Clinical trial NCT05272306: Gastro-laryngeal Tube During Transesophageal Echocardiography
Official title: The Utility of Gastro-laryngeal Tube During Transesophageal Echocardiography: Prospective Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Sedation
Analgesia
Airway Complication of Anesthesia
Keywords: Anesthesia
Sedation
Analgesia
Gastro-laryngeal tube
Transesophageal echocardiography
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2022-03-09
Enrollment: 42
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective Randomized Clinical Trial
Primary purpose: SCREENING

Brief summary: To analyze the effects of the use of Gastro-laryngeal Tube on intraoperative and postoperative hemodynamics, procedure comfort, and cardiologist and patient satisfactions during transesophageal echocardiography.

Detailed description: Transesophageal echocardiography (TEE) is an ultrasonic imaging method providing anatomic, functional and hemodynamic information by imaging the heart and thoracic vascular structures using a probe advanced through the esophagus toward the stomach. The probe, with an ultrasonic wave converter at the tip, is placed in the patient's esophagus and begins assessment at the closest location to the heart. This position allows detailed assessment of the heart. It is commonly used during heart surgery, while it is also used in outpatient practice during cardiology examinations for diagnostic purposes.

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.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiology (ASA) physical status I-II
* Aged 20-75 years old

Exclusion Criteria:

* Under 20 years old
* 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.

Primary outcomes:
measure: A questionnaire for cardiologist satisfaction
timeFrame: A questionnaire will be performed to cardiologist 30 minutes after the procedure
Secondary outcomes:
measure: Number of attempts for successful transesophageal echocardiography
timeFrame: Transesophageal echocardiography probe will be inserted during the procedure.
measure: A questionnaire for patient satisfaction
timeFrame: A questionnaire will be performed to the all patients 2 hours after the procedure
measure: Heart rate
timeFrame: From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
measure: Mean arterial pressure
timeFrame: From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
measure: Peripheral oxygen saturation
timeFrame: From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Muhittin Calim
state: Fatih
Study officials:
affiliation: Bezmialem Vakif University
name: Muhittin Calim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.