AnesthesiaNCT05989880
Pilot Feasibility Trial of the SafeLM Supraglottic Airway (SGA)
A study testing SafeLM as a supraglottic airway device with video capability, SafeLM as a supraglottic airway device without video capability and SafeLM as a conduit for intubation using an endotracheal tube with video capability in people with Anesthesia, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to assess the feasibility of SafeLM as a primary airway device and as a conduit for intubation with and without the use of a bougie Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia
- What is being tested?
- SafeLM as a supraglottic airway device with video capability, SafeLM as a supraglottic airway device without video capability and SafeLM as a conduit for intubation using an endotracheal tube with video capability
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2023to 2 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective surgery requiring general anesthesia and airway management using a supraglottic airway device or endotracheal intubation
Who cannot join
- pregnancy
- known or suspected difficult airway management
- history of oropharyngeal or upper airway surgery
- known or suspected airway or respiratory pathology, such as significant obstructive sleep apnea or chronic obstructive pulmonary disease (COPD)
- BMI greater than 40 kg/m2
- unable to undergo intubation via the oral route
Show all 10Show fewer
- known or suspected full stomach or other risk factors for aspiration
- contraindication for the use of neuromuscular blocking agents
- history of significant gastroesophageal reflux disease (GERD)
- Vulnerable populations (cognitively impaired persons, prisoners)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Lauren M Nakazawa, MD, 713-500-6775, Lauren.M.Nakazawa@uth.tmc.edu
Carlos Artime, MD, 713-500-6171, Carlos.Artime@uth.tmc.edu
About this study
Official title: Pilot Feasibility Trial of the SafeLM Supraglottic Airway
The purpose of this study is to assess the feasibility of SafeLM as a primary airway device and as a conduit for intubation with and without the use of a bougie
- Conditions
- Anesthesia
- Being tested
- SafeLM as a supraglottic airway device with video capability, SafeLM as a supraglottic airway device without video capability, SafeLM as a conduit for intubation using an endotracheal tube with video capability, SafeLM as a conduit for intubation using a bougie with video capability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SafeLM as a supraglottic airway device with video capabilityDevice
The device will be inserted using the video capability and used as a primary airway device for the duration of the surgical procedure. Once the device is in place, the cuff will be inflated with the recommended volume of air to ensure an adequate seal around the laryngeal opening. The position of the device will be confirmed by observing the video image of the glottis on the monitor. The adequacy of ventilation and oxygenation will be assessed by monitoring the patient's end-tidal CO2, pulse oximetry, and clinical signs of effective ventilation. Leak and cuff pressure will be assessed. The device will be removed at the end of the surgical procedure or if there are any signs of device malfunction, airway obstruction, or inadequate ventilation.
SafeLM as a supraglottic airway device without video capabilityDevice
The device will be blindly inserted without using the video capability and used as a primary airway device for the duration of the surgical procedure. Once the device is in place, the cuff will be inflated with the recommended volume of air to ensure an adequate seal around the laryngeal opening. The position of the device will be confirmed by observing the video image of the glottis on the monitor. The adequacy of ventilation and oxygenation will be assessed by monitoring the patient's end-tidal CO2, pulse oximetry, and clinical signs of effective ventilation. Leak and cuff pressure will be assessed. The video capability of the device will be used to assess the accuracy of placement after the fact. The device will be removed at the end of the surgical procedure or if there are any signs of device malfunction, airway obstruction, or inadequate ventilation.
SafeLM as a conduit for intubation using an endotracheal tube with video capabilityDevice
The device will be inserted, and an endotracheal tube will be advanced through the device under direct visualization using the video capability of the device. Once the device is in place, the cuff will be inflated with the recommended volume of air to ensure an adequate seal around the laryngeal opening. The endotracheal tube will be introduced through the working channel of the SafeLM under direct visualization using the video capability of the device. The endotracheal tube will be advanced into the trachea, and the position will be confirmed by end-tidal carbon dioxide (EtCO2) detection and chest auscultation. The cuff of the endotracheal tube will be inflated, and mechanical ventilation will be resumed. The SafeLM device will be removed, and the position of the endotracheal tube will be confirmed once again.
