Three-dimensional Craniofacial Phenotyping of Patients With Difficult Airway

Failed or Difficult Intubation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01630694
• Other study ID #: RSRB case number: 00032136
• Status: Terminated
• Phase: N/A
• First received: August 16, 2011
• Last updated: December 14, 2015
• Start date: July 2010
• Est. completion date: October 2012

Study information

• Verified date: December 2015
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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].

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Failed or Difficult Intubation

Intervention

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.
• 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.
• 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
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No