SurgeryNCT03962036
Effect of One-lung Ventilation on BIS Values
An observational study of Surgery and Thoracic, run by Christopher McKee at 1 site in United States.
Trial summary
In this observational study, all enrolled patients having a thoracic surgical procedure requiring lung isolation will have a bispectral index (BIS) monitor placed at time of induction. BIS monitors are used to assist in determining depth of anesthesia. Read more about this study
- Who is it for?
- Any age
- What is being tested?
- Bispectral index monitor
- Type of treatment
- Medical device
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2019to 3 Dec 2021
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Surgical patients requiring one lung ventilation at Nationwide Children's Hospital.
Who may be able to join
- Patients coming for thoracic surgery with anticipated need for lung isolation
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
In this observational study, all enrolled patients having a thoracic surgical procedure requiring lung isolation will have a bispectral index (BIS) monitor placed at time of induction. BIS monitors are used to assist in determining depth of anesthesia. This study will evaluate changes in BIS before, during and after lung isolation.
- Being tested
- Bispectral index monitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bispectral index monitorDevice
Also called BIS
BIS monitor is a novel measure of the level of consciousness by algorithmic analysis of a patient's electroencephalogram during general anesthesia.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BIS
Comparing the BIS readings while on two lung ventilation to the BIS readings after switching the one lung ventilation.
Measured: From baseline to one lung ventilation (average time frame of 30 mins. - 1 hr.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study start11 Oct 2019
- Primary completion3 Dec 2021
- Study completion3 Dec 2021
Why it stopped: Study showed no results
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christopher McKee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christopher McKee, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03962036
- Sponsor's protocol ID
- STUDY00000324
- Status last verified
- Dec 2021
- First submitted
- 22 May 2019
- Last updated
- 20 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of One-lung Ventilation on BIS Values
- ClinicalTrials.gov ID
- NCT03962036
- Acronym / sponsor ID
- STUDY00000324
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study showed no results
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Christopher McKeeUniversity, hospital or other
- Study start
- 11 Oct 2019 (actual)
- Primary completion
- 3 Dec 2021 (actual)
- Study completion
- 3 Dec 2021 (actual)
- First posted
- 23 May 2019 (actual)
- 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.
In this observational study, all enrolled patients having a thoracic surgical procedure requiring lung isolation will have a bispectral index (BIS) monitor placed at time of induction. BIS monitors are used to assist in determining depth of anesthesia. This study will evaluate changes in BIS before, during and after lung isolation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Surgical patients requiring one lung ventilation at Nationwide Children's Hospital.
Key inclusion criteria (1 listed)
- Patients coming for thoracic surgery with anticipated need for lung isolation
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Bispectral index monitorAlso: BISBIS monitor is a novel measure of the level of consciousness by algorithmic analysis of a patient's electroencephalogram during general anesthesia. | Device | – |
Primary outcome
Change in BIS
Time frame: From baseline to one lung ventilation (average time frame of 30 mins. - 1 hr.)
Comparing the BIS readings while on two lung ventilation to the BIS readings after switching the one lung ventilation.
Results and safety
The study was stopped early (reason given: Study showed no results). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery and Thoracic, run by Christopher McKee 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 1 inclusion and 1 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 20 Dec 2021. 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: Study showed no results). 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?
Change in BIS (time frame: From baseline to one lung ventilation (average time frame of 30 mins. - 1 hr.)). 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 20 Dec 2021.