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study stopped due to not meeting enrollment goal.
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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.
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].
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Difficult intubation patients | Active Comparator | patients who were difficult to intubate during previous anesthetics provided by the staff anesthesiologists. |
|
| Control | Placebo Comparator | The control group will consist of patients with the easy laryngoscopy and intubation, recruited prospectively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacek Wojtczak, MD | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
Enrollment goal for this study was met so the study was closed.
Recruitment period for this study is from 11-3-2010 to 10-1-2012 done in a medical clinic setting.
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| ID | Title | Description |
|---|---|---|
| FG000 | Difficult Intubation Patients | Obese and morbidly obese patients with a large neck circumference. This arm was patients who were difficult to intubate during previous anesthetics provided by the staff anesthesiologists. 3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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. |
|
|
| 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 |
|
|
| 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. |
|
|
| 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.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 | 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. |
|
|
| end of study approximately one year |
| FG001 |
| Control |
Obese and morbidly obese patients with a large neck circumference. The control group will consist of patients with easy laryngoscopy and intubation, recruited prospectively. 3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed. |
| COMPLETED |
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| NOT COMPLETED |
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Males and Females 18 years and older
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| ID | Title | Description |
|---|---|---|
| BG000 | Difficult Intubation Patients | Obese and morbidly obese patients with a large neck circumference. This arm was patients who were difficult to intubate during previous anesthetics provided by the staff anesthesiologists. 3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed. |
| BG001 | Control | Obese and morbidly obese patients with a large neck circumference. The control group will consist of patients with easy laryngoscopy and intubation, recruited prospectively. 3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | only 6 patients in each group were analyzed because the remaining patients were not eligible for analysis based on a review of their electronic medical chart | Posted | Mean | Standard Deviation | ratio | end of study approximately one year |
|
|
| ||||||||||||||||||||||||||||
| 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. | only 6 patients in each group were analyzed because the remaining patients were not eligible for analysis based on a review of their electronic medical chart | Posted | Mean | Standard Deviation | cubic centimeters | end of study approximately one year |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Difficult Intubation Patients | Obese and morbidly obese patients with a large neck circumference. This arm was patients who were difficult to intubate during previous anesthetics provided by the staff anesthesiologists. 3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed. | 0 | 12 | 0 | 12 | ||
| EG001 | Control | Obese and morbidly obese patients with a large neck circumference. The control group will consist of patients with easy laryngoscopy and intubation, recruited prospectively. 3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed. | 0 | 16 | 0 | 16 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jacek Wojtczak | University of Rochester | 585-273-2972 | jacek_wojtczak@urmc.rochester.edu |
| ID | Term |
|---|---|
| D014894 | Weights and Measures |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| >=65 years |
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| Male |
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| Units | Counts |
|---|---|
| Participants |
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