Three-dimensional Craniofacial Phenotyping of Patients With Difficult Airway

NCT01630694 | Terminated Results

• 1 other identifier: RSRB case number: 00032136
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Failed or Difficult Intubation

Keywords

Difficult airway management; anesthesia; difficult intubation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Mean Tongue Volume

  end of study approximately one year

Study Arms (2)

Difficult intubation patients

ACTIVE COMPARATOR

patients who were difficult to intubate during previous anesthetics provided by the staff anesthesiologists.

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

Control

PLACEBO COMPARATOR

The control group will consist of patients with the easy laryngoscopy and intubation, recruited prospectively.

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

Interventions

3D Laser Scanning of the Head PROCEDURE

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.

Also known as: Konica Minolta 3D Digitizing Konica Minolta 3D laser scanner

Control

Measurements and Digital Photo's of the head, neck and Mouth PROCEDURE

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.

Also known as: General Electric Total access ultrasound

Control

Ultrasound Exam of the Tongue PROCEDURE

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

Also known as: General Electric Total access ultrasound

Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Interventions

Weights and Measures

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

• Title: Jacek Wojtczak
• Organization: University of Rochester

jacek_wojtczak@urmc.rochester.edu

585-273-2972

Study Officials

• Jacek Wojtczak, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 16, 2011
• First Posted: June 28, 2012
• Study Start: July 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: January 20, 2016
• Results First Posted: January 20, 2016

Record last verified: 2015-12

Locations

US (1)