Gastro-laryngeal Tube During Transesophageal Echocardiography
NCT ID: NCT05272306
Last Updated: 2022-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
42 participants
INTERVENTIONAL
2022-04-13
2022-09-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Effect of Sedation During Transesophageal Echocardiography on Heart Rate Variability
NCT01444976
Use of McGrath Videolaryngoscope to Assist Transesophageal Echocardiography Probe Insertion in Intubated Patients
NCT02634047
Evaluation of Regional Myocardial Dynamics at Physical Stress in Essential Hypertension
NCT01442116
The Diagnosis and Treatment System of Transesophageal Echocardiography in ICU
NCT03811730
Comparing Cardiac Chamber Measurements: TTE vs. TEE Under Anesthesia
NCT06715371
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Currently, TEE is performed with the outpatient admission concept in procedure rooms of the relevant departments as a semi-invasive procedure. TEE provides relatively higher quality and detailed assessments compared to transthoracic echocardiography (TTE). When images obtained with TEE are compared with TTE images, posterior structures like the interatrial septum, mitral valve, left atrium and pulmonary veins were reported to be assessed at superior levels. In addition to this advantage of TEE, the presence of the TEE probe in the oropharyngeal passage and need for deep sedation involve high complication risks. During sedation administration, the common use of the oropharyngeal passage by both cardiologist and anesthesiologist forms a risk in terms of airway management. Especially during deep sedation and analgesia, special equipment and manipulation may be required for the safety of airway management.
In modern medical approaches, priority has begun to be given to procedure comfort, along with diagnosis and treatment of the patient. With this aim, endoscopic esophagus procedures are frequently performed under sedation. Sedation administration is not an innocent procedure, and management includes many difficulties. The incidence of complications related anesthesia and the procedure is variable, but hypoxia, unplanned endotracheal intubation secondary to desaturation or aspiration, accidental tracheal insertion of gastroscope, bronchospasm, laryngospasm and hemodynamic instability may be encountered. A review of the literature stated the hypoxia incidence related to sedation was 1.5-70%. The broad interval of incidence is stated to be linked to the use, or not, of airway protective approaches.
The importance given to patient comfort and satisfaction and desire of endoscopist to perform procedures more reliably and with shared responsibility have opened the door to new research and innovations. This demand has motivated industry to develop new pharmaceutical agents and medical instruments. The gastro-laryngeal tube (GLT) is designed with the aim of ensuring the safety of airway management and optimum performance of endoscopy for esophageal procedures under deep sedation and is a new tool offered for use. GLT is a modification of a laryngeal tube allowing passage of the gastroscope or TEE probe, a suitable channel for manipulation and ensuring supraglottic airway control at the same time. There are two inflatable cuffs, one within the esophagus and the other in the hypopharynx. These cuffs ensure airway safety and stabilization of the gastro-laryngeal tube.
The investigators hypothesized that GLT, allowing passage of the TEE probe and ensuring supraglottic airway control, would provide more advantages in terms of hemodynamic stabilization, complications related airway management, cardiologist and patient satisfactions when used in a clinical setting. To date, there has been no detailed prospective clinical study analyzing the performance of the GLT during TEE. The present study sought to address this gap by performing a prospective clinical study to analyze the performance of the GLT during TEE. Primary outcome measures were safety of airway management, and cardiologist and patient satisfactions. This study also recorded demographic characteristics, intraoperative and postoperative hemodynamics, level of hypoxemia, and duration of procedure as secondary outcome measures.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SCREENING
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Sedation and Analgesia
A standardized sedation and analgesia will be administered by an experienced anesthesiologist. After administration of lidocaine and atropine sulfate, and also preoxygenation (100% 4 L/min oxygen for 3 minutes), patients will be induced with propofol and fentanyl via intravenous route at doses calculated according to ideal body weight. Anesthesia was maintained with propofol infusion. Repetitive intravenous boluses of propofol will be administered, if required. Patients will be received oxygen (100%, 3 L/min) through a nasal cannula during sedation and analgesia.
Number of attempts for successful transesophageal echocardiography
Transesophageal echocardiography probe will be inserted after induction of anesthesia. Number of attempts for successful transesophageal echocardiography will be recorded.
A questionnaire for cardiologist satisfaction
A questionnaire for cardiologist satisfaction will be measured on a grade of 0-4 (1= very bad, 2= bad, 3= good, 4= very good).
A questionnaire for patient satisfaction
A questionnaire for patient satisfaction will be measured on a grade of 0-4 (1= very bad, 2= bad, 3= good, 4= very good).
Gastro-laryngeal Tube
After administration of lidocaine and atropine sulfate, and also preoxygenation (100% 4 L/min oxygen for 3 min), patients will be induced with propofol and fentanyl. After induction of anesthesia, supraglottic airway device named Gastro-laryngeal Tube (GLT) will be inserted. Patients will be ventilated mechanically with a tidal volume of 6-8 mL/kg based on ideal body weight and a frequency of 12-14 breaths/min after inserting the GLT. Repetitive intravenous boluses of propofol will be administered, if required.
Number of attempts for successful transesophageal echocardiography
Transesophageal echocardiography probe will be inserted after induction of anesthesia. Number of attempts for successful transesophageal echocardiography will be recorded.
A questionnaire for cardiologist satisfaction
A questionnaire for cardiologist satisfaction will be measured on a grade of 0-4 (1= very bad, 2= bad, 3= good, 4= very good).
A questionnaire for patient satisfaction
A questionnaire for patient satisfaction will be measured on a grade of 0-4 (1= very bad, 2= bad, 3= good, 4= very good).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Number of attempts for successful transesophageal echocardiography
Transesophageal echocardiography probe will be inserted after induction of anesthesia. Number of attempts for successful transesophageal echocardiography will be recorded.
A questionnaire for cardiologist satisfaction
A questionnaire for cardiologist satisfaction will be measured on a grade of 0-4 (1= very bad, 2= bad, 3= good, 4= very good).
A questionnaire for patient satisfaction
A questionnaire for patient satisfaction will be measured on a grade of 0-4 (1= very bad, 2= bad, 3= good, 4= very good).
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Aged 20-75 years old
Exclusion Criteria
* Over 75 years old
* An allergy to anesthetic drugs
* Emergent procedure
* Uncontrolled cerebrovascular disease
* Drug and alcohol addiction
* Performed oropharyngeal surgery
* Patients who refused written informed consent.
20 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bezmialem Vakif University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Muhittin Calim
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Muhittin Calim, MD
Role: PRINCIPAL_INVESTIGATOR
Bezmialem Vakif University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Muhittin Calim
Istanbul, Fatih, Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Daskaya H, Uysal H, Ciftci T, Baysal B, Idin K, Karaaslan K. Use of the gastro-laryngeal tube in endoscopic retrograde cholangiopancreatography cases under sedation/analgesia. Turk J Gastroenterol. 2016 May;27(3):246-51. doi: 10.5152/tjg.2016.16121.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
muhittincalim1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.