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).
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.
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.
- Conditions
- Anesthesia, Sedation, Analgesia, Airway Complication of Anesthesia
- 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 group | Role | What they receive |
|---|---|---|
| Sedation and Analgesia | Active comparator | 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. 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 Tube | Active comparator | 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. 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.
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)
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.
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
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)
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)
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.
- First posted9 Mar 2022
- Study start13 Apr 2022
- Primary completion13 Sep 2022
- Study completion20 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhittin Calim, Bezmialem Vakif University
- Investigators
- Muhittin Calim, MD, Principal investigator, Bezmialem Vakif University
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of Gastro-laryngeal Tube During Transesophageal Echocardiography: Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05272306
- Acronym / sponsor ID
- GLT / muhittincalim1
- Conditions
- Anesthesia, Sedation, Analgesia, Airway Complication of Anesthesia
- Keywords
- Anesthesia, Sedation, Analgesia, Gastro-laryngeal tube, Transesophageal echocardiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 13 Apr 2022 (actual)
- Primary completion
- 13 Sep 2022 (actual)
- Study completion
- 20 Sep 2022 (actual)
- First posted
- 9 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Prospective Randomized Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Sedation and Analgesia | Active comparator | Other: Number of attempts for successful transesophageal echocardiography, Diagnostic Test: A questionnaire for cardiologist satisfaction, Diagnostic Test: A questionnaire for patient satisfactionA 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. |
| Gastro-laryngeal Tube | Active comparator | Other: Number of attempts for successful transesophageal echocardiography, Diagnostic Test: A questionnaire for cardiologist satisfaction, Diagnostic Test: A questionnaire for patient satisfactionAfter 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. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiology (ASA) physical status I-II
- Aged 20-75 years old
Key exclusion criteria (8 listed)
- Under 20 years old
- Over 75 years old
- An allergy to anesthetic drugs
- Emergent procedure
- Uncontrolled cerebrovascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Number of attempts for successful transesophageal echocardiographyAlso: TEETransesophageal echocardiography probe will be inserted after induction of anesthesia. Number of attempts for successful transesophageal echocardiography will be recorded. | Other | Gastro-laryngeal Tube, Sedation and Analgesia |
| A questionnaire for cardiologist satisfactionAlso: QuestionnaireA questionnaire for cardiologist satisfaction will be measured on a grade of 0-4 (1= very bad, 2= bad, 3= good, 4= very good). | Diagnostic test | Gastro-laryngeal Tube, Sedation and Analgesia |
| A questionnaire for patient satisfactionAlso: QuestionnaireA questionnaire for patient satisfaction will be measured on a grade of 0-4 (1= very bad, 2= bad, 3= good, 4= very good). | Diagnostic test | Gastro-laryngeal Tube, Sedation and Analgesia |
Primary outcome
A questionnaire for cardiologist satisfaction
Time frame: A questionnaire will be performed to cardiologist 30 minutes after the procedure
A questionnaire for cardiologist satisfaction will be measured on a grade of 0-4 (1= very bad, 2= bad, 3= good, 4= very good).
5 secondary outcomes
Number of attempts for successful transesophageal echocardiography
Time frame: Transesophageal echocardiography probe will be inserted during the procedure.
A questionnaire for patient satisfaction
Time frame: A questionnaire will be performed to the all patients 2 hours after the procedure
Heart rate
Time frame: From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
Mean arterial pressure
Time frame: From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
Peripheral oxygen saturation
Time frame: From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
- Results publication: PubMed 27210780Daskaya 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhittin Calim, MD principal investigator
Bezmialem Vakif University
1 site in 1 country: see every site and its status.
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.