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Image quality of intraoperative transesophageal echocardiography (TEE) tends to get worse during long hours of operations. An orogastric tube (OGT) is often inserted in the beginning of the case, and left there for intermittent suction as needed, or removed before TEE exam to prevent echoic artifacts. However, if left there, the effect of suction might be limited due to unreliable tip position of the OG tube. If removed, stomach will be distended again. We devised the OG tube attached TEE for practical suction and assessed its effect on image quality intraoperatively.
OGT attached TEE probe is used for cardiac and liver transplantation cases. Each case is assigned 3 investigators who are blinded to this study design, We do image quality assessment by two methods; firstly, we categorize image quality as numbers based on each investigator's impression (1: Very bad, 2: bad, 3: acceptable, 4: good, 5: very good) and compare the difference in number before and after suctioning. Secondly, we evaluate consistency intraclass correlation coefficient (ICC) for inter-observer variability using investigator A, B and C. We evaluate absolute-agreement ICC for intra-observer variability using investigator C, who perform analysis for all images twice with a 6 to 8 months interval. This analysis was performed with left ventricular fraction area change using transgastric left ventricular short axis view.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEE image before suction | No Intervention | Suction orogastric tube which is attached to TEE probe | |
| TEE image after suction | Experimental | Suction orogastric tube which is attached to TEE probe |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suction orogastric tube which is attached to TEE probe | Procedure | Suction orogastric tube which is attached to TEE probe |
|
| Measure | Description | Time Frame |
|---|---|---|
| Image Quality Assessment Method#1: Difference in Likert Scale Before and 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) | TEE image sets were acquired after general anesthesia induction (before suction) and after 10minutes (after suction), and the outcome was the difference in image quality. In 6-8 months, investigator C did the same analysis on the same images in one day. |
| Measure | Description | Time Frame |
|---|---|---|
| Reproducibility of the Left Ventricular Fraction Area Change (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 tall TEE image sets (i.e. before and after suction) post oc. These image sets were combined, and assessment was done for each group (i.e. before and after suctioning) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Donald Penning, MD | HFHS | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HFHS | Detroit | Michigan | 48202 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | TEE Image Before and After Suctioning Orogastric Tube | For intraoperative TEE used cardiac or liver transplant cases. TEE images will be stored before and after suctioning orogastric tube which is attached to TEE probe |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| TEE Image Before Suction |
| |||||||||||||
| TEE Image After Suction |
|
Surgeries which need intraoperative TEE
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| ID | Title | Description |
|---|---|---|
| BG000 | TEE Image Before and After Suction | Surgeries which need intraoperative TEE (i.e. cardiac surgery and orthotopic liver transplant) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Image Quality Assessment Method#1: Difference in Likert Scale Before and 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) | Surgeries which need intraoperative TEE (cardiac or liver transplant surgery) | Posted | Count of Units | image sets | TEE image sets were acquired after general anesthesia induction (before suction) and after 10minutes (after suction), and the outcome was the difference in image quality. In 6-8 months, investigator C did the same analysis on the same images in one day. | image sets | image sets |
1 month
Esophageal trauma, stomach trauma, GI bleed, dysphagia, or anything related to TEE
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TEE Related Complications | Esophageal trauma, stomach trauma, GI bleed, dysphagia |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yoshihisa Morita | Henry Ford Hospital | 3059784358 | YOSHIHISA.MORITA@JEFFERSON.EDU |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 10, 2017 | Oct 21, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 10, 2017 | Oct 20, 2023 | ICF_001.pdf |
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| Images are acquired after general anesthesia induction (before suctioning) and after 10min (after suctioning) |
| Reproducibility of the Left Ventricular Fraction Area Change (LV FAC) (Intra-observer) | Investigator C assess all the image sets in one day again after 6-8 months to determine if there is intra-observer variability with the initial assessment of image quality, All investigators are blinded to which images are obtained before or after suction | 6-8 months after initial images obtained during surgery |
| Participants |
|
| Age, Continuous | Median | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | TEE Image Before and After Suction | Suction orogastric tube which is attached to TEE probe |
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| Secondary | Reproducibility of the Left Ventricular Fraction Area Change (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 tall TEE image sets (i.e. before and after suction) post oc. These image sets were combined, and assessment was done for each group (i.e. before and after suctioning) | Patients who need intraop TEE for cardiac surgery and liver transplant surgery) | Posted | Number | 95% Confidence Interval | intraclass correlation coefficient | Images are acquired after general anesthesia induction (before suctioning) and after 10min (after suctioning) | image sets | image sets |
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| Secondary | Reproducibility of the Left Ventricular Fraction Area Change (LV FAC) (Intra-observer) | Investigator C assess all the image sets in one day again after 6-8 months to determine if there is intra-observer variability with the initial assessment of image quality, All investigators are blinded to which images are obtained before or after suction | Patients who need intraop TEE for cardiac surgery and liver transplant surgery) | Posted | Number | 95% Confidence Interval | intraclass correlation coefficient | 6-8 months after initial images obtained during surgery | image sets | image sets |
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