Respiration, ArtificialNCT01173263
Effect of Bispectral Index (BIS) Titrated Propofol Sedation on Lower Esophageal Sphincter Pressures and Esophageal Function in Intensive Care Patients
A study testing BIS 70 maintained, BIS level 50 and BIS 35 in people with Respiration, Artificial, run by The Cleveland Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Respiration, Artificial
- What is being tested?
- BIS 70 maintained, BIS level 50 and BIS 35
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Mar 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-80 years of age
- Written informed consent from relatives
- Clinically stable
- Mechanically ventilated < 2days
- Require sedation and expected to be given propofol
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Respiration, Artificial
- Being tested
- BIS 70 maintained, BIS level 50, BIS 35
- Keywords
- breathing machine, mechanical ventilator
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIS 70 maintainedOther
Also called sedation, propofol, BIS monitor, esophageal pressure
Each patient will receive propofol sedation by continuous infusion titrated to a BIS level of 70.
BIS level 50Other
Also called sedation, propofol, BIS monitor, esophageal pressure
Each patient will receive propofol sedation by continuous infusion titrated to a BIS level of 50.
BIS 35Other
Also called sedation, propofol, BIS monitor, esophageal pressure
Each patient will receive propofol sedation by continuous infusion titrated to a BIS level of 35.
| Study group | Role | What they receive |
|---|---|---|
| BIS 70 | Active comparator | BIS levels of 70, will be targeted (Anxiolysis/high-frequency EEG activity, beta-augmentation); Receives: Other: BIS 70 maintained |
| BIS 50 | Active comparator | BIS levels of 50 will be targeted, (Low frequency EEG activity, theta-delta activity) Receives: Other: BIS level 50 |
| BIS 35 | Active comparator | BIS levels of 35 will be targeted (low frequency EEG activity) Receives: Other: BIS 35 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Deepening propofol sedation - as determined by BIS - lowers esophageal pressure in critical care patients.
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.
Measured: for 15 minutes after assigned BIS level has been maintained for one hour, while in the ICU
Secondary outcomes (3)
Deepening propofol sedation - as measured by Sedation Agitation Scale, Richmond Agitation Scale Score, and Ramsay sedation scale - lowers esophageal pressure in critical care patients.
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.
Measured: every 10 minutes, while sedated in the ICU
Modifying the target level of BIS titration affects upper esophageal pressures and esophageal peristalsis.
Upper esophageal sphincter pressures, transient LES relaxations, and regurgitations will be evaluated by the GI team from recorded data from high resolution manometry.
Measured: for 15 minutes after assigned BIS level has been maintained for one hour, while in the ICU
There is an association between ventilator associated pneumonia and baseline lower esophageal and barrier pressure.
Patients will be followed for their stay in the hospital for occurrence of ventilator associated pneumonia.
Measured: daily, until hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2010 (estimated)
- Study startJul 2010
- Primary completionMar 2011
- Study completionMar 2011
Why it stopped: recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiration, ArtificialStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alparslan Turan, The Cleveland Clinic
- Investigators
- Alparslan Turan, M.D., Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01173263
- Sponsor's protocol ID
- 10-226
- Status last verified
- Mar 2014
- First submitted
- 21 Jul 2010
- Last updated
- 5 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of BIS Titrated Propofol Sedation on Lower Esophageal Sphincter Pressures and Esophageal Function in Intensive Care Patients
- ClinicalTrials.gov ID
- NCT01173263
- Acronym / sponsor ID
- 10-226
- Conditions
- Respiration, Artificial
- Keywords
- breathing machine, mechanical ventilator
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment difficulties
- Enrolment
- 1 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 2 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BIS 70 | Active comparator | Other: BIS 70 maintainedBIS levels of 70, will be targeted (Anxiolysis/high-frequency EEG activity, beta-augmentation); |
| BIS 50 | Active comparator | Other: BIS level 50BIS levels of 50 will be targeted, (Low frequency EEG activity, theta-delta activity) |
| BIS 35 | Active comparator | Other: BIS 35BIS levels of 35 will be targeted (low frequency EEG activity) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18-80 years of age
- Written informed consent from relatives
- Clinically stable
- Mechanically ventilated < 2days
- Require sedation and expected to be given propofol
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIS 70 maintainedAlso: sedation, propofol, BIS monitor, esophageal pressureEach patient will receive propofol sedation by continuous infusion titrated to a BIS level of 70. | Other | BIS 70 |
| BIS level 50Also: sedation, propofol, BIS monitor, esophageal pressureEach patient will receive propofol sedation by continuous infusion titrated to a BIS level of 50. | Other | BIS 50 |
| BIS 35Also: sedation, propofol, BIS monitor, esophageal pressureEach patient will receive propofol sedation by continuous infusion titrated to a BIS level of 35. | Other | BIS 35 |
Primary outcome
Deepening propofol sedation - as determined by BIS - lowers esophageal pressure in critical care patients.
Time frame: 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.
3 secondary outcomes
Deepening propofol sedation - as measured by Sedation Agitation Scale, Richmond Agitation Scale Score, and Ramsay sedation scale - lowers esophageal pressure in critical care patients.
Time frame: every 10 minutes, while sedated in the ICU
Modifying the target level of BIS titration affects upper esophageal pressures and esophageal peristalsis.
Time frame: for 15 minutes after assigned BIS level has been maintained for one hour, while in the ICU
There is an association between ventilator associated pneumonia and baseline lower esophageal and barrier pressure.
Time frame: daily, until hospital discharge
Results and safety
The study was stopped early (reason given: recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2014.
Related trials for Respiration, Artificial
Not yet recruiting
Miniature In-line Respirator
Brain Death, Respiration, Artificial
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
RecruitingObservational study
Development and Clinical Validation of Artificial Intelligence Algorithms for Sleep Staging and Obstructive Sleep Apnea Screening Based on a Large-Scale Model Trained on Multimodal Physiological Signals From Diverse Populations
Sleep Apnea, Obstructive, Sleep Staging
Not yet recruitingObservational study
Development and Prospective Validation of the AutoEIT Foundation Model for ARDS
ARDS (Acute Respiratory Distress Syndrome), Respiratory Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alparslan Turan, M.D. principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BIS 70 maintained, BIS level 50 and BIS 35 in people with Respiration, Artificial, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: recruitment difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Deepening propofol sedation - as determined by BIS - lowers esophageal pressure in critical care patients. (time frame: for 15 minutes after assigned BIS level has been maintained for one hour, while in the ICU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2014.