AzTrials
AzTrials

AnesthesiaGLTNCT05272306

Gastro-laryngeal Tube During Transesophageal Echocardiography

A study testing Number of attempts for successful transesophageal echocardiography, A questionnaire for cardiologist satisfaction and A questionnaire for patient satisfaction in people with Anesthesia and Sedation, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Anesthesia, Sedation, Analgesia
What is being tested?
Number of attempts for successful transesophageal echocardiography, A questionnaire for cardiologist satisfaction and A questionnaire for patient satisfaction
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteTurkey (Türkiye)
Study dates
13 Apr 2022to 20 Sep 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Muhittin Calim

    Istanbul, Fatih, 34093

Other trials in Turkey (Türkiye)

About this study

Official title: The Utility of Gastro-laryngeal Tube During Transesophageal Echocardiography: Prospective Randomized Clinical Trial

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.

Read the 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.

Being tested
Number of attempts for successful transesophageal echocardiography, A questionnaire for cardiologist satisfaction, A questionnaire for patient satisfaction
Keywords
Anesthesia, Sedation, Analgesia, Gastro-laryngeal tube, Transesophageal echocardiography
Medical subject headings
Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Number of attempts for successful transesophageal echocardiographyOther

    Also called TEE

    Transesophageal echocardiography probe will be inserted after induction of anesthesia. Number of attempts for successful transesophageal echocardiography will be recorded.

  • A questionnaire for cardiologist satisfactionDiagnostic test

    Also called Questionnaire

    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 satisfactionDiagnostic test

    Also called Questionnaire

    A questionnaire for patient satisfaction will be measured on a grade of 0-4 (1= very bad, 2= bad, 3= good, 4= very good).

Study groups in NCT05272306
Study groupRoleWhat they receive
Sedation and AnalgesiaActive comparatorA 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.
Receives: Other: Number of attempts for successful transesophageal echocardiography; Diagnostic Test: A questionnaire for cardiologist satisfaction; Diagnostic Test: A questionnaire for patient satisfaction
Gastro-laryngeal TubeActive comparatorAfter 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.
Receives: Other: Number of attempts for successful transesophageal echocardiography; Diagnostic Test: A questionnaire for cardiologist satisfaction; Diagnostic Test: A questionnaire for patient satisfaction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: A questionnaire will be performed to cardiologist 30 minutes after the procedure

Secondary outcomes (5)
  1. 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.

    Measured: Transesophageal echocardiography probe will be inserted during the procedure.

  2. 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).

    Measured: A questionnaire will be performed to the all patients 2 hours after the procedure

  3. Heart rate

    Heart rate is measured as beats/minute on the anesthesia monitor

    Measured: From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)

  4. Mean arterial pressure

    Mean arterial pressure is measured as mmHg on the anesthesia monitor

    Measured: From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)

  5. Peripheral oxygen saturation

    Peripheral oxygen saturation is measured as percentage (%) on the anesthesia monitor

    Measured: From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2022
  2. Study start13 Apr 2022
  3. Primary completion13 Sep 2022
  4. Study completion20 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective Randomized Clinical Trial
Masking
Single blind
Who is masked
Participant
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05272306
Sponsor's protocol ID
muhittincalim1
Acronym
GLT
Status last verified
Sep 2022
First submitted
28 Feb 2022
Last updated
29 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27210780

Questions about this trial

What is this clinical trial studying?

A study testing Number of attempts for successful transesophageal echocardiography, A questionnaire for cardiologist satisfaction and A questionnaire for patient satisfaction in people with Anesthesia and Sedation, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

A questionnaire for cardiologist satisfaction (time frame: A questionnaire will be performed to cardiologist 30 minutes after the procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05272306, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2022.

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