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A Comparison of Direct Laryngoscopy With Blind Intubation Via Intubating Laryngeal Tube Suction Disposable

B

Bnai Zion Medical Center

Status

Unknown

Conditions

Adverse Anesthesia Outcome

Treatments

Device: Direct Laryngoscopy
Device: Intubating Laryngeal Tube Suction

Study type

Interventional

Funder types

Other

Identifiers

NCT02884895
BnaiZionMC-16-LG-007

Details and patient eligibility

About

Tracheal intubation is an important part of treatment for a trauma casualty. Tracheal intubation is usually achieved by a direct laryngoscope.It is an effective method but requires experience and skill demanding a long learning time.The use of the Laryngeal Tube Suction for fast control of the airway is known for many years. The Intubating Laryngeal Tube Suction is a new version of the Laryngeal Tube. The aim of this study is to examine the effectiveness of the the Intubating Laryngeal Tube Suction to achieve a definitive airway by unskilled practitioners in anesthetized patients with the head in neutral position (trauma model).

Full description

Control the airways and respiration are an important part of treatment for a trauma casualty. Tracheal intubation an action that allows the insertion of a tube through the vocal cords and fixation by the balloon inflation is a definitive airway.

Tracheal intubation is usually achieved by a direct laryngoscope. This method is taught both in the training of doctors and paramedics training. Although it is an effective method requires experience and skill demanding a long learning time The use of the Laryngeal Tube Suction for fast control of the airway is known for many years. The Laryngeal Tube Suction and others similar devices are known as Supraglottic Airway Devices and are inserted blind in the oropharynx and allow a fast oxygenation and ventilation of the patients.

The new generation of these devices allows perform blind intubation directly through a special channel. One of these devices is the Intubating Laryngeal Tube Suction

The aim of this study is to examine the effectiveness of the Intubating Laryngeal Tube Suction to achieve a definitive airway by unskilled practitioners in anesthetized patients with the head in neutral position (trauma model).

The hypothesis is that definitive airway obtaining with Intubating Laryngeal Tube Suction will be more success and faster compared to the standard way of direct laryngoscope. If the hypothesis is proven, this research will be very important implications for the management of the airway describing pre-hospital and in particular military scenarios.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • American Society Anesthesiology class I and II

Exclusion criteria

  • Difficult airways
  • Cervical pathology
  • Full stomach

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

60 participants in 2 patient groups

Intubating laryngeal Tube Suction
Experimental group
Description:
Intubating laryngeal Tube Suction
Treatment:
Device: Intubating Laryngeal Tube Suction
Direct Laryngoscopy
Active Comparator group
Description:
Direct Laryngoscopy
Treatment:
Device: Direct Laryngoscopy

Trial contacts and locations

0

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Central trial contact

Mostafa Somri, M.D.; Luis A Gaitini, M.D.

Data sourced from clinicaltrials.gov

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