Viewing Study NCT06396234



Ignite Creation Date: 2024-05-06 @ 8:28 PM
Last Modification Date: 2024-10-26 @ 3:28 PM
Study NCT ID: NCT06396234
Status: WITHDRAWN
Last Update Posted: 2024-05-06
First Post: 2024-04-29

Brief Title: Study Comparing Intubation Via Video Laryngeal Mask Airways VLMAs Versus Video Laryngoscopy
Sponsor: Montefiore Medical Center
Organization: Montefiore Medical Center

Study Overview

Official Title: Pilot Study Comparing Intubation Via Video Laryngeal Mask Airways VLMAs Versus Video Laryngoscopy Efficacy and Patient Outcomes in General Anesthesia Procedures
Status: WITHDRAWN
Status Verified Date: 2024-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Study never approved by the IRB Was not initiated
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: True
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: None