Department of Anesthesiology, Shanghai 9th People's Hospital
Shanghai, Shanghai Municipality, 200011, China
NCT Number: NCT01170455
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
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Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Shanghai, Shanghai Municipality, 200011, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
nasal intubation with macintosh laryngoscope after general anesthesia induction
nasal intubation using Blind Intubation Device after general anesthesia induction
Time frame: 1 min before general anesthesia induction
Time frame: 5 min after general anesthesia induction
Time frame: 30s from nasal intubation start
Time frame: 1 min after nasal intubation
Time frame: 2 min after nasal intubation
Time frame: 3 min after nasal intubation
Time frame: 4 min from nasal intubation start
Time frame: 5 min from nasal intubation start
Time frame: 0 min after nasal intubation
from taking of the intubation device to successful intubation
Time frame: 5 min after nasal intubation
mucosal injury,dental injury,airway injury,bleeding, etc
Time frame: 24h after intubation
sore throat, hoarseness, etc
Shanghai Jiao Tong University School of Medicine
Other
Nasal Intubation Using the Blind Intubation Device:a Prospective,Randomized,Controlled Comparison With the Direct Laryngoscope
Acronym: BID
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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