Clinical trial NCT06396234: Study Comparing Intubation Via Video Laryngeal Mask Airways (VLMAs) Versus Video Laryngoscopy
Official title: Pilot Study Comparing Intubation Via Video Laryngeal Mask Airways (VLMAs) Versus Video Laryngoscopy: Efficacy and Patient Outcomes in General Anesthesia Procedures
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Laryngeal Mask Airways
Airway Management
Supraglottic Airways
Video-assisted
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2024-05-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-centered, Randomized, Pilot Study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Successful first-attempt placement rate of VLMA
timeFrame: Intraoperative period, from the beginning of the general anesthesia induction to VLMA placement, up to 30 seconds
measure: Successful first-attempt placement rate of endotracheal intubation via video laryngoscopy
timeFrame: Intraoperative period, from the beginning of the general anesthesia induction to ETT placement, up to 45 seconds
measure: Number of participants with change in mean blood pressure by 20% from baseline mean blood pressure
timeFrame: Perioperative period, from the beginning of the general anesthesia induction to the end of evaluation, up to 1 day
measure: Number of participants with change in heart rate by 20% from baseline heart rate
timeFrame: Perioperative period, from the beginning of the general anesthesia induction to the end of evaluation, up to 1 day
measure: Number of participants change in oxygen saturation by 20% from baseline
timeFrame: Perioperative period, from the beginning of the general anesthesia induction to the end of evaluation, up to 1 day
measure: Incidence of pharyngalgia, bleeding, hoarseness, and dysphagia events
timeFrame: Postoperative period at 1 hour and 24 hours after procedure
Secondary outcomes:
measure: Incidence of postoperative nausea and vomiting (PONV)
timeFrame: Postoperative period, up to one day following procedure
measure: Number of participants with postoperative hypertension by >30% of baseline, requiring treatment
timeFrame: Postoperative period, up to 1 hour
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Irene Osborn, MD
role: PRINCIPAL_INVESTIGATOR
References:
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