Nasal Intubation Using the Blind Intubation Device

Study Overview
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Brief Summary
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The purpose of this study is to determine whether nasal tracheal intubation using Blind Intubation Device is safe and effective in anesthetized patients with Mallampati class 3

Detailed Description
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The Blind Intubation Device (BID,Anhui Xiao Shan Hygienic Material Co.Ltd,Jixi County,China) is newly introduced for awake nasal intubation using a transillumination principle. For oral and maxillofacial surgery patients with anticipated difficult airways, the BID has a high rate of successful awake nasal intubation.Since the BID is more readily accessible,disposable and considerably less expensive,these advantages speak well for its use in China.However,to date,there is no study on its usage in anesthetized patients.The investigators hypothesized that a BID would be effective for nasal intubation in anesthetized patients with high Mallampati class and would result in fewer hemodynamic responses. To examine our hypothesis, the investigators would like to perform a prospective,randomized,controlled study to compare the effectiveness of the BID technique with a direct laryngoscope for nasal intubation in anesthetized patients with Mallampati class 3. The primary outcome measures are the hemodynamic changes during intubation. The investigators also would like to compare the intubation time required and associated airway complications in both groups as our second outcome.

Official Title
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Nasal Intubation Using the Blind Intubation Device:a Prospective,Randomized,Controlled Comparison With the Direct Laryngoscope

Conditions
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Intubation

Intervention / Treatment
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* Device: Macintosh laryngoscope
* Device: Blind Intubation Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA physical status 1-2 Scheduled for oral and maxillofacial surgery under general anesthesia with nasotracheal intubation mallampati score 3 Exclusion Criteria: ASA physical status 3-4 Patients with a history of intraoral,upper airway and neck surgeries Patients with a history of chronic respiratory, cardiovascular or any other systemic diseases morbid obesity neck scars mallampati score 4,inter-incisor distance<3cm, thyromental distance<6cm unstable cervical spine relevant drug allergy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blind Intubation Device<br> | Device: Blind Intubation Device<br>* nasal intubation using Blind Intubation Device after general anesthesia induction<br>|
| Active Comparator: Direct laryngoscope<br> | Device: Macintosh laryngoscope<br>* nasal intubation with macintosh laryngoscope after general anesthesia induction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemodynamic changes |  | 1 min before general anesthesia induction | 
| Hemodynamic changes |  | 5 min after general anesthesia induction | 
| Hemodynamic changes |  | 30s from nasal intubation start | 
| Hemodynamic changes |  | 1 min after nasal intubation | 
| Hemodynamic changes |  | 2 min after nasal intubation | 
| Hemodynamic changes |  | 3 min after nasal intubation | 
| hemodynamic changes |  | 4 min from nasal intubation start | 
| hemodynamic changes |  | 5 min from nasal intubation start | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intubation time required | from taking of the intubation device to successful intubation | 0 min after nasal intubation | 
| immediate associated airway complications | mucosal injury,dental injury,airway injury,bleeding, etc | 5 min after nasal intubation | 
| 24h associated airway complications | sore throat, hoarseness, etc | 24h after intubation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nasal, intubation, direct laryngoscope, blind, normal airway