Nasal Intubation Using the Blind Intubation Device (BID)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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
| Condition | Intervention |
|---|---|
|
Intubation |
Device: Macintosh laryngoscope Device: Blind Intubation Device |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Nasal Intubation Using the Blind Intubation Device:a Prospective,Randomized,Controlled Comparison With the Direct Laryngoscope |
- Hemodynamic changes [ Time Frame: 1 min before general anesthesia induction ] [ Designated as safety issue: No ]
- Hemodynamic changes [ Time Frame: 5 min after general anesthesia induction ] [ Designated as safety issue: No ]
- Hemodynamic changes [ Time Frame: 30s from nasal intubation start ] [ Designated as safety issue: Yes ]
- Hemodynamic changes [ Time Frame: 1 min after nasal intubation ] [ Designated as safety issue: Yes ]
- Hemodynamic changes [ Time Frame: 2 min after nasal intubation ] [ Designated as safety issue: Yes ]
- Hemodynamic changes [ Time Frame: 3 min after nasal intubation ] [ Designated as safety issue: Yes ]
- hemodynamic changes [ Time Frame: 4 min from nasal intubation start ] [ Designated as safety issue: Yes ]
- hemodynamic changes [ Time Frame: 5 min from nasal intubation start ] [ Designated as safety issue: Yes ]
- intubation time required [ Time Frame: 0 min after nasal intubation ] [ Designated as safety issue: Yes ]from taking of the intubation device to successful intubation
- immediate associated airway complications [ Time Frame: 5 min after nasal intubation ] [ Designated as safety issue: Yes ]mucosal injury,dental injury,airway injury,bleeding, etc
- 24h associated airway complications [ Time Frame: 24h after intubation ] [ Designated as safety issue: Yes ]sore throat, hoarseness, etc
| Estimated Enrollment: | 50 |
| Study Start Date: | September 2010 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
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| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| China, Shanghai | |
| Department of Anesthesiology, Shanghai 9th People's Hospital | |
| Shanghai, Shanghai, China, 200011 | |
| Study Chair: | Jiang Hong, PhD,MD | Shanghai 9th People's Hospital |
| Principal Investigator: | Sun Yu, PhD,MD | Shanghai 9th People's Hospital |
| Principal Investigator: | Liu J Xing, MD | Shanghai 9th People's Hospital |
| Principal Investigator: | Xu Hui, MD | Shanghai 9th People's Hospital |
| Principal Investigator: | Huang Yan, MD | Shanghai 9th People's Hospital |
| Study Director: | Zhu Y Sen, MD | Shanghai 9th People's Hospital |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Shanghai Ninth People's Hospital, Hong Jiang |
| ClinicalTrials.gov Identifier: | NCT01170455 History of Changes |
| Other Study ID Numbers: | Shanghai 9th People's Hospital |
| Study First Received: | July 21, 2010 |
| Last Updated: | October 28, 2010 |
| Health Authority: | China: State Food and Drug Administration |
Keywords provided by Shanghai Jiao Tong University School of Medicine:
|
nasal intubation direct laryngoscope blind normal airway |
ClinicalTrials.gov processed this record on October 17, 2012
