Gastro-laryngeal Tube During Transesophageal Echocardiography
GLT
The Utility of Gastro-laryngeal Tube During Transesophageal Echocardiography: Prospective Randomized Clinical Trial
1 other identifier
interventional
42
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2022
CompletedFirst Posted
Study publicly available on registry
March 9, 2022
CompletedStudy Start
First participant enrolled
April 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 13, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 20, 2022
CompletedSeptember 29, 2022
September 1, 2022
5 months
February 28, 2022
September 28, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (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).
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 during the procedure.
A questionnaire for patient satisfaction
A questionnaire will be performed to the all patients 2 hours after the procedure
Heart rate
From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
Mean arterial pressure
From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
Peripheral oxygen saturation
From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
Study Arms (2)
Sedation and Analgesia
ACTIVE 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.
Gastro-laryngeal Tube
ACTIVE 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.
Interventions
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).
Eligibility Criteria
You may qualify if:
- American Society of Anesthesiology (ASA) physical status I-II
- Aged 20-75 years old
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Muhittin Calim
Istanbul, Fatih, 34093, Turkey (Türkiye)
Related Publications (1)
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.
PMID: 27210780RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Muhittin Calim, MD
Bezmialem Vakif University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 28, 2022
First Posted
March 9, 2022
Study Start
April 13, 2022
Primary Completion
September 13, 2022
Study Completion
September 20, 2022
Last Updated
September 29, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share