Nasal Intubation Using the Blind Intubation Device

Not Applicable

Completed

• Conditions: Intubation
• Interventions: Device: Blind Intubation Device; Device: Macintosh laryngoscope

• Registration Number: NCT01170455
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2010-07-21
• Study First Submitted QC: 2010-07-26
• Study First Posted: 2010-07-27
• Status Verified: 2010-09
• Study Start: 2010-09
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Last Update Submitted: 2010-10-28
• Last Update Posted: 2010-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Blind Intubation Device	Blind Intubation Device	-
Direct laryngoscope	Macintosh laryngoscope	-

Primary Outcome Measures

Name	Time	Method
Hemodynamic changes	3 min after nasal intubation
hemodynamic changes	5 min from nasal intubation start

Secondary Outcome Measures

Name	Time	Method
intubation time required	0 min after nasal intubation	from taking of the intubation device to successful intubation
immediate associated airway complications	5 min after nasal intubation	mucosal injury,dental injury,airway injury,bleeding, etc
24h associated airway complications	24h after intubation	sore throat, hoarseness, etc

Trial Locations

Locations (1)

Department of Anesthesiology, Shanghai 9th People's Hospital; 🇨🇳 Shanghai, Shanghai, China