Pilot Feasibility Trial of the SafeLM Supraglottic Airway (SGA)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT05989880 |
Recruitment Status :
Recruiting
First Posted : August 14, 2023
Last Update Posted : May 9, 2024
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Anesthesia | Device: SafeLM as a supraglottic airway device with video capability Device: SafeLM as a supraglottic airway device without video capability Device: SafeLM as a conduit for intubation using an endotracheal tube with video capability Device: SafeLM as a conduit for intubation using a bougie with video capability | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Pilot Feasibility Trial of the SafeLM Supraglottic Airway |
Actual Study Start Date : | September 19, 2023 |
Estimated Primary Completion Date : | October 2, 2024 |
Estimated Study Completion Date : | December 2, 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: SafeLM as a supraglottic airway device with video capability |
Device: SafeLM as a supraglottic airway device with video capability
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. |
Experimental: SafeLM as a supraglottic airway device without video capability |
Device: SafeLM as a supraglottic airway device without video capability
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. |
Experimental: SafeLM as a conduit for intubation using an endotracheal tube with video capability |
Device: SafeLM as a conduit for intubation using an endotracheal tube with video capability
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. |
Experimental: SafeLM as a conduit for intubation using a bougie with video capability |
Device: SafeLM as a conduit for intubation using a bougie with video capability
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. |
- 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.
- 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 ]This is measured by the time from opening the mouth to the time of end tidal CO2 on capnography
- 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 ]This will be assessed by the number of adverse events such as airway obstruction, aspiration, and hypoxia.
- Safety of the SafeLM as a conduit for intubation [ Time Frame: at the time of intubation ]This will be assessed by the number of adverse events such as esophageal intubation, bronchial intubation, and hypoxia during the intubation process.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- elective surgery requiring general anesthesia and airway management using a supraglottic airway device or endotracheal intubation
Exclusion Criteria:
- 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
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05989880
Contact: Lauren M Nakazawa, MD | 713-500-6775 | Lauren.M.Nakazawa@uth.tmc.edu | |
Contact: Carlos Artime, MD | 713-500-6171 | Carlos.Artime@uth.tmc.edu |
United States, Texas | |
The University of Texas Health Science Center at Houston | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Lauren M Nakazawa, MD 713-500-6775 Lauren.M.Nakazawa@uth.tmc.edu | |
Contact: Carlos Artime, MD 713-500-6171 Carlos.Artime@uth.tmc.edu |
Principal Investigator: | Lauren M Nakazawa, MD | The University of Texas Health Science Center, Houston |
Responsible Party: | Lauren Nakazawa, Assistant Professor, The University of Texas Health Science Center, Houston |
ClinicalTrials.gov Identifier: | NCT05989880 |
Other Study ID Numbers: |
HSC-MS-23-0537 |
First Posted: | August 14, 2023 Key Record Dates |
Last Update Posted: | May 9, 2024 |
Last Verified: | May 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Product Manufactured in and Exported from the U.S.: | No |