SafeLM as a conduit for intubation using a bougie with video capabilityDevice
The device will be inserted. Once the device is in place, the cuff will be inflated with the recommended volume of air to ensure an adequate seal around the laryngeal opening.The position of the device will be confirmed by observing the video image of the glottis on the monitor. The video camera on the SafeLM will be turned on to visualize the vocal cords.A standard airway bougie will be introduced through the working channel of the SafeLM under direct visualization using the video capability of the device.The SafeLM device will be removed, and an appropriately sized endotracheal tube will be advanced into the trachea. If a bougie is not able to be inserted into the tracheal under direct visualization, direct insertion of an endotracheal tube into the trachea will be attempted, followed by flexible scope intubation.
| Study group | Role | What they receive |
|---|---|---|
| SafeLM as a supraglottic airway device with video capability | Experimental | Not described Receives: Device: SafeLM as a supraglottic airway device with video capability |
| SafeLM as a supraglottic airway device without video capability | Experimental | Not described Receives: Device: SafeLM as a supraglottic airway device without video capability |
| SafeLM as a conduit for intubation using an endotracheal tube with video capability | Experimental | Not described Receives: Device: SafeLM as a conduit for intubation using an endotracheal tube with video capability |
| SafeLM as a conduit for intubation using a bougie with video capability | Experimental | Not described Receives: Device: SafeLM as a conduit for intubation using a bougie with video capability |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation success rate
This is assessed by the ability of the SafeLM to achieve adequate oxygenation and ventilation via the respective procedure once the airway device is in place.
Measured: at the time of intubation
Secondary outcomes (5)
Number of insertion attempts required to achieve effective oxygenation and ventilation
Measured: at the time of intubation
Time to insertion
This is measured by the time from opening the mouth to the time of end tidal CO2 on capnography
Measured: at the time of intubation
Subjective ease of insertion of the airway device
Measured: at the time of intubation
Safety of the SafeLM as an SGA
This will be assessed by the number of adverse events such as airway obstruction, aspiration, and hypoxia.
Measured: at the time of intubation
Safety of the SafeLM as a conduit for intubation
This will be assessed by the number of adverse events such as esophageal intubation, bronchial intubation, and hypoxia during the intubation process.
Measured: at the time of intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start19 Sep 2023
- Primary completion2 Oct 2025 (estimated)
- Study completion2 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lauren Nakazawa, The University of Texas Health Science Center, Houston
- Investigators
- Lauren M Nakazawa, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05989880
- Sponsor's protocol ID
- HSC-MS-23-0537
- Status last verified
- Dec 2024
- First submitted
- 24 Jul 2023
- Last updated
- 10 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Feasibility Trial of the SafeLM Supraglottic Airway
- ClinicalTrials.gov ID
- NCT05989880
- Acronym / sponsor ID
- HSC-MS-23-0537
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 19 Sep 2023 (actual)
- Primary completion
- 2 Oct 2025 (estimated)
- Study completion
- 2 Dec 2025 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the feasibility of SafeLM as a primary airway device and as a conduit for intubation with and without the use of a bougie
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SafeLM as a supraglottic airway device with video capability | Experimental | Device: SafeLM as a supraglottic airway device with video capability |
| SafeLM as a supraglottic airway device without video capability | Experimental | Device: SafeLM as a supraglottic airway device without video capability |
| SafeLM as a conduit for intubation using an endotracheal tube with video capability | Experimental | Device: SafeLM as a conduit for intubation using an endotracheal tube with video capability |
| SafeLM as a conduit for intubation using a bougie with video capability | Experimental | Device: SafeLM as a conduit for intubation using a bougie with video capability |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- elective surgery requiring general anesthesia and airway management using a supraglottic airway device or endotracheal intubation
Key exclusion criteria (10 listed)
- pregnancy
- known or suspected difficult airway management
- history of oropharyngeal or upper airway surgery
- known or suspected airway or respiratory pathology, such as significant obstructive sleep apnea or chronic obstructive pulmonary disease (COPD)
- BMI greater than 40 kg/m2
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 |
|---|---|---|
