Image QualityNCT03812185
TEE Image Quality Improvement With Our Devised Probe Cover
A study testing Suctioning orogastric tube which is attached to TEE probe cover in people with Image Quality, run by Henry Ford Health System at 1 site in United States.
Trial summary
With using suction tube attached TEE probe cover, we will assess its pinpoint suction capacity on image quality and surgical decision making. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Image Quality
- What is being tested?
- Suctioning orogastric tube which is attached to TEE probe cover
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2019to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Inclusion Criteria: Cardiac procedures and liver transplants which had intraoperative TEE -
Exclusion Criteria: general contraindication with TEE, apparent complications which are related to TEE.
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TEE Image Quality Improvement With Our Devised Transesophageal Echocardiography Probe Cover and Its Effect on Surgical Decision Making
With using suction tube attached TEE probe cover, we will assess its pinpoint suction capacity on image quality and surgical decision making.
Read the detailed description
Background: Transesophageal echocardiography (TEE) has become a standard intraoperative diagnosis technique for clinical management of patients during cardiac and non-cardiac surgery. Accurate intraoperative diagnosis by TEE improves as image quality improves. Although we recently reported enhanced image quality using a TEE probe with an attached orogastric tube, its clinical significance is still unknown. Also, we are concerned about potential clinical complications including damage to the upper gastrointestinal tract due to its rough surface. Therefore, we devised a new TEE probe cover equipped with a suction catheter and ultrasound gel containing pad that functions as a cushion for preventing surrounding tissue trauma. Our long-term goal is to improve TEE image quality, which will help surgical decision-making with precise assessment. The study population will be elective cardiac cases and liver transplant cases at Henry Ford Hospital. The objective of this grant is to assess the image quality change with our newly designed TEE probe, and its clinical utility on patient care in different types of procedures.
Aim 1. To assess TEE image quality before and after pin-point suctioning with our newly designed TEE probe. We hypothesize that decreasing stomach air between the TEE probe transducer and tissue wall by pin-point suction with our newly designed TEE probe will reduce ultrasound reflection and lead to better image quality.
Aim 2. To evaluate the clinical utility of our newly designed TEE probe cover. We hypothesize our newly designed TEE probe cover will facilitate decision-making for both anesthesiologists and surgeons and it will not increase the occurrence of TEE probe related trauma.
- Conditions
- Image Quality
- Being tested
- Suctioning orogastric tube which is attached to TEE probe cover
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suctioning orogastric tube which is attached to TEE probe coverDevice
Suctioning orogastric tube which is atttached to TEE probe cover.
| Study group | Role | What they receive |
|---|---|---|
| TEE image before and after suctioning orogastric tube | Other | for intraoperative TEE used cardiac or transplant cases, TEE images will be stored before and after suctioning orogastric tube which is attached to TEE probe cover. This Arm is TEE image BEFORE suctioning. Receives: Device: Suctioning orogastric tube which is attached to TEE probe cover |
What is being measured
The primary outcome is the main question the study is designed to answer.
Image Quality Assessment Method#1: Difference in Likert Scale Before/After Suctioning
Difference in image quality assessment by Likert scale before/after suctioning, by assessing quality of images stored before/after suctioning. Investigators categorized the quality of all acquired images on a numeric scale (the higher number means higher image quality) based on each investigator's impression (1: very poor, 2: poor, 3: acceptable, 4: good, and 5: very good). Image quality improvement was determined by increased number. Three investigators (A, B, C) assessed the quality of all TEE image sets (i.e. before and after suctioning) post hoc. The acquired numeric scales were combined, and compared before and after suctioning, and calculated how much percentage of patients had improved image quality (i.e. increase in numeric scale), same quality (i.e. same numeric scale), and worsened image quality (i.e. decrease in numeric scale)
Measured: TEE image sets were acquired after general anesthesia induction (before suctioning) and after 10minutes (after suctioning), and the outcome was the difference in image quality. In 6-8 months, investigator C did the same analysis on the same images.
Secondary outcomes (4)
Reproducibility of the LV FAC (Inter-observer)
The reproducibility of the LV FAC was assessed, assuming that better image quality would yield better LV FAC reproducibility. Three investigators (A, B, and C) assessed the quality of all TEE image sets (i.e. before and after suctioning) post hoc. These image sets are combined and assessment was done for each group (i.e. before and after suctioning)
Measured: Images were acquired after general anesthesia induction (before suctioning) and after 10minutes (after suctioning images).
Reproducibility of the LV FAC (Intra-observer)
Investigator C analyzed all image sets again in 6-8 months to determine if there was intra-observer variability with the initial assessment of image quality. All investigators were blinded to which images were obtained before or after suctioning.
Measured: 6-8 months after initial images obtained during surgery.
Reproducibility of the RV FAC (Inter-observer)
The reproducibility of the RV FAC was assessed, assuming that better image quality would yield better RV FAC reproducibility. Three investigators (A, B, and C) assessed the quality of all TEE image sets (i.e. before and after suctioning) post hoc.
Measured: Images were acquired after general anesthesia induction (before suctioning) and after 10minutes (after suctioning).
Reproducibility of the RV FAC (Intra-observer)
Investigator C analyzed all image sets again in 6-8 months to determine if there was intra-observer variability with the initial assessment of image quality. All investigators were blinded to which images were obtained before or after suctioning.
