Clinical Trials Logo
  1. Home
  2. Difficult Intubation
  3. NCT05347680
  4. Details
NCT05347680 Clinical Trial

A Comparison Between the Intubating Laryngeal Tube Suction and the Ambu AuraGain

Difficult Intubation Clinical Trial

Official title:
A Prospective and Randomized Study Comparing Fiberoptic Intubation Through the New Intubating Laryngeal Tube Suction and the Ambu AuraGain in Adult Patients Secondary IDs:

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05347680
Other study ID # 0132-16
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 19, 2019
Est. completion date January 18, 2021

Study information
Verified date April 2022
Source Bnai Zion Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The intubating Laryngeal Tube Suction-Disposable is a new version of the Laryngeal Tube-Suction. It has a ventilator channel with a 13.5mm internal diameter, which enables the passage of an Endotracheal Tube with fiberoptic guidance. This study was designed to assess the Time fiberoptic endotracheal intubation using iLTS-D, in comparison with the and Ambu® AuraGain™ in adult patients.

Description:

The intubating Laryngeal Tube Suction-Disposable is a new version of the Laryngeal Tube-Suction. It has a ventilator channel with a 13.5mm internal diameter, which enables the passage of an Endotracheal Tube with fiberoptic guidance. This study was designed to assess the Time of fiberoptic endotracheal intubation using iLTS-D, in comparison with the and Ambu® AuraGain™ in adult patients. Detailed Description: The intubating Laryngeal Tube Suction-Disposable (iLTS-D) (VBM Medizintechnik GmbH, Sulz, Germany) is a new updated version of the Laryngeal Tube-Suction Disposable (LTS-D) It has a ventilator channel with a 13.5mm internal diameter, which enables the passage of an Endotracheal Tube (ETT) with fiberoptic guidance. Similarly as in to the LTS-D, the iLTS-D also has a separate channel for the purpose of placement of gastric tubes placement up to a size of 18 Fr. The iLTS-D comes in one size. According to the depth of insertion, this device is equivalent to size 4 for patients height 175 to 190 cm tall, or size 5 for patients taller than 190 cm. The iLTS-D is provided by the manufacturer with a compatible 7.5 mm ETT and with a plastic stabilizer for removal of the device. The current randomized study was designed to assess the success rate fiberoptic endotracheal intubation using iLTS-D, in comparison with the and Ambu® AuraGain™ in adult patients under general anesthesia

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date January 18, 2021
Est. primary completion date January 15, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - American Society Anesthesiology I and II Exclusion Criteria: - Difficult intubation - Cervical pathology - pregnancy

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Intubating Laryngeal Tube Suction
Intubating Laryngeal Tube Suction
• Ambu AuraGain Laryngeal Mask
Ambu AuraGain Laryngeal Mask

Locations
Country Name City State
Israel Luis A Gaitini M.D. Haifa

Sponsors (1)
Lead Sponsor Collaborator
Bnai Zion Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time to perform fiberoptic intubation through supraglottic device in second Time to perform endotracheal fiberoptic intubation through supraglottic device in second 120 seconds
Secondary Success to obtain fiberoptic intubation through supraglottic device in second Success to obtain endotracheal fiberoptic intubation through supraglottic device in second 120 seconds
See also
  Status Clinical Trial Phase
Completed NCT03657927 - A Comparison of McGrath MAC Versus C-MAC Videolaryngoscopes in Morbidly Obese Patients N/A
Enrolling by invitation NCT04506346 - Risk Prediction of Difficult Tracheal Intubation in OSAHS Patient
Completed NCT02944305 - A Predictive Model for Difficult Intubation N/A
Completed NCT02476565 - Comparison of Endotracheal Intubation Over the Aintree Via the I-gel and Laryngeal Mask Airway Supreme N/A
Completed NCT02823392 - Difficult Bag Mask Ventilation and Difficult Intubation in Children
Completed NCT03265938 - Evaluation of Video Laryngoscopy in Patients With Head and Neck Pathology
Completed NCT05545982 - Comparison of Video Laryngoscope Using Miller or Macintosh Approach During Endotracheal Intubation N/A
Completed NCT03320278 - The Evaluation of Simplified Predictive Intubation Difficulty Score.
Completed NCT01532063 - Risk Factors of Difficult Intubation and Related Complications in Adults in Intensive Care Units: FRIDA-Rea N/A
Completed NCT03709524 - Orotracheal Intubation in Adult Patients: A Comparison of Standard Airtraq , Nasotracheal Airtraq Combined With a Stylet Inserted Endotracheal Tube and Standard Airtraq Combined Fiberoptic Intubation N/A
Recruiting NCT03902704 - Safety and Efficacy of Cleverscope. A New Medical Device for Tracheal Intubation N/A
Not yet recruiting NCT05607433 - Air Q Laryngeal Airway Versus the AmbuAura Gain as a Conduit for Endotracheal Intubation N/A
Completed NCT02814266 - Difficult Intubation and Anthropometric Measurement N/A
Active, not recruiting NCT04759287 - Effectiveness of C-MAC Video-stylet Versus Fiberoptic Bronchoscope for Awake Intubation N/A
Completed NCT03547193 - Two Neck Ultrasound Measurements as Predictors of Difficult Laryngoscopy
Completed NCT04822831 - The Effect of Semi-recumbent Position With Exercise Training on Long-term Ventilator-dependent Patients N/A
Completed NCT03165461 - Evaluation of the Use of Tracheal Intubation Through a Laryngeal Tube to Intubate Anesthetized Patients
Recruiting NCT02177240 - A Comparison of the Flex-it® to the GlideRite® Stylet for GlideScope® in Simulated Difficult Intubations. N/A
Recruiting NCT01612949 - Facial Analysis to Classify Difficult Intubation
Completed NCT04168840 - Ultrasound Parameters to Predict Difficult Airway