Airway Management, Laryngeal Mask Airways, Supraglottic Airways, Video-assisted
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICESafe VLM and airway management
Once the device is placed, following assessment, endotracheal intubation will be performed via the device.
PROCEDUREEndotracheal intubation using video laryngoscope
Endotracheal intubation (size 7.0 mm) using video laryngoscope
DEVICESaCo VLM and airway management
Once the device is placed, following assessment, endotracheal intubation will be performed via the device.
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participant will have agreed to the study and randomized device or technique will be used.
Intervention model description
Single-centered, Randomized, Pilot Study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Any sex * Age ≥ 18 yrs * BMI ≥ 40 kg/m2 * American Society of Anesthesiologists (ASA) class I-III * With intention to undergo endotracheal intubation * Understanding the purpose of the study and signing the informed consent
Exclusion criteria
* ASA IV * History of upper respiratory infection within 2 weeks * Presence of risk factors for gastric reflux or aspiration * Symptomatic bronchial asthma * Restricted mouth opening (﹤2 cm) * Upper airway tumors, abscesses, foreign bodies or airway stenosis * Requiring one-lung ventilation for thoracic surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of pharyngalgia, bleeding, hoarseness, and dysphagia events | Postoperative period at 1 hour and 24 hours after procedure | Incidence of pharyngalgia, bleeding, hoarseness, and dysphagia events will be summarized as observed as reported by patients |
| Number of participants with change in heart rate by 20% from baseline heart rate | Perioperative period, from the beginning of the general anesthesia induction to the end of evaluation, up to 1 day | Measurement of heart rate will be taken before and after intubation. |
| Number of participants change in oxygen saturation by 20% from baseline | Perioperative period, from the beginning of the general anesthesia induction to the end of evaluation, up to 1 day | Measurement of oxygen saturation will be taken before and after intubation. |
| Successful first-attempt placement rate of VLMA | Intraoperative period, from the beginning of the general anesthesia induction to VLMA placement, up to 30 seconds | 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). |
| Successful first-attempt placement rate of endotracheal intubation via video laryngoscopy | Intraoperative period, from the beginning of the general anesthesia induction to ETT placement, up to 45 seconds | 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). |
| Number of participants with change in mean blood pressure by 20% from baseline mean blood pressure | Perioperative period, from the beginning of the general anesthesia induction to the end of evaluation, up to 1 day | Measurement of blood pressure will be taken before and after intubation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with postoperative hypertension by >30% of baseline, requiring treatment | Postoperative period, up to 1 hour | 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 |
| Incidence of postoperative nausea and vomiting (PONV) | Postoperative period, up to one day following procedure | Incidence of PONV events will be summarized as observed as reported by patients |
Countries
United States
Outcome results
None listed