Three-dimensional Craniofacial Phenotyping of Patients With Difficult Airway

Not Applicable

Terminated

• Conditions: Failed or Difficult Intubation
• Interventions: 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

• Registration Number: NCT01630694
• Lead Sponsor: University of Rochester

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.

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 \[2\].

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2011-08-16
• Study First Submitted QC: 2012-06-26
• Study First Posted: 2012-06-28
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Results First Submitted: 2015-11-02
• Status Verified: 2015-12
• Results First Submitted QC: 2015-12-14
• Last Update Submitted: 2015-12-14
• Results First Posted: 2016-01-20
• Last Update Posted: 2016-01-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Difficult intubation patients	Ultrasound Exam of the Tongue	patients who were difficult to intubate during previous anesthetics provided by the staff anesthesiologists.
Difficult intubation patients	3D Laser Scanning of the Head	patients who were difficult to intubate during previous anesthetics provided by the staff anesthesiologists.
Control	3D Laser Scanning of the Head	The control group will consist of patients with the easy laryngoscopy and intubation, recruited prospectively.
Control	Ultrasound Exam of the Tongue	The control group will consist of patients with the easy laryngoscopy and intubation, recruited prospectively.
Difficult intubation patients	Measurements and Digital Photo's of the head, neck and Mouth	patients who were difficult to intubate during previous anesthetics provided by the staff anesthesiologists.
Control	Measurements and Digital Photo's of the head, neck and Mouth	The control group will consist of patients with the easy laryngoscopy and intubation, recruited prospectively.

Primary Outcome Measures

Name	Time	Method
Mean Hyomental Distance Ratio	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

Name	Time	Method
Mean Tongue Volume	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.

Trial Locations

Locations (1)

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States