An interventional study of Safe VLM and airway management and Endotracheal intubation using video laryngoscope in Laryngeal Mask Airways, Airway Management and Supraglottic Airways, sponsored by Montefiore Medical Center. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-09.
Sponsored by Montefiore Medical Center · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to compare the overall performance and patient outcomes of two video-assisted laryngeal mask airways (VLMAs) devices called Safe and Comfortable (SaCo) VLM and SafeLM® (Safe VLM) versus video laryngoscopy for airway management in adult patients, without an anticipated difficult airway, that are undergoing elective general anesthesia procedures.
The main question it aims to answer is: Can both VLMAs improve patient-centered outcomes in the perioperative and postoperative periods in comparison to endotracheal tube (ETT) intubation? Thirty participants will undergo randomized VLMA with either the Safe VLM (15 participants) or the SaCo VLM (15 participants). And 15 participants will be intubated with ETT using video laryngoscopy, as the control group. Researchers will evaluate the efficacy of these two video-assisted devices in adult patients without an anticipated difficult airway in elective general anesthesia procedures. Other patient outcomes and exploratory endpoints will be recorded as well.
INVESTIGATIONAL DEVICES NAMES SaCo® (UESCOPE® 2) by UE Medical Devices, Inc SafeLM® Video Laryngeal Mask System by Magill Medical Technology Co. Ltd
STUDY RATIONALE New airway devices for anesthesiology are constantly being developed to improve patient overall safety, reduce perioperative risks and complications, enhance recovery, and prevent postoperative adverse-related outcomes. The first and second generation supraglottic airway devices (SADs) have satisfactory features which provide an effective airway and ventilation without the need for more aggressive endotracheal intubation. Nevertheless, these are inserted in a "blind" fashion; malpositioning and potential airway compromise occurs in 50-80% of placements.
Thus, direct vision-guided placement using newer third generation video laryngeal mask airways (VLMAs), can ensure optimal positioning, adequate lung ventilation, and perioperative real-time visualization of the airway. This allows for assessment and any needed corrective maneuvers if they become necessary. The two types of FDA-approved VLMAs that this study will test are: 1) the SafeLM® Video Laryngeal Mask System, which has a camera angle-adjusting handle that allows direct vision up to 140° angle of view of the oropharynx and larynx, with a monitor that is embedded in the device; and 2) the SaCo® Video Laryngeal Mask, which has an embedded camera fixed into the shaft of the device, which attaches to an external monitor. Both devices can guide endotracheal intubation through the ventilation channel under direct vision.
Recent studies have demonstrated the various applications of SaCo VLM for the management of difficult airways in adult patients requiring general anesthesia. This pilot study will be a single-center randomized controlled trial of 45 healthy adult patients undergoing general anesthesia. We aim to explore the efficacy of both VLMAs and evaluate patient perioperative and postoperative outcomes; both are expected to replicate and, possibly, even improve on the outcomes from the conventional video laryngoscopy.
INVESTIGATIONAL DEVICE INTENDED USE The intended use of the video-guided LMAs is to aid in optimal placement of supraglottic airway devices, which will require additional ETT intubation, in participants without anticipated difficult airways.
NUMBER OF SITES One study site: Montefiore Medical Center
SUBJECT POPULATION The two devices will be studied in adult patients, without an anticipated difficult airway, presenting for elective general anesthesia and airway management.
NUMBER OF PARTICIPANTS Thirty participants will undergo supraglottic placement with either the SafeLM (15 participants) or the SaCo VLMAs (15 participants). Fifteen participants will be intubated with ETT via video laryngoscopy, as the control group.
STUDY OBJECTIVE To evaluate the efficacy of the two video-assisted supraglottic devices in elective adult patients without an anticipated difficult airway; other patient outcomes and exploratory endpoints will be recorded as well.
Montefiore Medical Center is the lead sponsor of 402 studies on the registry; 70 are open to participants now.
Of its 81 completed or terminated interventional studies of FDA-regulated products, 73 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The device will be placed after patient is anesthetized. Following placement, the glottis will be observed and endotracheal tube will be placed.
Device: Safe VLM and airway management
Following anesthetic induction, endotracheal intubation will be performed with a video laryngoscope.
Procedure: Endotracheal intubation using video laryngoscope
The device will be placed after patient is anesthetized. Following placement, the glottis will be observed and endotracheal tube will be placed.
Device: SaCo VLM and airway management
Once the device is placed, following assessment, endotracheal intubation will be performed via the device.
Also known as: SafeLM® Video Laryngeal Mask System by Magill Medical Technology Co. Ltd
Endotracheal intubation (size 7.0 mm) using video laryngoscope
Once the device is placed, following assessment, endotracheal intubation will be performed via the device.
Also known as: SaCo (UESCOPE® 2) by UE Medical Devices, Inc.
Successful first-attempt placement rate of VLMA
The first-attempt success rate of VLMA device placement will be determined. Insertion will be considered successful if the VLMA is placed without any resistance and is confirmed to be optimally positioned based on the laryngeal mask visual screen, end-tidal carbon dioxide (CO2) after placement and ventilatory parameters. This will be reported as a dichotomous variable (successful vs unsuccessful).
Time frame: Intraoperative period, from the beginning of the general anesthesia induction to VLMA placement, up to 30 seconds
Successful first-attempt placement rate of endotracheal intubation via video laryngoscopy
Insertion will be considered successful if the endotracheal tube slides through the VLMA without any resistance and is confirmed to be optimally positioned based on observation via the laryngeal mask visual monitor screen and capnography. This will be reported as a dichotomous variable (successful vs unsuccessful).
Time frame: Intraoperative period, from the beginning of the general anesthesia induction to ETT placement, up to 45 seconds
Number of participants with change in mean blood pressure by 20% from baseline mean blood pressure
Measurement of blood pressure will be taken before and after intubation.
Time frame: Perioperative period, from the beginning of the general anesthesia induction to the end of evaluation, up to 1 day
Number of participants with change in heart rate by 20% from baseline heart rate
Measurement of heart rate will be taken before and after intubation.
Time frame: Perioperative period, from the beginning of the general anesthesia induction to the end of evaluation, up to 1 day
Number of participants change in oxygen saturation by 20% from baseline
Measurement of oxygen saturation will be taken before and after intubation.
Time frame: Perioperative period, from the beginning of the general anesthesia induction to the end of evaluation, up to 1 day
Incidence of pharyngalgia, bleeding, hoarseness, and dysphagia events
Incidence of pharyngalgia, bleeding, hoarseness, and dysphagia events will be summarized as observed as reported by patients
Time frame: Postoperative period at 1 hour and 24 hours after procedure
Incidence of postoperative nausea and vomiting (PONV)
Incidence of PONV events will be summarized as observed as reported by patients
Time frame: Postoperative period, up to one day following procedure
Number of participants with postoperative hypertension by >30% of baseline, requiring treatment
Measurement of mean blood pressure will be taken and compared with baseline. If greater than 30%, participants will be given antihypertensive medication. The number/percentage of participants will be summarized
Time frame: Postoperative period, up to 1 hour
Plan to share: Undecided
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Montefiore Medical Center