TEE Techniques for Swallowing Difficulty After Lung Transplant
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of California, Los Angeles
Disqualifiers: Perforated esophagus, esophageal stricture, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The primary outcome of this study is dysphagia (difficulty swallowing) on postoperative speech and swallow evaluation following lung transplantation.
Transesophageal echocardiography (TEE) (creates pictures of the heart from inside the participants body) is routinely performed for all lung transplantations at the University of California, Los Angeles (UCLA) and it is the standard of care. Patients are randomized to two groups. The intervention group would limit the number of TEE clips (# pictures taken) per case. The control group would leave the number of TEE clips to the discretion of the attending anesthesiologist.
The investigators hypothesize that reduction in TEE imaging during lung transplantation will reduce dysphagia.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Transesophageal Echocardiography (TEE) for swallowing difficulty after lung transplant?
Transesophageal echocardiography (TEE) is a widely used technology in critical care and has been shown to be useful in various medical settings, such as assessing heart conditions during surgery. While there is no direct evidence of its effectiveness for swallowing difficulties after lung transplant, its established utility in other complex medical scenarios suggests potential benefits.
12345Is transesophageal echocardiography (TEE) generally safe for humans?
Transesophageal echocardiography (TEE) is generally safe, with most complications being minor, such as nausea or throat irritation. Serious complications are rare, occurring in less than 1% of cases, and include issues like esophageal damage or bleeding.
13678How does the treatment Transesophageal Echocardiography (TEE) for swallowing difficulty after lung transplant differ from other treatments?
Transesophageal Echocardiography (TEE) is unique because it uses an ultrasound probe inserted into the esophagus to create detailed images of the heart, which can help assess swallowing difficulties after lung transplants. Unlike other treatments, TEE provides a direct view of the heart and surrounding structures, potentially offering more precise information for managing swallowing issues.
145910Eligibility Criteria
This trial is for adult patients undergoing single or double lung transplantation at UCLA. It's not suitable for individuals with conditions like a perforated esophagus, narrowed esophagus, esophageal cancer, or those who have had their esophagus removed. Patients needing a tracheostomy after surgery are also excluded.Inclusion Criteria
I am 18 years old or older.
I have had a lung transplant.
Exclusion Criteria
I do not have any conditions that make throat exams unsafe, like a torn esophagus or throat surgery history.
I will need a tracheostomy after surgery.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo lung transplantation with TEE performed, randomized to either limited or standard number of TEE clips
1 day
1 visit (in-person, surgical procedure)
Postoperative Evaluation
Postoperative speech and swallow evaluation performed by a speech/language therapist
1 day
1 visit (in-person, bedside evaluation)
Follow-up
Participants are monitored for dysphagia and other outcomes until discharge from the hospital
5-10 days
Participant Groups
The study tests if limiting the number of TEE (heart imaging from inside the body) clips during lung transplant surgery can reduce swallowing difficulties afterwards. Participants will be randomly assigned to two groups: one with limited TEE clips and another where the attending anesthesiologist decides on the number of clips.
2Treatment groups
Experimental Treatment
Group I: Transesophageal Echocardiography (TEE) with number of TEE clips per attending anesthesiologistExperimental Treatment1 Intervention
The control group would leave the number of TEE clips to the discretion of the attending anesthesiologist.
Group II: Transesophageal Echocardiography (TEE) with limited number of TEE clipsExperimental Treatment1 Intervention
The intervention group would limit the number of TEE clips per case.
Transesophageal Echocardiography (TEE) with limited number of TEE clips is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Transesophageal Echocardiography for:
- Cardiovascular imaging
- Monitoring during surgical procedures
🇪🇺 Approved in European Union as Transesophageal Echocardiography for:
- Cardiovascular imaging
- Monitoring during surgical procedures
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Ronald Reagan UCLA Medical Center, Department of Anesthesiology & Perioperative MedicineLos Angeles, CA
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Who Is Running the Clinical Trial?
University of California, Los AngelesLead Sponsor
References
Use, Training, and Opinions About Effectiveness of Transesophageal Echocardiography in Adult Liver Transplantation Among Anesthesiologists in the United States. [2018]Describe transesophageal echocardiography (TEE) use, preparatory training and opinions about clinical importance, and future training pathways in a sample of liver transplant anesthesiologists.
Overview of transesophageal echocardiography for the chest physician. [2019]Transesophageal echocardiography (TEE) is a growing technology that is frequently utilized in the critical care setting by intensivists, surgeons, anesthesiologists as well as specialists in cardiovascular diseases. The clinical application of TEE continues to emerge, and the indications and diagnostic utility of this technology as currently available are summarized in this review.
Safety and feasibility of transesophageal echocardiography in patients with prior esophageal surgery. [2021]Transesophageal echocardiography (TEE) is a specialized form of cardiac ultrasound and has been associated with rare but serious complications. In patients with prior esophageal surgery, the risk of esophageal damage or the inability to perform a comprehensive and successful TEE warrants further evaluation.
Transesophageal Echocardiography - Dysphagia Risk in Acute Stroke (TEDRAS): a prospective, blind, randomized and controlled clinical trial. [2021]Dysphagia is common in acute stroke and leads to worse overall outcome. Transesophageal echocardiography (TEE) is used in the diagnostic evaluation of stroke with regard to its etiology and is a known cause of postoperative dysphagia in cardiac surgery. The prevalence of dysphagia in acute stroke patients undergoing TEE remains unknown. The aim of the Transesophageal Echocardiography - Dysphagia Risk in Acute Stroke (TEDRAS) study was to assess the influence of TEE on swallowing among patients who have experienced acute stroke.
