Nasal Intubation Using the Blind Intubation Device

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2010-10-31

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.

Conditions

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Intubation

Keywords

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nasal intubation direct laryngoscope blind normal airway

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Blind Intubation Device

Group Type EXPERIMENTAL

Blind Intubation Device

Intervention Type DEVICE

nasal intubation using Blind Intubation Device after general anesthesia induction

Direct laryngoscope

Group Type ACTIVE_COMPARATOR

Macintosh laryngoscope

Intervention Type DEVICE

nasal intubation with macintosh laryngoscope after general anesthesia induction

Interventions

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Macintosh laryngoscope

nasal intubation with macintosh laryngoscope after general anesthesia induction

Intervention Type DEVICE

Blind Intubation Device

nasal intubation using Blind Intubation Device after general anesthesia induction

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Hong Jiang