Perioperative Rescue Transesophageal Echocardiography in Intensive and Critical Status

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05960552
Collaborator
(none)
46
1
2
33
1.4

Study Details

Study Description

Brief Summary

We initiated this study to assess the success rate of PReTEE in identifying potential causes of difficult separation from cardiopulmonary bypass among high-risk patients who undergo cardiac surgical procedures.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: The PReTEE group
  • Diagnostic Test: The conventional TEE group
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
46 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Diagnostic
Official Title:
Establishment and Verification of Clinical Thinking Flowchart of Rescue Transesophageal Echocardiography in the Diagnosis and Treatment of Perioperative Patients in Intensive and Critical Status
Actual Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Oct 31, 2025
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: The PReTEE group

Prior to clinical application of PReTEE, all participants designated must receive professional training. Within the given 120 seconds participants in the PreTEE group need to provide the most probable cause with regard to difficult separation from cardiopulmonary bypass among high-risk cardiac surgical procedures.

Diagnostic Test: The PReTEE group
Prior to clinical application of PReTEE, all participants designated must receive professional training. They need to receive lectures focusing on the clinical thinking flowchart of rescue transesophageal echocardiography, in conjuntion with the simulator-based training. The effects of PReTEE will be further assessed in real clinical scenario, that is, within the given 120 seconds participants in the PreTEE group need to provide the most probable cause with regard to difficult separation from cardiopulmonary bypass in high-risk cardiac surgical procedures. All examinations will be supervised by a TEE expert owning to safety considerations but without help in views acquirement or interpretation. After completion of study assessments, the TEE expert will perform a standard comprehensive TEE, the results of which was reported to the attending cardiac anesthesiologist in charge of the patient and recorders.

Active Comparator: The conventional TEE group

The routine intra-operative TEE examinations were performed within the given 120 seconds before patients were separated from the cardiopulmonary bypass.

Diagnostic Test: The conventional TEE group
Before the separation from cardiopulmonary bypass, routine intraoperative TEE examinations were performed within the given 120 seconds. Then, the expert will perform a standard comprehensive TEE; the most likely reason of difficult separation from cardiopulmonary bypass should be reported to the attending anesthesiologist and recorders.

Outcome Measures

Primary Outcome Measures

  1. Time taken in seconds in seeking out the leading cause of difficult CPB separation. [From the time of appearance of midesophageal 4 chamber view until the time of discrimination of the leading cause of difficult separation from cardiopulmonary bypass by the TEE operator, assessed up to 120 seconds.]

    Time will be recorded in rea-time fashion from the appearance of midesophageal 4 chamber view to the diagnose of leading cause of difficult CPB separation in both the PReTEE group and the conventional group.

  2. The rate of successful diagnosis. [From the time of appearance of midesophageal 4 chamber view until the time of discrimination of the leading cause of difficult separation from cardiopulmonary bypass by the TEE operator, assessed up to 120 seconds.]

    Following the completion of TEE assessment by operators in the PreTEE group or in the conventional TEE group, the TEE expert in our center will then perform a standard comprehensive examination. The TEE expert will also be required to provide the leading cause of difficult separation, which then be presented to the attending anesthesiologist and cardiac surgeons as the reference of therapeutic approaches. The successful diagnosis is defined as the agreement of cause between operators in the PreTEE group or in the conventional TEE group and the expert.

Secondary Outcome Measures

  1. The incidence of hypovolemia [From the time of appearance of midesophageal 4 chamber view until the time of discrimination of the leading cause of difficult separation from cardiopulmonary bypass by the TEE operator, assessed up to 120 seconds.]

    Reduction in the LV cavity indicates hypovolemia.

  2. The incidence of obstruction [From the time of appearance of midesophageal 4 chamber view until the time of discrimination of the leading cause of difficult separation from cardiopulmonary bypass by the TEE operator, assessed up to 120 seconds.]

    The occurrence of SAM or pulmonary embolism

  3. The incidence of regional wall motion abnormality [From the time of appearance of midesophageal 4 chamber view until the time of discrimination of the leading cause of difficult separation from cardiopulmonary bypass by the TEE operator, assessed up to 120 seconds.]

    Regional wall motion is commonly classified as 1) normal or hyperkinetic, 2) hypokinetic (reduced thickening), 3) akinetic (absence of thickening), and 4) dyskinetic (systolic thinning or aneurysmal changes

  4. The incidence of left heart failure [From the time of appearance of midesophageal 4 chamber view until the time of discrimination of the leading cause of difficult separation from cardiopulmonary bypass by the TEE operator, assessed up to 120 seconds.]

    Left heart failure can be assessed as a reduction in systolic function and an increase in diastolic dimension.

  5. The incidence of right heart failure [From the time of appearance of midesophageal 4 chamber view until the time of discrimination of the leading cause of difficult separation from cardiopulmonary bypass by the TEE operator, assessed up to 120 seconds.]

    A TEE with a D-shaped LV on trans-gastric short axis view is suggestive of RV volume overload and failure

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Age of 18 yr and greater;

  2. High-risk cardiac surgery (one of the followings): Baseline left ventricular ejection fraction < 50%, Coronary artery bypass graft combined with valve procedures, Multiple valve procedures (≥ 2), Aortic root or arch involved, Euroscore > 6, Previous cardiovascular surgery

Exclusion Criteria:
  1. Lack of patient consent;

  2. Esophageal pathology (stricture, tumor, perforation/laceration, ulcer or fistula, diverticulum);

  3. Hiatus hernia; Perforated viscus;

  4. Active/recent upper gastrointestinal (GI) bleed;

  5. Non-elective cardiac procedures;

  6. Preoperative mechanical cardiac support (ECMO, LVAD or IABP)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peking Union Medical College Hospital Beijing China

Sponsors and Collaborators

  • Peking Union Medical College Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT05960552
Other Study ID Numbers:
  • K3052
First Posted:
Jul 25, 2023
Last Update Posted:
Jul 25, 2023
Last Verified:
Jul 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Peking Union Medical College Hospital

Study Results

No Results Posted as of Jul 25, 2023