Trial Outcomes & Findings for Novel Airway Device to Aid Endotracheal Intubations (NCT NCT03340207)
NCT ID: NCT03340207
Last Updated: 2022-10-14
Results Overview
After induction of anesthesia PneumaGlide device will be placed in the mouth of the pneumaglide assigned subject. The patients in non-pneumaglide will not have Pneumaglide insertion. Laryngeal grading of the airway difficulty will be determined in both groups and the degree of difficulty will be graded from I-IV based on visibility of the vocal cords. Grade I is full visibility of glottis, grade II is partial visibility of glottis, grade III is when only epiglottis seen, none of glottis seen, and finally grade IV is when neither glottis nor epiglottis seen. Accordingly higher values represent worse grade. The time will be measured using a an electronic timer from the time that the laryngoscope is inserted into the mouth until the trachea is successfully intubated.
TERMINATED
NA
32 participants
During procedure
2022-10-14
Participant Flow
Requiring endotracheal intubation for general anesthesia
Group, age, BMI, Mallampathi class, Pre and post laryngeal grade of the airway, success and the number of attempts to intubate. As the main outcome variable, we collected the time it took to secure the airway. The occurrence of esophageal intubation, gastric aspiration, and injury to the oropharyngeal tissue was also documented.
Participant milestones
| Measure |
Device
A total of 32 patients were randomized. 16 patients were randomized for Pneumoglide (PG).
|
Control
the other 16 were assigned to the control group.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
|
Overall Study
COMPLETED
|
16
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Novel Airway Device to Aid Endotracheal Intubations
Baseline characteristics by cohort
| Measure |
Controls
n=16 Participants
16 patients were randomized to the "No device" group
|
Device
n=16 Participants
16 patients were randomized to the "Pneumoglide" group
|
Total
n=32 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
|
13 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Age, Continuous
|
67.6 years
STANDARD_DEVIATION 8.6 • n=99 Participants
|
65.3 years
STANDARD_DEVIATION 7.8 • n=107 Participants
|
66.7 years
STANDARD_DEVIATION 7.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=99 Participants
|
16 participants
n=107 Participants
|
32 participants
n=206 Participants
|
|
BMI
|
30.0 kg/m^2
STANDARD_DEVIATION 7.6 • n=99 Participants
|
32 kg/m^2
STANDARD_DEVIATION 8.4 • n=107 Participants
|
31 kg/m^2
STANDARD_DEVIATION 7.5 • n=206 Participants
|
|
Mallampathi class
|
16 participants
n=99 Participants
|
13 participants
n=107 Participants
|
29 participants
n=206 Participants
|
|
post laryngeal grade
|
2 units on a scale
n=99 Participants
|
3 units on a scale
n=107 Participants
|
2 units on a scale
n=206 Participants
|
PRIMARY outcome
Timeframe: During procedurePopulation: time to intubate
After induction of anesthesia PneumaGlide device will be placed in the mouth of the pneumaglide assigned subject. The patients in non-pneumaglide will not have Pneumaglide insertion. Laryngeal grading of the airway difficulty will be determined in both groups and the degree of difficulty will be graded from I-IV based on visibility of the vocal cords. Grade I is full visibility of glottis, grade II is partial visibility of glottis, grade III is when only epiglottis seen, none of glottis seen, and finally grade IV is when neither glottis nor epiglottis seen. Accordingly higher values represent worse grade. The time will be measured using a an electronic timer from the time that the laryngoscope is inserted into the mouth until the trachea is successfully intubated.
Outcome measures
| Measure |
Pneumaglide
n=16 Participants
After induction of anesthesia Pneumaglide device will be placed in the mouth of the pneumaglide assigned patients.
Pneumaglide: The device is designed to facilitate intubation and reduce the time to intubation. It works with traditional glidescope to make the process of intubation easier. In this study patients scheduled for surgery and intubation, will be randomized to two groups. The intervention group will be intubated with the help of the pneumaglide. Yet, the other group will receive standard intubation. We aim to evaluate the efficacy of the Pneumaglide to improve the ease of intubation in unskilled clinicians and skilled clinicians during difficult and routine intubations
|
Non-pneumaglide
n=16 Participants
The patients in non-pneumaglide will not have Pneumaglide insertion prior to intubation.
|
|---|---|---|
|
Time to Intubation
|
56 Seconds
Interval 47.0 to 75.0
|
41 Seconds
Interval 37.0 to 48.0
|
SECONDARY outcome
Timeframe: during procedurePopulation: pulseoxymetry
Oxygen Saturation will be monitored throughout the case and any events with oxygen saturation levels \< 90% will be recorded and compared in the two study arms.
