Image Quality
Conditions
Brief summary
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.
Interventions
DEVICESuctioning orogastric tube which is attached to TEE probe cover
Suctioning orogastric tube which is atttached to TEE probe cover.
Sponsors
Henry Ford Hospital
Henry Ford Health System
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
Since this is a single group study, participant, care provider, and investigator will NOT be masked. However, outcome assessor (who assess image quality and perform measurement using stored TEE images) will be masked
Intervention 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
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Cardiac procedures and liver transplants which had intraoperative TEE -
Exclusion criteria
general contraindication with TEE, apparent complications which are related to TEE. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Image Quality Assessment Method#1: Difference in Likert Scale Before/After Suctioning | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reproducibility of the LV FAC (Inter-observer) | Images were acquired after general anesthesia induction (before suctioning) and after 10minutes (after suctioning images). | 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) |
| Reproducibility of the LV FAC (Intra-observer) | 6-8 months after initial images obtained during surgery. | 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. |
| Reproducibility of the RV FAC (Inter-observer) | Images were acquired after general anesthesia induction (before suctioning) and after 10minutes (after suctioning). | 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. |
| Reproducibility of the RV FAC (Intra-observer) | 6-8 months after initial images obtained during surgery. | 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. |
Countries
United States
Participant flow
Pre-assignment details
3 patients excluded due to resistance to orogastric tube advancement.
Participants by arm
| Arm | Count |
|---|---|
| TEE Image Before and After Suctioning Orogastric Tube 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. | 50 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| TEE Imaging Before Suctioning | Physician Decision | 3 |
Baseline characteristics
| Characteristic | TEE Image Before and After Suctioning Orogastric Tube | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 50 Participants | — |
| Age, Continuous | 61 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 50 participants | — |
| Sex/Gender, Customized gender not known | 50 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
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)
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.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| TEE Image Before and After Suctioning Orogastric Tube | Image Quality Assessment Method#1: Difference in Likert Scale Before/After Suctioning | Improved after suction | 83 images |
| TEE Image Before and After Suctioning Orogastric Tube | Image Quality Assessment Method#1: Difference in Likert Scale Before/After Suctioning | Same after suction | 65 images |
| TEE Image Before and After Suctioning Orogastric Tube | Image Quality Assessment Method#1: Difference in Likert Scale Before/After Suctioning | Worse after suction | 2 images |
Secondary
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)
Time frame: Images were acquired after general anesthesia induction (before suctioning) and after 10minutes (after suctioning images).
Population: Inter-observer intraclass correlation coefficients of LV FAC before and after suctioning.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TEE Image Before and After Suctioning Orogastric Tube | Reproducibility of the LV FAC (Inter-observer) | Intraclass correlation coefficients of LV FAC before suctioning | 0.94 correlation coefficient |
| TEE Image Before and After Suctioning Orogastric Tube | Reproducibility of the LV FAC (Inter-observer) | Intraclass correlation coefficients of LV FAC after suctioning | 0.99 correlation coefficient |
Secondary
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.
Time frame: 6-8 months after initial images obtained during surgery.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TEE Image Before and After Suctioning Orogastric Tube | Reproducibility of the LV FAC (Intra-observer) | Intraclass correlation coefficients of LV FAC before suctioning | 0.95 correlation coefficient |
| TEE Image Before and After Suctioning Orogastric Tube | Reproducibility of the LV FAC (Intra-observer) | Intraclass correlation coefficients of LV FAC after suctioning | 1.00 correlation coefficient |
Secondary
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.
Time frame: Images were acquired after general anesthesia induction (before suctioning) and after 10minutes (after suctioning).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TEE Image Before and After Suctioning Orogastric Tube | Reproducibility of the RV FAC (Inter-observer) | Intraclass correlation coefficients of RV FAC before suctioning | 0.89 correlation coefficient |
| TEE Image Before and After Suctioning Orogastric Tube | Reproducibility of the RV FAC (Inter-observer) | Intraclass correlation coefficients of RV FAC after suctioning | 0.90 correlation coefficient |
Secondary
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.
Time frame: 6-8 months after initial images obtained during surgery.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TEE Image Before and After Suctioning Orogastric Tube | Reproducibility of the RV FAC (Intra-observer) | Intraclass correlation coefficients of RV FAC before suctioning | 0.88 correlation coefficient |
| TEE Image Before and After Suctioning Orogastric Tube | Reproducibility of the RV FAC (Intra-observer) | Intraclass correlation coefficients of RV FAC after suctioning | 0.85 correlation coefficient |