari 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
2 januari 2014
Senast verifierad
1 januari 2014
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 20131211-8
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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