NCT01116999

Brief Summary

The investigators hypothesise that, for novices, light guided tracheal intubation will improve the time and success rate of this clinical skill compared to standard direct tracheal intubation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2010

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

Study Start

First participant enrolled

May 1, 2010

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 4, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 5, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

September 27, 2011

Status Verified

September 1, 2011

Enrollment Period

10 months

First QC Date

May 4, 2010

Last Update Submit

September 25, 2011

Conditions

Outcome Measures

Primary Outcomes (1)

  • Ease to intubate (time and success rate required to perform intubation)

    Within 8 months

Study Arms (1)

Tracheal intubation

EXPERIMENTAL
Procedure: light guided tracheal intubation

Interventions

Tracheal intubation light guided technique.

Also known as: intubation
Tracheal intubation

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • age range 18\~55 years
  • general anesthesia
  • ASA I\~II
  • Mallampati Score grade I\~II
  • thyromental distance ≥6cm
  • mouth-open ≥3cm
  • body mass index (BMI) ≤30kg/m2

You may not qualify if:

  • neck and maxillofacial surgeries
  • temporomandibular joint (TMJ) disease
  • potential risks for regurgitation and pulmonary aspiration
  • in pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changhai Hospital Affiliated to Second Military Medical University

Shanghai, Shanghai Municipality, 200433, China

Location

MeSH Terms

Interventions

Intubation

Intervention Hierarchy (Ancestors)

TherapeuticsInvestigative Techniques

Study Officials

  • Tao Yang, MD

    Department of Anesthesiology and Cirtical Care Medicine, Changhai Hospital Affiliated to Second Military Medical University

    STUDY DIRECTOR
  • Jiong Hou, MD

    Department of Anesthesiology and Cirtical Care Medicine, Changhai Hospital Affiliated to Second Military Medical University

    STUDY DIRECTOR
  • Xiaoming Deng, Professor

    Department of Anesthesiology and Cirtical Care Medicine, Changhai Hospital Affiliated to Second Military Medical University

    STUDY DIRECTOR
  • Xu Zhang, MD

    Department of Anesthesiology and Cirtical Care Medicine, Changhai Hospital Affiliated to Second Military Medical University

    PRINCIPAL INVESTIGATOR
  • Wen Ni, MD

    Department of Anesthesiology and Cirtical Care Medicine, Changhai Hospital Affiliated to Second Military Medical University

    PRINCIPAL INVESTIGATOR
  • Xiaoyan Zhu, MD

    Second Military Medical University

    PRINCIPAL INVESTIGATOR
  • Jinbao Li, MD

    Department of Anesthesiology and Cirtical Care Medicine, Changhai Hospital Affiliated to Second Military Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Anesthesiology and Cirtical Care Medicine, Changhai Hospital

Study Record Dates

First Submitted

May 4, 2010

First Posted

May 5, 2010

Study Start

May 1, 2010

Primary Completion

March 1, 2011

Study Completion

April 1, 2011

Last Updated

September 27, 2011

Record last verified: 2011-09

Locations