Three-dimensional Craniofacial Phenotyping of Patients With Difficult Airway

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of Rochester
Sponsor:
Information provided by (Responsible Party):
Jacek Wojtczak, University of Rochester
ClinicalTrials.gov Identifier:
NCT01630694
First received: August 16, 2011
Last updated: July 31, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to identify differences in craniofacial morphology and tongue size between patients who have a history of difficult airway management and a control group of patients who had an uneventful airway management during induction of general anesthesia. In this study the investigators want to validate the hypothesis that there are craniofacial phenotypic differences between patients who have a history of difficult airway management and a control group of patients who have had an uneventful airway management during the induction of general anesthesia.


Condition Intervention
Failed or Difficult Intubation
Procedure: 3D Laser Scanning of the Head
Procedure: Measurements and Digital Photo's of the head, neck and Mouth
Procedure: Ultrasound Exam of the Tongue

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Three -Dimensional (3-D) Craniofacial Phenotyping of Patients With Difficult Airway

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Identification of the characteristic facial features [ Time Frame: end of study approximately one year ] [ Designated as safety issue: No ]
    Identification of the characteristic facial features, upper and lower face linear and volumetric ratios, as well as tongue sizes and hyomental distance in patients who have a history of difficult airway management and a control group of patients who had an uneventful airway management during induction of general anesthesia.


Secondary Outcome Measures:
  • Optimization of facial data processing to perform automatic analysis, 2D to 3D data conversion [ Time Frame: end of study approximately one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: July 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Difficult intubation patients
patients who were difficult to intubate during previous anesthetics provided by the staff anesthesiologists.
Procedure: 3D Laser Scanning of the Head
Five scans will be collected from different angles, each scan taking approximately 3 seconds. Each scan will consist of a thin beam of light flashing of your head.
Other Name: 3D digitizing Konica Minolta 3D laser scanner
Procedure: Measurements and Digital Photo's of the head, neck and Mouth
Prior to the photographs, certain bone and soft tissue areas such as angle of the jaw, neck and chin will be gently touched and marked with self-adhesive paper stickers. Using the self-adhesive paper stickers and a measuring tape, we obtain measurements of your head and neck.Digital Photographs of your Mouth - You will be also asked to open your mouth and a digital photograph of the back of the mouth will be taken, as well as, pictures of the front and side of the head and neck.
Other Name: 3D digitizing konica minolta 3D laser scanner
Procedure: Ultrasound Exam of the Tongue
The ultrasound study of the tongue will be performed after the series of laser scans. You will be examined in the sitting position. A small,handheld, curved ultrasound instrument will be placed under the chin to take images of the tongue. This exam should take less than a minute.
Other Name: General Electric Total Access ultrasound
Placebo Comparator: Control
The control group will consist of patients with the easy laryngoscopy and intubation, recruited prospectively.
Procedure: 3D Laser Scanning of the Head
Five scans will be collected from different angles, each scan taking approximately 3 seconds. Each scan will consist of a thin beam of light flashing of your head.
Other Name: Konica Minolta 3D Digitizing Konica Minolta 3D laser scanner
Procedure: Measurements and Digital Photo's of the head, neck and Mouth
Prior to the photographs, certain bone and soft tissue areas such as angle of the jaw, neck and chin will be gently touched and marked with self-adhesive paper stickers. Using the self-adhesive paper stickers and a measuring tape, we obtain measurements of your head and neck. You will be also asked to open your mouth and a digital photograph of the back of the mouth will be taken, as well as, pictures of the front and side of the head and neck.
Other Name: General Electric Total access ultrasound
Procedure: Ultrasound Exam of the Tongue
The ultrasound study of the tongue will be performed after the series of laser scans. You will be examined in the sitting position. A small,handheld, curved ultrasound instrument will be placed under the chin to take images of the tongue. This exam should take less than a minute
Other Name: General Electric Total access ultrasound

Detailed Description:

Difficult airway management is one of the most challenging tasks for anesthesiologists. Recent data from the American Society of Anesthesiologists (ASA) Management Closed Claims Project [1] show that the percentage of claims resulting from adverse respiratory events, though on the decline (42% in the 1980s to 32% in the 1990s), continue to constitute a large source of morbidity and mortality in anesthetized patients. In 2005, a closed claims analysis of trends in anesthesia-related death and brain damage between 1975 and 2000 showed that out of all respiratory events (n=503) responsible for death and brain damage, difficult endotracheal intubation (n=115), inadequate oxygenation (n=111) and inadvertent esophageal intubation (n=66) were the top three causes [2].

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients that had undergone or will undergo a surgery under general anesthesia .

Exclusion Criteria:

  • known history of syndromal craniofacial abnormalities (e.g. Down syndrome)
  • previous craniofacial surgery
  • excessive facial hair which significantly obscure facial landmarks
  • cervical spine fractures
  • tracheostomy tube
  • patients who are unable to give consent
  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: NCT01630694

Contacts
Contact: Jacek Wojctzak, M.D., Ph.D. 585-275-0480 jack_wojctzak@urmc.rochester.edu

Locations
United States, New York
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Jacek Wojtczak, M.D., Ph.D.    585-275-0480    jack_wojtczak@urmc.rochester.edu   
Contact: Tammy J Ortiz    585-273-2972    tammy_ortiz@urmc.rochester.edu   
Principal Investigator: Jacek Wojtczak, M.D., Ph.D.         
Principal Investigator: Bo Hu, Ph.D.         
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Jacek Wojtczak, MD University of Rochester
  More Information

No publications provided

Responsible Party: Jacek Wojtczak, Principal investigator, University of Rochester
ClinicalTrials.gov Identifier: NCT01630694     History of Changes
Other Study ID Numbers: RSRB case number: 00032136
Study First Received: August 16, 2011
Last Updated: July 31, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
Difficult airway management
anesthesia
difficult intubation

ClinicalTrials.gov processed this record on October 21, 2014