An interventional study of Suctioning orogastric tube which is attached to TEE probe cover in Image Quality, sponsored by Henry Ford Health System. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2023-12-13.
Sponsored by Henry Ford Health System · Not applicable, Interventional, and Diagnostic
With using suction tube attached TEE probe cover, we will assess its pinpoint suction capacity on image quality and surgical decision making.
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.
Henry Ford Health System is the lead sponsor of 303 studies on the registry; 50 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 24 (65%) have results posted.
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Inclusion Criteria: Cardiac procedures and liver transplants which had intraoperative TEE -
Exclusion Criteria: general contraindication with TEE, apparent complications which are related to TEE.
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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.
Device: Suctioning orogastric tube which is attached to TEE probe cover
Suctioning orogastric tube which is atttached to TEE probe cover.
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.
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).
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.
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).
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.
| Milestone | TEE Image Before and After Suctioning Orogastric Tube |
|---|---|
| Started | 53 |
| Completed | 50 |
| Not completed | 3 |
| Withdrew: Physician decision | 3 |
| Milestone | TEE Image Before and After Suctioning Orogastric Tube |
|---|---|
| Started | 50 |
| Completed | 50 |
| Not completed | 0 |
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)
| images | TEE Image Before and After Suctioning Orogastric Tube |
|---|---|
| Improved after suction | 83 |
| Same after suction | 65 |
| Worse after suction | 2 |
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)
| correlation coefficient | TEE Image Before and After Suctioning Orogastric Tube |
|---|---|
| Intraclass correlation coefficients of LV FAC before suctioning | 0.94 (0.91 to 0.96) |
| Intraclass correlation coefficients of LV FAC after suctioning | 0.99 (0.98 to 0.99) |
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.
| correlation coefficient | Difference in TEE Imaging Before/After Suctioning at 6 Months After the Surgery |
|---|---|
| Intraclass correlation coefficients of LV FAC before suctioning | 0.95 (0.91 to 0.99) |
| Intraclass correlation coefficients of LV FAC after suctioning | 1.00 (0.99 to 1.00) |
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.
| correlation coefficient | Difference in TEE Imaging Before/After Suctioning at 6 Months After the Surgery |
|---|---|
| Intraclass correlation coefficients of RV FAC before suctioning | 0.89 (0.84 to 0.92) |
| Intraclass correlation coefficients of RV FAC after suctioning | 0.90 (0.86 to 0.94) |
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.
| correlation coefficient | Difference in TEE Imaging Before/After Suctioning at 6 Months After the Surgery |
|---|---|
| Intraclass correlation coefficients of RV FAC before suctioning | 0.88 (0.81 to 0.92) |
| Intraclass correlation coefficients of RV FAC after suctioning | 0.85 (0.84 to 0.9) |
Collected over 1month. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| TEE Image Before Suctioning Orogastric Tube | 0/50 (0%) | 0/50 (0%) | 0/50 (0%) |
| TEE Image After Suctioning Orogastric Tube | 0/50 (0%) | 0/50 (0%) | 0/50 (0%) |
| Age, Categorical(Participants) | TEE Image Before and After Suctioning Orogastric Tube |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 50 |
| >=65 years | 0 |
| Age, Continuous(years) | TEE Image Before and After Suctioning Orogastric Tube |
|---|---|
| Least squares mean | 61 (48 to 68) |
| Sex/Gender, Customized(Participants) | TEE Image Before and After Suctioning Orogastric Tube |
|---|---|
| gender not known | 50 |
| Race and Ethnicity Not Collected(Participants) | TEE Image Before and After Suctioning Orogastric Tube |
|---|
| Region of Enrollment(participants) | TEE Image Before and After Suctioning Orogastric Tube |
|---|---|
| United States | 50 |
Documents are hosted by the registry — open the source record to download them.
Ran from Jan 2019 to primary completion in Dec 2019, 11 months.
Results were first posted in Dec 2023, 3 years 11 months after primary completion.
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