Nasal Intubation Using the Blind Intubation Device (BID)

This study has been completed.
Sponsor:
Collaborator:
Shanghai 9th People's Hospital
Information provided by:
Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT01170455
First received: July 21, 2010
Last updated: October 28, 2010
Last verified: September 2010
  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

Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01170455

Locations
China, Shanghai
Department of Anesthesiology, Shanghai 9th People's Hospital
Shanghai, Shanghai, China, 200011
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Shanghai 9th People's Hospital
Investigators
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: 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 April 17, 2014