Nasal Intubation Using the Blind Intubation Device

Intubation Clinical Trial

— BID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01170455
• Other study ID #: Shanghai 9th People's Hospital
• Status: Completed
• Phase: N/A
• First received: July 21, 2010
• Last updated: October 28, 2010
• Start date: September 2010
• Est. completion date: October 2010

Study information

• Verified date: September 2010
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intubation

Intervention

Device:
• Macintosh laryngoscope
nasal intubation with macintosh laryngoscope after general anesthesia induction
• Blind Intubation Device
nasal intubation using Blind Intubation Device after general anesthesia induction

Locations

Country	Name	City	State
China	Department of Anesthesiology, Shanghai 9th People's Hospital	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine	Shanghai 9th People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemodynamic changes		1 min before general anesthesia induction	No
Primary	Hemodynamic changes		5 min after general anesthesia induction	No
Primary	Hemodynamic changes		30s from nasal intubation start	Yes
Primary	Hemodynamic changes		1 min after nasal intubation	Yes
Primary	Hemodynamic changes		2 min after nasal intubation	Yes
Primary	Hemodynamic changes		3 min after nasal intubation	Yes
Primary	hemodynamic changes		4 min from nasal intubation start	Yes
Primary	hemodynamic changes		5 min from nasal intubation start	Yes
Secondary	intubation time required	from taking of the intubation device to successful intubation	0 min after nasal intubation	Yes
Secondary	immediate associated airway complications	mucosal injury,dental injury,airway injury,bleeding, etc	5 min after nasal intubation	Yes
Secondary	24h associated airway complications	sore throat, hoarseness, etc	24h after intubation	Yes