Novel Airway Device to Aid Endotracheal Intubations

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

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.

Study Overview

• Status: Terminated
• Conditions: Intubation Complication; Intubation;Difficult
• Intervention / Treatment: Device: Pneumaglide

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14215
      • Buffalo VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pneumaglide; After induction of anesthesia Pneumaglide device will be placed in the mouth of the pneumaglide assigned patients.	Device: 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
No Intervention: non-pneumaglide; The patients in non-pneumaglide will not have Pneumaglide insertion prior to intubation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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.	upon discharge from hospital up to two weeks

Collaborators and Investigators

• Sponsor: University at Buffalo
• Investigators: Principal Investigator: Nader D Nader, MD, PhD, University at Buffalo

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2017
• Primary Completion (Actual): March 25, 2019
• Study Completion (Actual): August 25, 2019

Study Registration Dates

• First Submitted: November 8, 2017
• First Submitted That Met QC Criteria: November 8, 2017
• First Posted (Actual): November 13, 2017

Study Record Updates

• Last Update Posted (Actual): October 14, 2022
• Last Update Submitted That Met QC Criteria: September 20, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: intubation; anesthesiology
• Other Study ID Numbers: 1092558

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to make data available to others

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes