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Three-dimensional Craniofacial Phenotyping of Patients With Difficult Airway

This study has been terminated.
(study stopped due to not meeting enrollment goal.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01630694
First Posted: June 28, 2012
Last Update Posted: January 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jacek Wojtczak, University of Rochester
  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: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Three -Dimensional (3-D) Craniofacial Phenotyping of Patients With Difficult Airway

Further study details as provided by Jacek Wojtczak, University of Rochester:

Primary Outcome Measures:
  • Mean Hyomental Distance Ratio [ Time Frame: end of study approximately one year ]
    A curved low-frequency transducer and a Flex focul 400 ultrasound system were used to visualize the tongue and shadows of the hyoid bone and mandible. Midsagittal and coronal/transverse scans from the ultrasound were analyzed using ImageJ. The hyomental distances in the neutral and heal-extended positions were measured from the upper border of the hyoid bone to the lower border of the mentum. The ratio is defined as the ratio of the hyomental distance at the extreme of head extension to that in the neutral position.


Secondary Outcome Measures:
  • Mean Tongue Volume [ Time Frame: end of study approximately one year ]
    The midsagittal scans were used to measure the cross-sectional area of the tongue. Transverse scans obtained in the midsection of the tongue (at the glossal end of the genioglossus muscle) provided a measure of the tongue width, which was measured between the most distant points on its upper surface. The tongue volume was derived from the multiplication of the midsagittal cross-sectional area by the tongue width.


Enrollment: 28
Study Start Date: July 2010
Study Completion Date: October 2012
Primary Completion Date: October 2012 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01630694


Locations
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Jacek Wojtczak, MD University of Rochester
  More Information

Responsible Party: Jacek Wojtczak, Principal investigator, University of Rochester
ClinicalTrials.gov Identifier: NCT01630694     History of Changes
Other Study ID Numbers: RSRB case number: 00032136
First Submitted: August 16, 2011
First Posted: June 28, 2012
Results First Submitted: November 2, 2015
Results First Posted: January 20, 2016
Last Update Posted: January 20, 2016
Last Verified: December 2015

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