外傷性脳損傷の ICU 患者に対する経皮的耳介神経刺激 (tAN-TBI)
外傷性脳損傷 (tAN-TBI) の ICU 患者への経皮的耳介神経刺激 (tAN) の実施
The overarching goal of this pilot study is to assess the feasibility and safety of transcutaneous auricular neurostimulation (tan) in ICU patients with TBi and to determine the effect of tan on serum markers of inflammation. exploratory analyses will examine effects on such physiological parameters as blood pressure, heart rate, and intracranial pressure (iCP), as well as measures of neurological function.
調査の概要
詳細な説明
This is a single-center, open-label, nonrandomized investigation. TBI patients with a post resuscitation Glasgow Coma Scale (GCS) score of 12 or less (commonly described as moderate or severe TBI) and acute traumatic intradural blood on head CT scan will be screened upon admission to the ICU at Parkland Memorial Hospital. It is expected that all or almost all subjects will be in the Neuroscience or Surgical ICU. Consent for participation will be sought from the subject's legally authorized representative. Exception from informed consent or waiver of consent will not be part of this study.
tAN will begin as soon as feasible after subject enrollment. Immediately prior to this intervention, vital signs, neurologic status, and other clinical parameters will be recorded, and pre-tAN blood will be collected for measurement of serum inflammatory markers. tAN will be administered for 30 minutes under the supervision of a member of the research team. After 30 minutes (just prior to stopping tAN), the same clinical parameters that were recorded at baseline will again be recorded then tAN will be stopped. Approximately two hours after tAN has ended, a post-tAN blood sample will be collected for measurement of the same inflammatory markers as in the pre-tAN blood sample. At each timepoint for blood collection, additional blood may be collected for banking and future analyses.
Patients will undergo research blood draws and tAN stimulation for a maximum of 10 days. Research-related procedures will not exceed this 10-day period.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Alex Valadka, MD
- 電話番号：2146452300
- メール：alex.valadka@utsouthwestern.edu
研究連絡先のバックアップ
- 名前：Aisha Qureshi
- 電話番号：2146489905
- メール：Aisha.Qureshi@UTSouthwestern.edu
研究場所
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Texas
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Dallas、Texas、アメリカ、75390
- 募集
- UT Southwestern Medical Center
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コンタクト：
- Alex Valadka, MD
- 電話番号：214-645-2300
- メール：alex.valadka@utsouthwestern.edu
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コンタクト：
- Tyfe Oderinde, MS
- 電話番号：214-648-9905
- メール：bolutyfe.oderinde@utsouthwestern.edu
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Dallas、Texas、アメリカ、75235
- 募集
- Parkland Health & Hospital System
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コンタクト：
- Alex Valadka, MD
- 電話番号：214-645-2300
- メール：alex.valadka@utsouthwestern.edu
-
コンタクト：
- Tyfe Oderinde, MS
- 電話番号：214-648-9905
- メール：bolutyfe.oderinde@utsouthwestern.edu
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Post-resuscitation GCS score 12 or below and acute trauma-related intradural blood on head CT scan after TB
- Age 18 years or older (pediatric trauma patients are not routinely transported to Parkland)
- Consent from legally authorized representative
Exclusion Criteria:
- Hemodynamic instability
- Expected imminent mortality because of overwhelming neurological and/or systemic injury
- Unclear neurological status because of paralytic medications or intoxication with ethanol or other drugs
- Presence of other electrical stimulation devices (pacemaker, cochlear prosthesis, neurostimulator, etc.)
- Abnormal ear anatomy or ear infection
- Participant is pregnant or lactating
- Any other significant medical or psychosocial problems that, in the opinion of the investigator, would potentially cause harm to the participant, impact their ability to participate, or influence the results of the trial
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Determine the effect of tAN on serum concentrations of inflammatory mediators in TBI patients
Subjects will receive treatment upon providing informed consent and will undergo transcutaneous auricular neurostimulation (tAN) once daily during their ICU stay, with the treatment duration not exceeding 10 days. Two blood samples will be collected daily: one before the tAN session and another two hours after the session. Participant data will be collected daily throughout the ICU stay. Additionally, surveys will be collected from registered nurses providing direct care to TBI patients enrolled in the tAN-TBI study to assess the compatibility of tAN with patient care processes in the ICU. |
This method of simultaneous vagal and trigeminal stimulation via the external ear is known as transcutaneous auricular neurostimulation (tAN), as the targets of electrical stimulation include the auricular branch of the vagus nerve (ABVN) and auriculotemporal nerve (ATN), which is a branch of the mandibular division of the trigeminal nerve. Electrodes applied to select dermatome regions can target ear neural structures and deliver non-invasive vagus nerve stimulation (VNS) and trigeminal nerve stimulation (TNS). |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Survey nursing attitudes towards daily tAN and the compatibility of tAN with standard patient care activities in the ICU; Examine the safety of tAN in ICU patients.
時間枠：Registered nurses can complete the Sparrow Ascent ICU User Acceptance Questionnaire at Day 1- Day 10, or before the TBI patient is discharged from the hospital, or ICU. It may not be completed on Day 11 or after the patient has been discharged.
|
Registered nurses providing direct care to ICU patients receiving tAN will be asked to complete the Sparrow Ascent ICU User Acceptance Questionnaire to assess the compatibility of tAN with patient care. |
Registered nurses can complete the Sparrow Ascent ICU User Acceptance Questionnaire at Day 1- Day 10, or before the TBI patient is discharged from the hospital, or ICU. It may not be completed on Day 11 or after the patient has been discharged.
