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Study Comparing Intubation Via Video Laryngeal Mask Airways (VLMAs) Versus Video Laryngoscopy

NCT06396234 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-08-09

No results posted yet for this study

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.

Conditions

  • Laryngeal Mask Airways
  • Airway Management
  • Supraglottic Airways
  • Video-assisted

Interventions

DEVICE

Safe VLM and airway management

Once the device is placed, following assessment, endotracheal intubation will be performed via the device.

PROCEDURE

Endotracheal intubation using video laryngoscope

Endotracheal intubation (size 7.0 mm) using video laryngoscope

DEVICE

SaCo VLM and airway management

Once the device is placed, following assessment, endotracheal intubation will be performed via the device.

Sponsors & Collaborators

  • Montefiore Medical Center

    lead OTHER

Principal Investigators

  • Irene Osborn, MD · Montefiore Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-31
Primary Completion
2024-10-31
Completion
2024-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06396234 on ClinicalTrials.gov