Gastro-laryngeal Tube During Transesophageal Echocardiography
Condition: Anesthesia; Sedation; Analgesia; Airway Complication of Anesthesia
Study type: Interventional

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.
    

Intervention name(s): Number of attempts for successful transesophageal echocardiography; A questionnaire for cardiologist satisfaction; A questionnaire for patient satisfaction
Intervention type(s): Other; Diagnostic Test; Diagnostic Test
Intervention description(s): 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 will be measured on a grade of 0-4 (1= very bad, 2= bad, 3= good, 4= very good).; 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 name(s): TEE; Questionnaire; Questionnaire
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective Randomized Clinical Trial
Masking: Single (Participant)
Primary purpose: Screening
Keywords: Anesthesia; Sedation; Analgesia; Gastro-laryngeal tube; Transesophageal echocardiography