Novel Airway Device to Aid Endotracheal Intubations

NCT03340207 | Terminated Results FDA Device

• 1 other identifier: 1092558
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Intubation Complication; Intubation;Difficult

Keywords

intubation; anesthesiology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Oxygen Saturation Drop

  during procedure

• Frequency of Lip/Dentition Injury

  during procedure

• Frequency of Ask for Help and Repeated Intubation Attempt

  during procedure

Other Outcomes (1)

• Adverse Event Reports by the Patients (Likert Scale)

  upon discharge from hospital up to two weeks

Study Arms (2)

Pneumaglide

EXPERIMENTAL

After induction of anesthesia Pneumaglide device will be placed in the mouth of the pneumaglide assigned patients.

Device: Pneumaglide

non-pneumaglide

NO INTERVENTION

The patients in non-pneumaglide will not have Pneumaglide insertion prior to intubation.

Interventions

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

Pneumaglide

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \* undergoing ambulatory surgery under general anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• University at Buffalo: lead

Study Sites (1)

Buffalo VA Medical Center

Buffalo, New York, 14215, United States

Location

Results Point of Contact

• Title: Dr. Nader D. Nader
• Organization: VA Western NY Healthcare System

nnader@buffalo.edu

716-862-8707

Study Officials

• Nader D Nader, MD, PhD

  University at Buffalo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Senior Vice Chair

Study Record Dates

• First Submitted: November 8, 2017
• First Posted: November 13, 2017
• Study Start: October 15, 2017
• Primary Completion: March 25, 2019
• Study Completion: August 25, 2019
• Last Updated: October 14, 2022
• Results First Posted: October 14, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)