Transesophageal echocardiography: experience of a Canadian centre. [2008]Transesophageal echocardiography (TEE) is a new application of echocardiography in which an ultrasonic transducer is positioned in the esophagus and stomach to obtain images of the heart without interference from lung and bone. It is particularly useful in the assessment of left atrial masses, atrial septal defects, mitral valve disease, valvular prostheses and aortic dissection. In the operative setting, TEE is used to detect early myocardial ischemia in patients with coronary artery disease undergoing noncardiac surgery as well as in the assessment of the results of valvular surgery. This review examines the technique of TEE, its indications and the early experience with the first 100 patients examined at the Toronto Western Hospital with this technique.
[Failure and complications of transesophageal echocardiography. Apropos of 1500 consecutive cases]. [2016]Transesophageal echocardiography (TEE) requires the introduction of a flexible probe into the oesophagus and therefore cannot be strictly considered to be non-invasive. This manipulation exposes the patient to complications which are benign in the large majority of cases. The authors report their experience in a prospective study analysing the failures and complications of TEE in the first 1,500 cases performed in their laboratory between May 1988 and May 1992, in mainly adult and ambulatory patients. The probe could not be introduced in 24 patients (1.6%), including 5 cases during the initial learning period. No serious complications were observed during of after TEE. Minor incidents were noted in 28 cases (1.9%) intolerance of the probe (12 cases), nausea and/or vomiting (4 cases), dyspnea (4 cases) due to tracheal intubation in 2 patients, laryngeal in 1 patient and to cardiac failure in 1 case. Pharyngeal haemorrhage (2 cases), atrial fibrillation (3 cases), vertigo (1 case), mandibular dislocation (1 case) and salivary hypersecretion affecting the quality of the imaging (1 case), were also observed. The investigation had to be interrupted prematurely in 12 cases (0.8%) usually because of intolerance of the probe. These results show that TEE is not dangerous in trained hands. Failure to introduce the probe is usually encountered during the learning period, which reinforces the need for apprenticeship in a teaching center. The safety of this technique, plus its considerable diagnostic value in many clinical indications, justify its present role in everyday cardiological practice.
Difficult TEE Probe Placement: The Evidence, Troubleshooting Techniques, and a Guide to Alternative Monitoring Options for Intraoperative Physicians. [2020]Transesophageal echocardiography (TEE) imaging has become an essential component of many open and interventional cardiac procedures and has increasing use in monitoring for noncardiac procedures, partly because of an aging population. Whether expected or not, encountering difficulty when inserting the TEE probe presents the anesthesiologist with a conundrum. Repeated insertion attempts increase the risk of a serious complication; however, proceeding without TEE may be unacceptable to the proceduralist or surgeon. The aim of this review is to present the spectrum of complications possible with TEE, propose several evidence-based insertion tips, examine potential alternative cardiac imaging options, and finally, propose a roadmap for providers who encounter difficulty when placing a TEE probe.
Complications of intraoperative transesophageal echocardiography in adult cardiac surgical patients - experience of two institutions in Taiwan. [2016]There is some safety concern about transesophageal echocardiography (TEE) when it is used routinely during cardiac operations. The purpose of this investigation was to study the incidence of intraoperative TEE-associated complications in adult cardiac surgical patients. The study population comprised 6255 consecutive adult cardiac surgical patients with intraoperative TEE examinations. TEE-associated complications occurred in 25 patients (0.4%). Most of these complications consisted of oropharyngeal mucosal bleeding (15/25, 60%). Esophageal perforation occurred in one patient. Two patients experienced upper gastrointestinal bleeding. Seven patients experienced dental injuries, and TEE probe insertion failed in 10 patients. We conclude that intraoperative TEE-associated complications in cardiac operations is very low; the complication rate we found was comparable to previously reported values.
Transesophageal echocardiography and risk of respiratory failure in patients who had ischemic stroke or transient ischemic attack: an IDEAL phase 4 study. [2022]Transesophageal echocardiography (TEE) is sometimes used to search for cardioembolic sources after ischemic stroke or transient ischemic attack (TIA). TEE visualizes some sources better than transthoracic echocardiography, but TEE is invasive and may cause aspiration. Few data exist on the risk of respiratory complications after TEE in patients who had stroke or TIA. Our objective was to determine whether TEE was associated with increased risk of respiratory failure in patients who had ischemic stroke or TIA.
Transesophageal echocardiography: expanding indications for ICU use. How TEE can complement--or surpass--transthoracic techniques. [2016]Transesophageal echocardiography (TEE) is a Doppler technique that uses the esophagus as an acoustic window. In critically ill patients (particularly ventilated patients), TEE may be used to assess left ventricular function, valvular disease, endocarditis, and prosthetic valve dysfunction. It is also helpful in elucidating the cause of hypotension after cardiac surgery, and can detect chronic aortic dissection and transection, valve rupture, and myocardial contusion in trauma victims. TEE is superior to transthoracic echocardiography in evaluating a cardiac source of embolism. Contraindications to TEE include esophageal disorders and an uncorrected bleeding diathesis; a large hiatal hernia may cause suboptimal transgastric images.