Intubation ComplicationNCT03340207
Novel Airway Device to Aid Endotracheal Intubations
A study testing Pneumaglide in people with Intubation Complication and Intubation;Difficult, run by University at Buffalo at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Intubation Complication, Intubation;Difficult
- What is being tested?
- Pneumaglide
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2017to 25 Aug 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- undergoing ambulatory surgery under general anesthesia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Intubation Complication, Intubation;Difficult
- Being tested
- Pneumaglide
- Keywords
- intubation, anesthesiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PneumaglideDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Pneumaglide | Experimental | After induction of anesthesia Pneumaglide device will be placed in the mouth of the pneumaglide assigned patients. Receives: Device: Pneumaglide |
| non-pneumaglide | No intervention | The patients in non-pneumaglide will not have Pneumaglide insertion prior to intubation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During procedure
Secondary outcomes (3)
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.
Measured: during procedure
Frequency of Lip/Dentition Injury
frequency of lip/dentition injury will be monitored and compared
Measured: 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
Measured: during procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start15 Oct 2017
- Primary completion25 Mar 2019
- Study completion25 Aug 2019
Why it stopped: A longer time to establish the airway. potential safety issue, despite lacking no adverse event.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Intubation ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nader D Nader, University at Buffalo
- Investigators
- Nader D Nader, MD, PhD, Principal investigator, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03340207
- Sponsor's protocol ID
- 1092558
- Status last verified
- Sep 2022
- First submitted
- 8 Nov 2017
- Last updated
- 14 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to make data available to others
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of PneumaGlide: A Novel Airway Device to Aid Endotracheal Intubations for Novice Intubators
- ClinicalTrials.gov ID
- NCT03340207
- Acronym / sponsor ID
- 1092558
- Conditions
- Intubation Complication, Intubation;Difficult
- Keywords
- intubation, anesthesiology
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: A longer time to establish the airway. potential safety issue, despite lacking no adverse event.
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University at BuffaloUniversity, hospital or other
- Study start
- 15 Oct 2017 (actual)
- Primary completion
- 25 Mar 2019 (actual)
- Study completion
- 25 Aug 2019 (actual)
- First posted
- 13 Nov 2017 (actual)
- Results
- Posted 14 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pneumaglide | Experimental | Device: PneumaglideAfter 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- undergoing ambulatory surgery under general anesthesia
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PneumaglideThe 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 | Device | Pneumaglide |
Primary outcome
Time to Intubation
Time frame: 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.
3 secondary outcomes
Oxygen Saturation Drop
Time frame: during procedure
Frequency of Lip/Dentition Injury
Time frame: during procedure
Frequency of Ask for Help and Repeated Intubation Attempt
Time frame: during procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. There is no plan to make data available to others
Related trials for Intubation Complication
Recruiting
Smart Checklist Implementation for Pediatric Tracheal Intubations in the ICU- Multicenter Study
Intubation Complication
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The ED-AWARENESS-2 Trial
Awareness, Mechanical Ventilation
RecruitingObservational study
Cardiovascular History and Hemodynamic Complications After Intubation in ICU
Hemodynamic Complications
Not yet recruiting
Postoperative Pulmonary Complications After Use of Supraglottic Airway Devices and Neuromuscular Blockade
Postoperative Pulmonary Complications
Not yet recruiting
Establish Whether Hyperangulated Videolaryngoscopy (HAVL) Can be Used to Facilitate Tracheal Intubation Effectively and Safely in Unselected Adult Patients; Describe the Population in Whom HAVL Fails to Facilitate Tracheal Intubation Successfully, Identifying Any Contributory Characteristics.
Intubation Skill, Intubation Complications
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nader D Nader, MD, PhD principal investigator
University at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pneumaglide in people with Intubation Complication and Intubation;Difficult, run by University at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Intubation (time frame: During procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2022.