Tracheal Intubation With the Rigid Tube for Laryngoscopy- a New Method

Study Overview
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Brief Summary
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This study evaluates the efficiency of the rigid tube for laryngoscopy for tracheal intubation in patients with presumed difficult airway and compare the classical laryngoscopy and this method in matter of glottis visualisation and tracheal intubation.

Detailed Description
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The rigid tube for laryngoscopy is a 15 to 30 cm long metallic tube with a bevel end and a diameter of 0.5-2.0 cm , an instrument used to inspect the larynx and surrounding areas. It resembles a rigid bronchoscope but it is shorter. When in use, it has to be attached to a light source. The hypothesis of the study stands that the rigid tube for laryngoscopy could be more efficient in tracheal intubation for difficult airway patients when the classical intubation with a curved blade laryngoscope is unsatisfactory. The retromolar approach in both sides together with bougie(intubating tube introducer) intubation is the technique of intubation used in this study.

Official Title
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A Comparative Study Between the Rigid Tube for Laryngoscopy, as a New Tool for Tracheal Intubation, and McIntosh Laryngoscope in Difficult Airway Patients

Conditions
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Intubation;Difficult

Intervention / Treatment
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* Device: classical laryngoscopy
* Device: rigid tube for laryngoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with criteria of anatomically difficult airway from SARI (The Simplified Airway Risk Index Scale) parameters analysis patients with airway pathology which predicted difficult intubation: tumors or cervical masses, previous radiotherapy or surgery Exclusion Criteria: stridor or marked laryngeal or tracheal stenosis, vocal cords polyps emergency surgery, decompensated cardiac or pulmonary disease grade 1 and 2a at classical laryngoscopy after Cormack- Lehane Classification

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: A group of patients with difficult airway criteria will be intubated using the rigid tube for laryngoscopy. A classical laryngoscopy with a McIntosh laryngoscope will be performed prior intubation and the Cormack-Lehane grade of glottis visualisation will be noted. If the Cormack -Lehane grade of glotic visualisation 2b, 3 or 4, the intubation maneuvre is carried further with the rigid tube. If the Cormack-Lehane glottic visualisation grade is less than 2b (1 or 2a) the intubation is accomplished with the MacIntosh laryngoscope (conventional laryngoscope) and the patient is excluded from the study from that point further.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: laryngoscopy and tracheal intubation<br>Tracheal intubation with the rigid tube for laryngoscopy for patients with difficult airway. Prior the use of rigid tube for laryngoscopy, a classical laryngoscopy with a McIntosh laryngoscope will be performed. | Device: classical laryngoscopy<br>* the laryngoscopy with the McIntosh laryngoscope performed prior the use of rigid tube and the Cormack-Lehane glottis visualisation noted.<br>* Other names: laryngoscopy with McIntosh curved blade laryngoscope;Device: rigid tube for laryngoscopy<br>* the view of glottis achieved with the rigid tub for laryngoscopy and tracheal intubation with an elastic gum bougie performed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Tracheal Intubation With the Rigid Tube | the time from starting to use the rigid tube for laryngoscopy until the airway was secured. | 120 seconds | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications During Intubation With Rigid Tube | complications noticed during the use of rigid tube - hypoxia defined as oxygen saturation less than 80% | 5 minutes | 
| Late Complications of Intubation With Rigid Tube | complications noticed following the use of rigid tube - sore throat, upper lip injury. | 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laryngoscopy, retromolar