NCT01170455

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 27, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

October 29, 2010

Status Verified

September 1, 2010

Enrollment Period

1 month

First QC Date

July 21, 2010

Last Update Submit

October 28, 2010

Conditions

Intubation

Keywords

nasalintubationdirect laryngoscopeblindnormal airway

Outcome Measures

Primary Outcomes (8)

  • 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

Secondary Outcomes (3)

  • intubation time required

    0 min after nasal intubation

  • immediate associated airway complications

    5 min after nasal intubation

  • 24h associated airway complications

    24h after intubation

Study Arms (2)

Blind Intubation Device

EXPERIMENTAL
Device: Blind Intubation Device

Direct laryngoscope

ACTIVE COMPARATOR
Device: Macintosh laryngoscope

Interventions

Macintosh laryngoscopeDEVICE

nasal intubation with macintosh laryngoscope after general anesthesia induction

Direct laryngoscope
Blind Intubation DeviceDEVICE

nasal intubation using Blind Intubation Device after general anesthesia induction

Blind Intubation Device

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ASA physical status 1-2
  • Scheduled for oral and maxillofacial surgery under general anesthesia with nasotracheal intubation
  • mallampati score 3

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, Shanghai 9th People's Hospital

Shanghai, Shanghai Municipality, 200011, China

Location

Related Publications (3)

  • 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.

    PMID: 20090540BACKGROUND

  • 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.

    PMID: 19451824BACKGROUND

  • 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.

    PMID: 21885980DERIVED

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 21, 2010

First Posted

July 27, 2010

Study Start

September 1, 2010

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

October 29, 2010

Record last verified: 2010-09

Locations

CN(1)