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Novel Airway Device to Aid Endotracheal Intubations

Clinical Trial of PneumaGlide: A Novel Airway Device to Aid Endotracheal Intubations for Novice Intubators

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03340207
Enrollment
32
Registered
2017-11-13
Start date
2017-10-15
Completion date
2019-08-25
Last updated
2022-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intubation Complication, Intubation;Difficult

Keywords

intubation, anesthesiology

Brief summary

Pneumaglide is a device designed to facilitate intubation. Patients who are undergoing a surgical procedure under general anesthesia and will require placement of endotracheal tube will be screened and upon fulfilling the inclusion criteria will be randomized to PneumaGlide group or non-PneumaGlide group. After induction of anesthesia PneumaGlide device will placed in the mouth of the Pneumaglide assigned subject. The time for intubation will be measured from the time that the laryngoscope is inserted into the mouth until the trachea is successfully intubated and compared between the groups. Oxygen saturation drop below 90% and also gastric secretion spillage will be compared between two groups as well.

Detailed description

Patients who is undergoing a surgical procedure under general anesthesia and will require placement of endotracheal tube will be screened. If the patient meets the inclusion criteria and does not have any exclusion criteria, after an informed consent is obtained he or she will be randomized to Pneumaglide group or non-Pneumaglide group . Patients characteristics, anthropometric data and comorbid conditions wil be questioned and collected into data collection tool forms. Airway difficulty will be assessed by the range of motion for atlanto axial joint (head flexion and extension), temporomandibular joint (mouth opening), thyromental distance and mallampati classification for visualisation of uvula, tonsillar pillars and soft palate. After induction of anesthesia PneumaGlide device will 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. 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. The spillage of of gastric contents will also be assessed by direct visualization at the time of intubation. 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. All Categorical variables will be analyzed using Fisher's exact test and the numerical values with normal distribution pattern will be analyzed with t-tests and expressed as mean ± standard deviation. Numerical variables in which the normality is rejected will be analyzed using non-parametric test Wilcox Sum Rank and will be expressed as median \[Interquartile Range\]. Upon completion of the surgery, two Likert-based questionaires will be filled out. One questionaire is completed by the person who performed intubation for the ease of use, and the level of comfort during its use. The second 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 cough, shortness of breath, sore through, any unrecognized injury to the lip or mucosa of the mouth. The patients will be instructed to complete and mail their questionaire along with their mailing address.

Interventions

DEVICEPneumaglide

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

Sponsors

University at Buffalo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

\* undergoing ambulatory surgery under general anesthesia

Exclusion criteria

* pregnant patients * parturients with past 60 days, * poorly controlled diabetic patient with neuropathy and HbA1c \> 9.0%, \*preexisting nausea and vomiting, * intestinal obstruction * acute alcohol toxicity

Design outcomes

Primary

MeasureTime frameDescription
Time to IntubationDuring procedureAfter 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.

Secondary

MeasureTime frameDescription
Oxygen Saturation Dropduring procedureOxygen 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.
Frequency of Lip/Dentition Injuryduring procedurefrequency of lip/dentition injury will be monitored and compared
Frequency of Ask for Help and Repeated Intubation Attemptduring procedureFrequency of asking for help from seniors and repeated attempts for intubation will be recorded in each group

Other

MeasureTime frameDescription
Adverse Event Reports by the Patients (Likert Scale)upon discharge from hospital up to two weeksquestionaire 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.

Countries

United States

Participant flow

Recruitment details

Requiring endotracheal intubation for general anesthesia

Pre-assignment details

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.

Participants by arm

ArmCount
Controls
16 patients were randomized to the No device group
16
Device
16 patients were randomized to the Pneumoglide group
16
Total32

Baseline characteristics

CharacteristicTotalControlsDevice
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
4 Participants3 Participants1 Participants
Age, Categorical
Between 18 and 65 years
28 Participants13 Participants15 Participants
Age, Continuous66.7 years
STANDARD_DEVIATION 7
67.6 years
STANDARD_DEVIATION 8.6
65.3 years
STANDARD_DEVIATION 7.8
BMI31 kg/m^2
STANDARD_DEVIATION 7.5
30.0 kg/m^2
STANDARD_DEVIATION 7.6
32 kg/m^2
STANDARD_DEVIATION 8.4
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants1 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
5 Participants2 Participants3 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
26 Participants13 Participants13 Participants
Mallampathi class29 participants16 participants13 participants
post laryngeal grade2 units on a scale2 units on a scale3 units on a scale
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
6 Participants3 Participants3 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants1 Participants0 Participants
Race (NIH/OMB)
White
25 Participants12 Participants13 Participants
Region of Enrollment
United States
32 participants16 participants16 participants
Sex: Female, Male
Female
0 Participants0 Participants0 Participants
Sex: Female, Male
Male
32 Participants16 Participants16 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 160 / 16
other
Total, other adverse events
0 / 160 / 16
serious
Total, serious adverse events
0 / 160 / 16

Outcome results

Primary

Time to Intubation

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.

Time frame: During procedure

Population: time to intubate

ArmMeasureValue (MEDIAN)
PneumaglideTime to Intubation56 Seconds
Non-pneumaglideTime to Intubation41 Seconds
Secondary

Frequency of Ask for Help and Repeated Intubation Attempt

Frequency of asking for help from seniors and repeated attempts for intubation will be recorded in each group

Time frame: during procedure

Population: frequency

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
PneumaglideFrequency of Ask for Help and Repeated Intubation Attempt3 Participants
Non-pneumaglideFrequency of Ask for Help and Repeated Intubation Attempt0 Participants
Secondary

Frequency of Lip/Dentition Injury

frequency of lip/dentition injury will be monitored and compared

Time frame: during procedure

ArmMeasureValue (NUMBER)
PneumaglideFrequency of Lip/Dentition Injury0 participants
Non-pneumaglideFrequency of Lip/Dentition Injury0 participants
Secondary

Oxygen Saturation Drop

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.

Time frame: during procedure

Population: pulseoxymetry

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
PneumaglideOxygen Saturation Drop0 Participants
Non-pneumaglideOxygen Saturation Drop0 Participants
Other Pre-specified

Adverse Event Reports by the Patients (Likert Scale)

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.

Time frame: upon discharge from hospital up to two weeks

Population: 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.

ArmMeasureValue (MEDIAN)
PneumaglideAdverse Event Reports by the Patients (Likert Scale)5 total score on a scale 4-20
Non-pneumaglideAdverse Event Reports by the Patients (Likert Scale)5 total score on a scale 4-20

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026