Clinical trial NCT01170455: Nasal Intubation Using the Blind Intubation Device
Official title: Nasal Intubation Using the Blind Intubation Device:a Prospective,Randomized,Controlled Comparison With the Direct Laryngoscope
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation
Keywords: nasal
intubation
direct laryngoscope
blind
normal airway
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
First posted: 2010-07-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hemodynamic changes
timeFrame: 1 min before general anesthesia induction
measure: Hemodynamic changes
timeFrame: 5 min after general anesthesia induction
measure: Hemodynamic changes
timeFrame: 30s from nasal intubation start
measure: Hemodynamic changes
timeFrame: 1 min after nasal intubation
measure: Hemodynamic changes
timeFrame: 2 min after nasal intubation
measure: Hemodynamic changes
timeFrame: 3 min after nasal intubation
measure: hemodynamic changes
timeFrame: 4 min from nasal intubation start
measure: hemodynamic changes
timeFrame: 5 min from nasal intubation start
Secondary outcomes:
measure: intubation time required
timeFrame: 0 min after nasal intubation
measure: immediate associated airway complications
timeFrame: 5 min after nasal intubation
measure: 24h associated airway complications
timeFrame: 24h after intubation
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Anesthesiology, Shanghai 9th People's Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
name: Jiang Hong, PhD,MD
role: STUDY_CHAIR
affiliation: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
name: Sun Yu, PhD,MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
name: Liu J Xing, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
name: Xu Hui, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
name: Huang Yan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
name: Zhu Y Sen, MD
role: STUDY_DIRECTOR
References:
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.
citation: 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.
citation: 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.