Nasal Intubation Using the Blind Intubation Device (BID)

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

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

Study Overview

• Status: Completed
• Conditions: Intubation
• Intervention / Treatment: Device: Blind Intubation Device; Device: Macintosh laryngoscope

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200011
      • Department of Anesthesiology, Shanghai 9th People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Blind Intubation Device	Device: Blind Intubation Device; nasal intubation using Blind Intubation Device after general anesthesia induction
Active Comparator: Direct laryngoscope	Device: Macintosh laryngoscope; nasal intubation with macintosh laryngoscope after general anesthesia induction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine
• Collaborators: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Investigators: Study Chair: Jiang Hong, PhD,MD, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University; Principal Investigator: Sun Yu, PhD,MD, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University; Principal Investigator: Liu J Xing, MD, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University; Principal Investigator: Xu Hui, MD, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University; Principal Investigator: Huang Yan, MD, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University; Study Director: Zhu Y Sen, MD, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Publications and helpful links

General Publications

• Sun Y, Liu JX, Jiang H, Zhu YS, Xu H, Huang Y. Cardiovascular responses and airway complications following awake nasal intubation with blind intubation device and fibreoptic bronchoscope: a randomized controlled study. Eur J Anaesthesiol. 2010 May;27(5):461-7. doi: 10.1097/EJA.0b013e328332845a.
• Sun Y, Jiang H, Zhu Y, Xu H, Huang Y. Blind intubation device for nasotracheal intubation in 100 oral and maxillofacial surgery patients with anticipated difficult airways: a prospective evaluation. Eur J Anaesthesiol. 2009 Sep;26(9):746-51. doi: 10.1097/EJA.0b013e32832b13a2.
• Sun Y, Liu JX, Zhu YS, Xu H, Huang Y, Jiang H. Nasotracheal intubation using the Blind Intubation Device in anaesthetised adults with Mallampati class 3: a comparison with the Macintosh laryngoscope. Eur J Anaesthesiol. 2011 Nov;28(11):774-80. doi: 10.1097/EJA.0b013e328349a9f9.

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: July 21, 2010
• First Submitted That Met QC Criteria: July 26, 2010
• First Posted (Estimate): July 27, 2010

Study Record Updates

• Last Update Posted (Estimate): October 29, 2010
• Last Update Submitted That Met QC Criteria: October 28, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: nasal; intubation; blind; direct laryngoscope; normal airway
• Other Study ID Numbers: Shanghai 9th People's Hospital