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A longer time to establish the airway. potential safety issue, despite lacking no adverse event.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pneumaglide | Experimental | After induction of anesthesia Pneumaglide device will be placed in the mouth of the pneumaglide assigned patients. |
|
| non-pneumaglide | No Intervention | The patients in non-pneumaglide will not have Pneumaglide insertion prior to intubation. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pneumaglide | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | during procedure |
| Frequency of Lip/Dentition Injury |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
* undergoing ambulatory surgery under general anesthesia
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nader D Nader, MD, PhD | University at Buffalo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Buffalo VA Medical Center | Buffalo | New York | 14215 | United States |
There is no plan to make data available to others
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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.
Requiring endotracheal intubation for general anesthesia
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| ID | Title | Description |
|---|---|---|
| FG000 | Device | A total of 32 patients were randomized. 16 patients were randomized for Pneumoglide (PG). |
| FG001 | Control | the other 16 were assigned to the control group. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Controls | 16 patients were randomized to the "No device" group |
| BG001 | Device | 16 patients were randomized to the "Pneumoglide" group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Age Category |
| 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 | 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 to intubate | Posted | Median | Inter-Quartile Range | Seconds | During procedure |
|
Two weeks from the time of surgery
lip injury, loss of airway, difficulty in intubation, gastric aspiration
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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 | Device | 16 patients were randomized for Pneumoglide (PG). | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nader D. Nader | VA Western NY Healthcare System | 716-862-8707 | nnader@buffalo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Apr 15, 2019 | Sep 20, 2022 | Prot_SAP_ICF_000.pdf |
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|
frequency of lip/dentition injury will be monitored and compared
| during procedure |
| 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 | during procedure |
| upon discharge from hospital up to two weeks |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Mallampathi class | Number of the participants with Mallampati < Class 3 Mallampati class is used to assess the difficulty of the airway in a scale of 1-4. M1 stands for the easiest access while M4 stand for the most difficult airway. | Number | participants |
|
| post laryngeal grade | The laryngeal view grades are as Grade 1: whole vocal cords are seen, but the epiglottis is not seen. Grade 2: larynx plus the posterior surface of epiglottis are seen. Grade 3: the anterior tip of the epiglottis is seen | Median | Inter-Quartile Range | units on a scale |
|
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
| OG001 | Non-pneumaglide | The patients in non-pneumaglide will not have Pneumaglide insertion prior to intubation. |
|
|
| 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. | pulseoxymetry | Posted | Count of Participants | Participants | during procedure |
|
|
|
| Secondary | Frequency of Lip/Dentition Injury | frequency of lip/dentition injury will be monitored and compared | Posted | Number | participants | during procedure |
|
|
|
| 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 | frequency | Posted | Count of Participants | Participants | during procedure |
|
|
|
| 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. | 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. | Posted | Median | 95% Confidence Interval | total score on a scale 4-20 | upon discharge from hospital up to two weeks |
|
|
|
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Control | 16 were assigned to the control group. | 0 | 16 | 0 | 16 | 0 | 16 |
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