Intubation Complication Clinical Trial
Official title:
Clinical Trial of PneumaGlide: A Novel Airway Device to Aid Endotracheal Intubations for Novice Intubators
Verified date | September 2022 |
Source | University at Buffalo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 32 |
Est. completion date | August 25, 2019 |
Est. primary completion date | March 25, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Buffalo VA Medical Center | Buffalo | New York |
Lead Sponsor | Collaborator |
---|---|
University at Buffalo |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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. | upon discharge from hospital up to two weeks | |
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. | During procedure | |
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. | during procedure | |
Secondary | Frequency of Lip/Dentition Injury | frequency of lip/dentition injury will be monitored and compared | 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 | during procedure |
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