Outcome measures
| Measure |
Pneumaglide
n=16 Participants
After induction of anesthesia Pneumaglide device will be placed in the mouth of the pneumaglide assigned patients.
Pneumaglide: The device is designed to facilitate intubation and reduce the time to intubation. It works with traditional glidescope to make the process of intubation easier. In this study patients scheduled for surgery and intubation, will be randomized to two groups. The intervention group will be intubated with the help of the pneumaglide. Yet, the other group will receive standard intubation. We aim to evaluate the efficacy of the Pneumaglide to improve the ease of intubation in unskilled clinicians and skilled clinicians during difficult and routine intubations
|
Non-pneumaglide
n=16 Participants
The patients in non-pneumaglide will not have Pneumaglide insertion prior to intubation.
|
|---|---|---|
|
Oxygen Saturation Drop
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: during procedurefrequency of lip/dentition injury will be monitored and compared
Outcome measures
| Measure |
Pneumaglide
n=16 Participants
After induction of anesthesia Pneumaglide device will be placed in the mouth of the pneumaglide assigned patients.
Pneumaglide: The device is designed to facilitate intubation and reduce the time to intubation. It works with traditional glidescope to make the process of intubation easier. In this study patients scheduled for surgery and intubation, will be randomized to two groups. The intervention group will be intubated with the help of the pneumaglide. Yet, the other group will receive standard intubation. We aim to evaluate the efficacy of the Pneumaglide to improve the ease of intubation in unskilled clinicians and skilled clinicians during difficult and routine intubations
|
Non-pneumaglide
n=16 Participants
The patients in non-pneumaglide will not have Pneumaglide insertion prior to intubation.
|
|---|---|---|
|
Frequency of Lip/Dentition Injury
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: during procedurePopulation: frequency
Frequency of asking for help from seniors and repeated attempts for intubation will be recorded in each group
Outcome measures
| Measure |
Pneumaglide
n=16 Participants
After induction of anesthesia Pneumaglide device will be placed in the mouth of the pneumaglide assigned patients.
Pneumaglide: The device is designed to facilitate intubation and reduce the time to intubation. It works with traditional glidescope to make the process of intubation easier. In this study patients scheduled for surgery and intubation, will be randomized to two groups. The intervention group will be intubated with the help of the pneumaglide. Yet, the other group will receive standard intubation. We aim to evaluate the efficacy of the Pneumaglide to improve the ease of intubation in unskilled clinicians and skilled clinicians during difficult and routine intubations
|
Non-pneumaglide
n=16 Participants
The patients in non-pneumaglide will not have Pneumaglide insertion prior to intubation.
|
|---|---|---|
|
Frequency of Ask for Help and Repeated Intubation Attempt
|
3 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: upon discharge from hospital up to two weeksPopulation: This particular outcome measure reflects the number of the responders to the small questionnaire. While the initial number of the patients were 16 in each group, only 10 from the device group and 8 from the control group opted to respond and were included in the analysis.
questionaire is handed to the patient at the time of their discharge from the Ambulatory Surgery Unit and will accompany a self addressed envelope. The patients will be asked for the presence of 1-cough, 2-shortness of breath, 3-sore through, 4-any unrecognized injury to the lip or mucosa of the mouth. Each answer is on a scale of 1-5 with 1representing minimal and 5 representing extremely severe complaint. Accordingly the score will be between 4-20. The patients will be instructed to complete and mail their questionaire along with their mailing address.
Outcome measures
| Measure |
Pneumaglide
n=10 Participants
After induction of anesthesia Pneumaglide device will be placed in the mouth of the pneumaglide assigned patients.
Pneumaglide: The device is designed to facilitate intubation and reduce the time to intubation. It works with traditional glidescope to make the process of intubation easier. In this study patients scheduled for surgery and intubation, will be randomized to two groups. The intervention group will be intubated with the help of the pneumaglide. Yet, the other group will receive standard intubation. We aim to evaluate the efficacy of the Pneumaglide to improve the ease of intubation in unskilled clinicians and skilled clinicians during difficult and routine intubations
|
Non-pneumaglide
n=8 Participants
The patients in non-pneumaglide will not have Pneumaglide insertion prior to intubation.
|
|---|---|---|
|
Adverse Event Reports by the Patients (Likert Scale)
|
5 total score on a scale 4-20
Interval 4.0 to 7.0
|
5 total score on a scale 4-20
Interval 5.0 to 8.0
|
Adverse Events
Device
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