Trial Outcomes & Findings for Three-dimensional Craniofacial Phenotyping of Patients With Difficult Airway (NCT NCT01630694)
NCT ID: NCT01630694
Last Updated: 2016-01-20
Results Overview
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.
TERMINATED
NA
28 participants
end of study approximately one year
2016-01-20
Participant Flow
Recruitment period for this study is from 11-3-2010 to 10-1-2012 done in a medical clinic setting.
Enrollment goal for this study was met so the study was closed.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
16
|
|
Overall Study
COMPLETED
|
12
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Three-dimensional Craniofacial Phenotyping of Patients With Difficult Airway
Baseline characteristics by cohort
| Measure |
Difficult Intubation Patients
n=12 Participants
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.
|
Control
n=16 Participants
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.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=99 Participants
|
16 participants
n=107 Participants
|
28 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: end of study approximately one yearPopulation: 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
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.
Outcome measures
| Measure |
Difficult Intubation Patients
n=6 Participants
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.
|
Control
n=6 Participants
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.
|
|---|---|---|
|
Mean Hyomental Distance Ratio
|
1.14 ratio
Standard Deviation 0.02
|
1.02 ratio
Standard Deviation 0.01
|
SECONDARY outcome
Timeframe: end of study approximately one yearPopulation: 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
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.
Outcome measures
| Measure |
Difficult Intubation Patients
n=6 Participants
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.
|
Control
n=6 Participants
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.
|
|---|---|---|
|
Mean Tongue Volume
|
137 cubic centimeters
Standard Deviation 29
|
168 cubic centimeters
Standard Deviation 34
|
Adverse Events
Difficult Intubation Patients
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place