| SafeLM as a supraglottic airway device with video capabilityThe device will be inserted using the video capability and used as a primary airway device for the duration of the surgical procedure. Once the device is in place, the cuff will be inflated with the recommended volume of air to ensure an adequate seal around the laryngeal opening. The position of the device will be confirmed by observing the video image of the glottis on the monitor. The adequacy of ventilation and oxygenation will be assessed by monitoring the patient's end-tidal CO2, pulse oximetry, and clinical signs of effective ventilation. Leak and cuff pressure will be assessed. The device will be removed at the end of the surgical procedure or if there are any signs of device malfunction, airway obstruction, or inadequate ventilation. | Device | SafeLM as a supraglottic airway device with video capability |
| SafeLM as a supraglottic airway device without video capabilityThe device will be blindly inserted without using the video capability and used as a primary airway device for the duration of the surgical procedure. Once the device is in place, the cuff will be inflated with the recommended volume of air to ensure an adequate seal around the laryngeal opening. The position of the device will be confirmed by observing the video image of the glottis on the monitor. The adequacy of ventilation and oxygenation will be assessed by monitoring the patient's end-tidal CO2, pulse oximetry, and clinical signs of effective ventilation. Leak and cuff pressure will be assessed. The video capability of the device will be used to assess the accuracy of placement after the fact. The device will be removed at the end of the surgical procedure or if there are any signs of device malfunction, airway obstruction, or inadequate ventilation. | Device | SafeLM as a supraglottic airway device without video capability |
| SafeLM as a conduit for intubation using an endotracheal tube with video capabilityThe device will be inserted, and an endotracheal tube will be advanced through the device under direct visualization using the video capability of the device. Once the device is in place, the cuff will be inflated with the recommended volume of air to ensure an adequate seal around the laryngeal opening. The endotracheal tube will be introduced through the working channel of the SafeLM under direct visualization using the video capability of the device. The endotracheal tube will be advanced into the trachea, and the position will be confirmed by end-tidal carbon dioxide (EtCO2) detection and chest auscultation. The cuff of the endotracheal tube will be inflated, and mechanical ventilation will be resumed. The SafeLM device will be removed, and the position of the endotracheal tube will be confirmed once again. | Device | SafeLM as a conduit for intubation using an endotracheal tube with video capability |
| SafeLM as a conduit for intubation using a bougie with video capabilityThe device will be inserted. Once the device is in place, the cuff will be inflated with the recommended volume of air to ensure an adequate seal around the laryngeal opening.The position of the device will be confirmed by observing the video image of the glottis on the monitor. The video camera on the SafeLM will be turned on to visualize the vocal cords.A standard airway bougie will be introduced through the working channel of the SafeLM under direct visualization using the video capability of the device.The SafeLM device will be removed, and an appropriately sized endotracheal tube will be advanced into the trachea. If a bougie is not able to be inserted into the tracheal under direct visualization, direct insertion of an endotracheal tube into the trachea will be attempted, followed by flexible scope intubation. | Device | SafeLM as a conduit for intubation using a bougie with video capability |
Primary outcome
Intubation success rate
Time frame: at the time of intubation
This is assessed by the ability of the SafeLM to achieve adequate oxygenation and ventilation via the respective procedure once the airway device is in place.
5 secondary outcomes
Number of insertion attempts required to achieve effective oxygenation and ventilation
Time frame: at the time of intubation
Time to insertion
Time frame: at the time of intubation
Subjective ease of insertion of the airway device
Time frame: at the time of intubation
Safety of the SafeLM as an SGA
Time frame: at the time of intubation
Safety of the SafeLM as a conduit for intubation
Time frame: at the time of intubation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Lauren M Nakazawa, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SafeLM as a supraglottic airway device with video capability, SafeLM as a supraglottic airway device without video capability and SafeLM as a conduit for intubation using an endotracheal tube with video capability in people with Anesthesia, run by The University of Texas Health Science Center, Houston 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 10 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: looking for participants now, as of the sponsor's last update on 10 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lauren M Nakazawa, MD (713-500-6775, Lauren.M.Nakazawa@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intubation success rate (time frame: at the time of intubation). 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 10 Dec 2024.