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

May 2, 2024 updated by: Montefiore Medical Center

Pilot Study Comparing Intubation Via Video Laryngeal Mask Airways (VLMAs) Versus Video Laryngoscopy: Efficacy and Patient Outcomes in General Anesthesia Procedures

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
        • Contact:
        • Principal Investigator:
          • Irene Osborn, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Video laryngoscopy
Following anesthetic induction, endotracheal intubation will be performed with a video laryngoscope.
Procedure: Endotracheal intubation using video laryngoscope
Endotracheal intubation (size 7.0 mm) using video laryngoscope
Experimental: Safe VLM
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
Once the device is placed, following assessment, endotracheal intubation will be performed via the device.
Other Names:
  • SafeLM® Video Laryngeal Mask System by Magill Medical Technology Co. Ltd
Experimental: SaCo VLM
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.
Other Names:
  • SaCo (UESCOPE® 2) by UE Medical Devices, Inc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful first-attempt placement rate of endotracheal intubation via video laryngoscopy
Time Frame: 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).
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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
Postoperative period at 1 hour and 24 hours after procedure
Successful first-attempt placement rate of VLMA
Time Frame: 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).
Intraoperative period, from the beginning of the general anesthesia induction to VLMA placement, up to 30 seconds

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of postoperative nausea and vomiting (PONV)
Time Frame: Postoperative period, up to one day following procedure
Incidence of PONV events will be summarized as observed as reported by patients
Postoperative period, up to one day following procedure
Number of participants with postoperative hypertension by >30% of baseline, requiring treatment
Time Frame: 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
Postoperative period, up to 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Investigators

  • Principal Investigator: Irene Osborn, MD, Montefiore Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

April 29, 2024

First Submitted That Met QC Criteria

April 29, 2024

First Posted (Actual)

May 2, 2024

Study Record Updates

Last Update Posted (Actual)

May 6, 2024

Last Update Submitted That Met QC Criteria

May 2, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2023-15294

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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