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Determine the effect of tAN on serum concentrations of inflammatory mediators in TBI patients.
時間枠：TBI patients will receive tAN stimulation once per day and will not exceed 10 days.
|
Every effort will be made to initiate tAN as soon after injury as possible in order to capture early postinjury data on the effectiveness of tAN and to inform the design of future studies. |
TBI patients will receive tAN stimulation once per day and will not exceed 10 days.
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|
Explore the effect of tAN on Blood Pressure
時間枠：Data will be collected upon consent, twice daily from Day 1 to Day 10, or until the patient is discharged from the hospital. Data will not be collected past 10 days.
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Blood pressure (mmHg) will be checked twice daily, pre-tAN and 30 minutes post-tAN |
Data will be collected upon consent, twice daily from Day 1 to Day 10, or until the patient is discharged from the hospital. Data will not be collected past 10 days.
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|
Explore the effect of tAN on Heart Rate
時間枠：Data will be collected upon consent, twice daily from Day 1 to Day 10, or until the patient is discharged from the hospital. Data will not be collected past 10 days.
|
Heart rate (bpm) will be checked twice daily, pre-tAN and 30 minutes post-tAN |
Data will be collected upon consent, twice daily from Day 1 to Day 10, or until the patient is discharged from the hospital. Data will not be collected past 10 days.
|
|
Explore the effect of tAN on Respiratory Rate (and ventilator settings and use of noninvasive oxygenation and ventilation if applicable)
時間枠：Data will be collected upon consent, twice daily from Day 1 to Day 10, or until the patient is discharged from the hospital. Data will not be collected past 10 days.
|
Respiratory rate (bpm) will be checked twice daily, pre-tAN and 30 minutes post-tAN |
Data will be collected upon consent, twice daily from Day 1 to Day 10, or until the patient is discharged from the hospital. Data will not be collected past 10 days.
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Explore the effect of tAN on Temperature
時間枠：Data will be collected upon consent, twice daily from Day 1 to Day 10, or until the patient is discharged from the hospital. Data will not be collected past 10 days.
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Temperature (°C/°F) will be checked twice daily, pre-tAN and 30 minutes post-tAN |
Data will be collected upon consent, twice daily from Day 1 to Day 10, or until the patient is discharged from the hospital. Data will not be collected past 10 days.
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Explore the effect of tAN on Intracranial pressure
時間枠：Data will be collected upon consent, twice daily from Day 1 to Day 10, or until the patient is discharged from the hospital. Data will not be collected past 10 days.
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Intracranial pressure (mmHg) will be checked twice daily, pre-tAN and 30 minutes post-tAN |
Data will be collected upon consent, twice daily from Day 1 to Day 10, or until the patient is discharged from the hospital. Data will not be collected past 10 days.
|
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Explore the effect of tAN on Brain Tissue Oxygen Tension (PbtO2)
時間枠：Data will be collected upon consent, twice daily from Day 1 to Day 10, or until the patient is discharged from the hospital. Data will not be collected past 10 days.
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Brain Tissue Oxygen Tension (mmHg) will be checked twice daily, pre-tAN and 30 minutes post-tAN |
Data will be collected upon consent, twice daily from Day 1 to Day 10, or until the patient is discharged from the hospital. Data will not be collected past 10 days.
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Explore the effect of tAN on Glasgow Coma Scale (GCS) (and any sedatives or analgesics that could affect neurological assessment)
時間枠：Data will be collected upon consent, twice daily from Day 1 to Day 10, or until the patient is discharged from the hospital. Data will not be collected past 10 days.
|
GCS (and any sedatives or analgesics that could affect neurological assessment) will be checked twice daily, pre-tAN and 30 minutes post-tAN. Scale from 3 to 15, where 3 represents deep unconsciousness and 15 indicates full consciousness. |
Data will be collected upon consent, twice daily from Day 1 to Day 10, or until the patient is discharged from the hospital. Data will not be collected past 10 days.
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Explore the effect of tAN on Pupillary Diameter
時間枠：Data will be collected upon consent, twice daily from Day 1 to Day 10, or until the patient is discharged from the hospital. Data will not be collected past 10 days.
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Pupillary Diameter (mm) will be checked twice daily, pre-tAN and 30 minutes post-tAN |
Data will be collected upon consent, twice daily from Day 1 to Day 10, or until the patient is discharged from the hospital. Data will not be collected past 10 days.
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Explore the effect of tAN on Neurological Pupil index (NPi) via pupillometry
時間枠：Data will be collected upon consent, twice daily from Day 1 to Day 10, or until the patient is discharged from the hospital. Data will not be collected past 10 days.
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Neurological Pupil index (NPi) via pupillometry dimensionless index, typically ranging from 0 to 5. This will be checked twice daily, pre-tAN and 30 minutes post-tAN |
Data will be collected upon consent, twice daily from Day 1 to Day 10, or until the patient is discharged from the hospital. Data will not be collected past 10 days.
|
協力者と研究者
捜査官
- 主任研究者：Alex Valadka, MD、University of Texas Southwestern Medical Center
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。