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Fiberoptic Intubation and Transillumination-guided Fiberoptic Intubation:Success Rate and Time in Untrained Medical Personnel

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yang Tao, Second Military Medical University
ClinicalTrials.gov Identifier:
NCT01129726
First received: May 18, 2010
Last updated: February 15, 2012
Last verified: February 2012
  Purpose
Fiberoptic Intubation is the preferred technique to difficult airway. However, when performed by untrained anesthesiologists, bronchoscopic intubation has a high rate of failure. We want to know if the Transillumination-guided Fiberoptic Intubation technique can improves the success rate and time for tracheal intubation performed by inexperienced anesthesiologists; whether this technique improves the success rate and for normal intubations when performed by inexperienced anesthesiologists as well is unknown. Therefore, the authors compared the success rate and time of Fiberoptic Intubation versus the Transillumination-guided Fiberoptic Intubation performed by anesthesiologists inexperienced in Fiberoptic Intubation.

Condition Intervention
Transillumination-guided Fiberoptic Intubation Intubation Device: Transillumination-guided Fiberoptic Intubation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Official Title: Fiberoptic Intubation and Transillumination-guided Fiberoptic Intubation:Time and Success Rate in Untrained Medical Personnel

Further study details as provided by Yang Tao, Second Military Medical University:

Primary Outcome Measures:
  • time to intubation [ Time Frame: Within 3 month ]

Secondary Outcome Measures:
  • success rate and postoperative side effect [ Time Frame: 2 months ]

Enrollment: 100
Study Start Date: May 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intubation
Transillumination-guided Fiberoptic Intubation
Device: Transillumination-guided Fiberoptic Intubation
Light guided, Non-invasive
Other Name: Light guided Bronchoscopic Intubation Technique

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • neck and maxillofacial surgeries
  • potential risks for regurgitation and pulmonary aspiration
  • in pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01129726

Locations
China, Shanghai
Changhai Hospital Affiliated to Second Military Medical University
Shanghai, Shanghai, China, 200433
China
Changhai Hospital affiliated to Second Military Medical University
Shanghai, China, 200433
Sponsors and Collaborators
Second Military Medical University
Investigators
Study Chair: XiaoMing Deng, Ph.D. Second Military Medical University
  More Information

Responsible Party: Yang Tao, Department of Anesthesiology and Cirtical Care Medicine, Changhai Hospital, Second Military Medical University
ClinicalTrials.gov Identifier: NCT01129726     History of Changes
Other Study ID Numbers: 20100002
Light Guided ( Other Identifier: SMMU )
Study First Received: May 18, 2010
Last Updated: February 15, 2012

Keywords provided by Yang Tao, Second Military Medical University:
Transillumination-guided
Fiberoptic Intubation
time
success rate
intubation

ClinicalTrials.gov processed this record on June 27, 2017