Three-dimensional Craniofacial Phenotyping of Patients With Difficult Airway

Three -Dimensional (3-D) Craniofacial Phenotyping of Patients With Difficult Airway

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.

Study Overview

• Status: Terminated
• Conditions: Failed or Difficult Intubation
• Intervention / Treatment: 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; Procedure: Measurements and Digital Photo's of the head, neck and Mouth; Procedure: Ultrasound Exam of the Tongue

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].

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: 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 Names: General Electric Total access ultrasound; 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: General Electric Total access ultrasound; 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 Names: 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 Names: General Electric Total Access ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Hyomental Distance Ratio	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.	end of study approximately one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Tongue Volume	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.	end of study approximately one year

Collaborators and Investigators

• Sponsor: University of Rochester
• Investigators: Principal Investigator: Jacek Wojtczak, MD, University of Rochester

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: August 16, 2011
• First Submitted That Met QC Criteria: June 26, 2012
• First Posted (Estimate): June 28, 2012

Study Record Updates

• Last Update Posted (Estimate): January 20, 2016
• Last Update Submitted That Met QC Criteria: December 14, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: anesthesia; difficult intubation; Difficult airway management
• Other Study ID Numbers: RSRB case number: 00032136