Effect of Bispectral Index (BIS) Titrated Propofol Sedation on Lower Esophageal Sphincter Pressures and Esophageal Function in Intensive Care Patients
4 mars 2014 uppdaterad av: Alparslan Turan, The Cleveland Clinic
Effect of BIS Titrated Propofol Sedation on Lower Esophageal Sphincter Pressures and Esophageal Function in Intensive Care Patients
Eligible patients will be allocated to receive propofol sedation titrated to 3 different Bispectral Index (BIS) levels in a random order.
Primary hypothesis: Deepening propofol sedation - as determined by BIS - lowers esophageal pressure in critical care patients.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Patient will be selected from the ICU, based on the defined inclusion and exclusion criteria. Potential study subjects will be screened by the research fellow or the on-site study co-investigator. Eligible patients will be allocated to receive propofol sedation titrated to 3 different BIS levels in a random order. BIS XP monitors (Aspect Medical Systems, Norwood, MA, USA) will be used which are relatively resistant to EMG artifact; a BIS sensor will be position on forehead of the patient after the skin is degreased and gently abraded. Esophageal pressure monitoring will be performed by a catheter inserted from the nose to the esophagus and left there trough the study period.
If patients are on sedation they will be placed on propofol sedation for a washout period. Each patient will receive propofol sedation by continuous infusion titrated to a different levels of BIS in a randomized fashion according to a computer-generated random-number sequence;
- BIS levels of 70, will be targeted (Anxiolysis/high-frequency EEG activity, beta-augmentation);
- BIS levels of 50 will be targeted, (Low frequency EEG activity, theta-delta activity);
- BIS levels of 35 will be targeted (low frequency EEG activity). A propofol infusion will be titrated by the investigators to the designated BIS target according to randomization. Clinical personnel will not be blinded to the study, and if patient has clinically significant change in hemodynamic parameters study will be interrupted. Each BIS target level will be kept as constant as possible for at least one hour; thereafter, lower esophageal pressures will be recorded for 15 minutes using high resolution esophageal manometry. Studies will be done in supine position [Most ICU patients are now kept head-up.], and the manometric assembly will be positioned to record from the hypopharynx to the stomach with 4-6 of the sensors positioned in the stomach.
All patients will otherwise receive routine ICU care and medications without interruption of standard clinical care.
Studietyp
Interventionell
Inskrivning (Faktisk)
1
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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Ohio
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Cleveland, Ohio, Förenta staterna, 44195
- Cleveland Clinic
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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
18 år till 80 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- 18-80 years of age
- Written informed consent from relatives
- Clinically stable
- Mechanically ventilated < 2days
- Require sedation and expected to be given propofol
Exclusion Criteria:
- Recent injury or other pathologic condition of the esophagus
- Major bronchopleural fistula
- History of liver failure
- History of renal failure
- History of major neuromuscular disease
- Multiple trauma
- Upper motor nerve injury
- Hypersensitivity to propofol
- Recent gastrointestinal surgery
- Patients with a diagnosed or suspected condition that may give false results in BIS monitoring.
- Tracheostomized patients
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: BIS 70
BIS levels of 70, will be targeted (Anxiolysis/high-frequency EEG activity, beta-augmentation);
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Each patient will receive propofol sedation by continuous infusion titrated to a BIS level of 70.
Andra namn:
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Aktiv komparator: BIS 50
BIS levels of 50 will be targeted, (Low frequency EEG activity, theta-delta activity)
|
Each patient will receive propofol sedation by continuous infusion titrated to a BIS level of 50.
Andra namn:
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Aktiv komparator: BIS 35
BIS levels of 35 will be targeted (low frequency EEG activity)
|
Each patient will receive propofol sedation by continuous infusion titrated to a BIS level of 35.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Deepening propofol sedation - as determined by BIS - lowers esophageal pressure in critical care patients.
Tidsram: for 15 minutes after assigned BIS level has been maintained for one hour, while in the ICU
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Sedation will also be evaluated with the bispectral index of the electroencephalogram. BIS of the EEG data will be acquired with 4 BIS-sensor electrodes and a BIS XP monitor.
The BIS will be recorded electronically at one-minute intervals.
Heart rate, blood pressures (diastolic and systolic), respiratory rate, core temperature and oxygen saturation will be recorded every 5 minutes during the measurement period of the study.
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for 15 minutes after assigned BIS level has been maintained for one hour, while in the ICU
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Deepening propofol sedation - as measured by Sedation Agitation Scale, Richmond Agitation Scale Score, and Ramsay sedation scale - lowers esophageal pressure in critical care patients.
Tidsram: every 10 minutes, while sedated in the ICU
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The SAS uses a 1 to 7 point scale to make a determination of the patient's level of agitation and sedation from a rating of 7 dangerously agitated to a rating of 1 unarousable (Table 1).
Clinical sedation assessments using SAS and RASS scales will be measured every 10 minutes through the study period.
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every 10 minutes, while sedated in the ICU
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Modifying the target level of BIS titration affects upper esophageal pressures and esophageal peristalsis.
Tidsram: for 15 minutes after assigned BIS level has been maintained for one hour, while in the ICU
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Upper esophageal sphincter pressures, transient LES relaxations, and regurgitations will be evaluated by the GI team from recorded data from high resolution manometry.
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for 15 minutes after assigned BIS level has been maintained for one hour, while in the ICU
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There is an association between ventilator associated pneumonia and baseline lower esophageal and barrier pressure.
Tidsram: daily, until hospital discharge
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Patients will be followed for their stay in the hospital for occurrence of ventilator associated pneumonia.
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daily, until hospital discharge
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Samarbetspartners och utredare
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Sponsor
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 juli 2010
Primärt slutförande (Faktisk)
1 mars 2011
Avslutad studie (Faktisk)
1 mars 2011
Studieregistreringsdatum
Först inskickad
21 juli 2010
Först inskickad som uppfyllde QC-kriterierna
30 juli 2010
Första postat (Uppskatta)
2 augusti 2010
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
5 mars 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
4 mars 2014
Senast verifierad
1 mars 2014
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 10-226
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