Measured: 6-8 months after initial images obtained during surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start1 Jan 2019
- Primary completion14 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Image QualityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- For intraoperative TEE used cardiac or transplant cases, investigators will compare TEE image quality before and after suctioning using orogastric tube attached TEE probe cover
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Henry Ford Hospital
- Responsible party
- Principal investigator, Yoshihisa Morita, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03812185
- Sponsor's protocol ID
- 11958
- Status last verified
- Nov 2023
- First submitted
- 18 Jan 2019
- Last updated
- 13 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TEE Image Quality Improvement With Our Devised Transesophageal Echocardiography Probe Cover and Its Effect on Surgical Decision Making
- ClinicalTrials.gov ID
- NCT03812185
- Acronym / sponsor ID
- 11958
- Conditions
- Image Quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Collaborators
- Henry Ford Hospital
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 14 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 23 Jan 2019 (actual)
- Results
- Posted 13 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
With using suction tube attached TEE probe cover, we will assess its pinpoint suction capacity on image quality and surgical decision making.
Detailed description
Background: Transesophageal echocardiography (TEE) has become a standard intraoperative diagnosis technique for clinical management of patients during cardiac and non-cardiac surgery. Accurate intraoperative diagnosis by TEE improves as image quality improves. Although we recently reported enhanced image quality using a TEE probe with an attached orogastric tube, its clinical significance is still unknown. Also, we are concerned about potential clinical complications including damage to the upper gastrointestinal tract due to its rough surface. Therefore, we devised a new TEE probe cover equipped with a suction catheter and ultrasound gel containing pad that functions as a cushion for preventing surrounding tissue trauma. Our long-term goal is to improve TEE image quality, which will help surgical decision-making with precise assessment. The study population will be elective cardiac cases and liver transplant cases at Henry Ford Hospital. The objective of this grant is to assess the image quality change with our newly designed TEE probe, and its clinical utility on patient care in different types of procedures.
Aim 1. To assess TEE image quality before and after pin-point suctioning with our newly designed TEE probe. We hypothesize that decreasing stomach air between the TEE probe transducer and tissue wall by pin-point suction with our newly designed TEE probe will reduce ultrasound reflection and lead to better image quality.
Aim 2. To evaluate the clinical utility of our newly designed TEE probe cover. We hypothesize our newly designed TEE probe cover will facilitate decision-making for both anesthesiologists and surgeons and it will not increase the occurrence of TEE probe related trauma.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- For intraoperative TEE used cardiac or transplant cases, investigators will compare TEE image quality before and after suctioning using orogastric tube attached TEE probe cover
| Arm | Type | Receives |
|---|---|---|
| TEE image before and after suctioning orogastric tube | Other | Device: Suctioning orogastric tube which is attached to TEE probe coverfor intraoperative TEE used cardiac or transplant cases, TEE images will be stored before and after suctioning orogastric tube which is attached to TEE probe cover. This Arm is TEE image BEFORE suctioning. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Suctioning orogastric tube which is attached to TEE probe coverSuctioning orogastric tube which is atttached to TEE probe cover. | Device | TEE image before and after suctioning orogastric tube |
Primary outcome
Image Quality Assessment Method#1: Difference in Likert Scale Before/After Suctioning
Time frame: TEE image sets were acquired after general anesthesia induction (before suctioning) and after 10minutes (after suctioning), and the outcome was the difference in image quality. In 6-8 months, investigator C did the same analysis on the same images.
Difference in image quality assessment by Likert scale before/after suctioning, by assessing quality of images stored before/after suctioning. Investigators categorized the quality of all acquired images on a numeric scale (the higher number means higher image quality) based on each investigator's impression (1: very poor, 2: poor, 3: acceptable, 4: good, and 5: very good). Image quality improvement was determined by increased number. Three investigators (A, B, C) assessed the quality of all TEE image sets (i.e. before and after suctioning) post hoc. The acquired numeric scales were combined, and compared before and after suctioning, and calculated how much percentage of patients had improved image quality (i.e. increase in numeric scale), same quality (i.e. same numeric scale), and worsened image quality (i.e. decrease in numeric scale)
4 secondary outcomes
Reproducibility of the LV FAC (Inter-observer)
Time frame: Images were acquired after general anesthesia induction (before suctioning) and after 10minutes (after suctioning images).
Reproducibility of the LV FAC (Intra-observer)
Time frame: 6-8 months after initial images obtained during surgery.
Reproducibility of the RV FAC (Inter-observer)
Time frame: Images were acquired after general anesthesia induction (before suctioning) and after 10minutes (after suctioning).
Reproducibility of the RV FAC (Intra-observer)
Time frame: 6-8 months after initial images obtained during surgery.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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?
A study testing Suctioning orogastric tube which is attached to TEE probe cover in people with Image Quality, run by Henry Ford Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2023. 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?
Yes. Results are posted in the registry (first posted 13 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Image Quality Assessment Method#1: Difference in Likert Scale Before/After Suctioning (time frame: TEE image sets were acquired after general anesthesia induction (before suctioning) and after 10minutes (after suctioning), and the outcome was the difference in image quality. In 6-8 months, investigator C did the same analysis on the same images.). 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 13 Dec 2023.