Three-dimensional Craniofacial Phenotyping of Patients With Difficult Airway

University of Rochester

Status: Terminated

Conditions: Failed or Difficult Intubation

Treatments: Procedure: 3D Laser Scanning of the Head; Procedure: Ultrasound Exam of the Tongue; Procedure: Measurements and Digital Photo's of the head, neck and Mouth

Study type: Interventional

Funder types: Other

Identifiers

NCT01630694

RSRB case number: 00032136

Details and patient eligibility

About

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.

Full 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].

Enrollment: 28 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups, including a placebo group

Difficult intubation patients

Active Comparator group

Description:

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

Treatment:

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

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: 3D Laser Scanning of the Head

Procedure: Ultrasound Exam of the Tongue

Control

Placebo Comparator group

Description:

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

Treatment:

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

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: 3D Laser Scanning of the Head

Procedure: Ultrasound Exam of the Tongue