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| Name | Class |
|---|---|
| Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blind Intubation Device | Experimental |
| |
| Direct laryngoscope | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Macintosh laryngoscope | Device | nasal intubation with macintosh laryngoscope after general anesthesia induction |
|
| Measure | Description | 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jiang Hong, PhD,MD | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | Study Chair |
| 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 | Principal Investigator |
| Zhu Y Sen, MD | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology, Shanghai 9th People's Hospital | Shanghai | Shanghai Municipality | 200011 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20090540 | Background | 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. | |
| 19451824 | Background |
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| Blind Intubation Device | Device | nasal intubation using Blind Intubation Device after general anesthesia induction |
|
| 5 min after nasal intubation |
| 24h associated airway complications | sore throat, hoarseness, etc | 24h after intubation |
| 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. |
| 21885980 | Derived | 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. |