- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01173263
Effect of Bispectral Index (BIS) Titrated Propofol Sedation on Lower Esophageal Sphincter Pressures and Esophageal Function in Intensive Care Patients
Effect of BIS Titrated Propofol Sedation on Lower Esophageal Sphincter Pressures and Esophageal Function in Intensive Care Patients
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
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Ohio
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Cleveland, Ohio, Stati Uniti, 44195
- Cleveland Clinic
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Comparatore attivo: BIS 70
BIS levels of 70, will be targeted (Anxiolysis/high-frequency EEG activity, beta-augmentation);
|
Each patient will receive propofol sedation by continuous infusion titrated to a BIS level of 70.
Altri nomi:
|
Comparatore attivo: 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.
Altri nomi:
|
Comparatore attivo: 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.
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Deepening propofol sedation - as determined by BIS - lowers esophageal pressure in critical care patients.
Lasso di tempo: for 15 minutes after assigned BIS level has been maintained for one hour, while in the ICU
|
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.
|
for 15 minutes after assigned BIS level has been maintained for one hour, while in the ICU
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Deepening propofol sedation - as measured by Sedation Agitation Scale, Richmond Agitation Scale Score, and Ramsay sedation scale - lowers esophageal pressure in critical care patients.
Lasso di tempo: every 10 minutes, while sedated in the ICU
|
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.
|
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.
Lasso di tempo: for 15 minutes after assigned BIS level has been maintained for one hour, while in the ICU
|
Upper esophageal sphincter pressures, transient LES relaxations, and regurgitations will be evaluated by the GI team from recorded data from high resolution manometry.
|
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.
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 10-226
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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