Intubation Complication, Intubation;Difficult
Conditions
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
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Time to Intubation | During procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxygen Saturation Drop | during procedure | 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. |
| Frequency of Lip/Dentition Injury | during procedure | frequency of lip/dentition injury will be monitored and compared |
| Frequency of Ask for Help and Repeated Intubation Attempt | during procedure | Frequency of asking for help from seniors and repeated attempts for intubation will be recorded in each group |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse Event Reports by the Patients (Likert Scale) | upon discharge from hospital up to two weeks | 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. |
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
| Arm | Count |
|---|---|
| Controls 16 patients were randomized to the No device group | 16 |
| Device 16 patients were randomized to the Pneumoglide group | 16 |
| Total | 32 |
Baseline characteristics
| Characteristic | Total | Controls | Device |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 3 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants | 13 Participants | 15 Participants |
| Age, Continuous | 66.7 years STANDARD_DEVIATION 7 | 67.6 years STANDARD_DEVIATION 8.6 | 65.3 years STANDARD_DEVIATION 7.8 |
| BMI | 31 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 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 26 Participants | 13 Participants | 13 Participants |
| Mallampathi class | 29 participants | 16 participants | 13 participants |
| post laryngeal grade | 2 units on a scale | 2 units on a scale | 3 units on a scale |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 25 Participants | 12 Participants | 13 Participants |
| Region of Enrollment United States | 32 participants | 16 participants | 16 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 32 Participants | 16 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 16 |
| other Total, other adverse events | 0 / 16 | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 |
Outcome results
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pneumaglide | Time to Intubation | 56 Seconds |
| Non-pneumaglide | Time to Intubation | 41 Seconds |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pneumaglide | Frequency of Ask for Help and Repeated Intubation Attempt | 3 Participants |
| Non-pneumaglide | Frequency of Ask for Help and Repeated Intubation Attempt | 0 Participants |
Frequency of Lip/Dentition Injury
frequency of lip/dentition injury will be monitored and compared
Time frame: during procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pneumaglide | Frequency of Lip/Dentition Injury | 0 participants |
| Non-pneumaglide | Frequency of Lip/Dentition Injury | 0 participants |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pneumaglide | Oxygen Saturation Drop | 0 Participants |
| Non-pneumaglide | Oxygen Saturation Drop | 0 Participants |
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pneumaglide | Adverse Event Reports by the Patients (Likert Scale) | 5 total score on a scale 4-20 |
| Non-pneumaglide | Adverse Event Reports by the Patients (Likert Scale) | 5 total score on a scale 4-20 |