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

NCT06396234 | Withdrawn FDA Device

• 1 other identifier: 2023-15294
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (6)

• Successful first-attempt placement rate of VLMA

  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

• Successful first-attempt placement rate of endotracheal intubation via video laryngoscopy

  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

  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

  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

  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

  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

Secondary Outcomes (2)

• Incidence of postoperative nausea and vomiting (PONV)

  Postoperative period, up to one day following procedure

• Number of participants with postoperative hypertension by >30% of baseline, requiring treatment

  Postoperative period, up to 1 hour

Study Arms (3)

Safe VLM

EXPERIMENTAL

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

Video laryngoscopy

ACTIVE COMPARATOR

Following anesthetic induction, endotracheal intubation will be performed with a video laryngoscope.

Procedure: Endotracheal intubation using video laryngoscope

SaCo VLM

EXPERIMENTAL

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

Interventions

Safe VLM and airway management DEVICE

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

Also known as: SafeLM® Video Laryngeal Mask System by Magill Medical Technology Co. Ltd

Safe VLM

Endotracheal intubation using video laryngoscope PROCEDURE

Endotracheal intubation (size 7.0 mm) using video laryngoscope

Video laryngoscopy

SaCo VLM and airway management DEVICE

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

Also known as: SaCo (UESCOPE® 2) by UE Medical Devices, Inc.

SaCo VLM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Related Publications (13)

• Gomez-Rios MA, Lopez T, Sastre JA, Gaszynski T, Van Zundert AAJ. Video laryngeal masks in airway management. Expert Rev Med Devices. 2022 Nov;19(11):847-858. doi: 10.1080/17434440.2022.2142558. Epub 2022 Nov 8.

  PMID: 36308748 RESULT

• Gordon J, Cooper RM, Parotto M. Supraglottic airway devices: indications, contraindications and management. Minerva Anestesiol. 2018 Mar;84(3):389-397. doi: 10.23736/S0375-9393.17.12112-7. Epub 2017 Oct 12.

  PMID: 29027772 RESULT

• Hussain D, Kundal R, Kumar A, Sabharwal N. An Analysis of the Comparative Efficacy Between a Third-Generation and a Second-Generation Supraglottic Airway Device in Patients Undergoing Laparoscopic Cholecystectomy. Cureus. 2022 Feb 25;14(2):e22592. doi: 10.7759/cureus.22592. eCollection 2022 Feb.

  PMID: 35355545 RESULT

• Lai CJ, Yeh YC, Tu YK, Cheng YJ, Liu CM, Fan SZ. Comparison of the efficacy of supraglottic airway devices in low-risk adult patients: a network meta-analysis and systematic review. Sci Rep. 2021 Jul 23;11(1):15074. doi: 10.1038/s41598-021-94114-7.

  PMID: 34301986 RESULT

• Sun Y, Huang L, Xu L, Zhang M, Guo Y, Wang Y. The Application of a SaCoVLMTM Visual Intubation Laryngeal Mask for the Management of Difficult Airways in Morbidly Obese Patients: Case Report. Front Med (Lausanne). 2021 Nov 18;8:763103. doi: 10.3389/fmed.2021.763103. eCollection 2021.

  PMID: 34869469 RESULT

• Timmermann A, Bergner UA, Russo SG. Laryngeal mask airway indications: new frontiers for second-generation supraglottic airways. Curr Opin Anaesthesiol. 2015 Dec;28(6):717-26. doi: 10.1097/ACO.0000000000000262.

  PMID: 26539790 RESULT

• Van Zundert AAJ, Gatt SP, Van Zundert TCRV, Kumar CM, Pandit JJ. Features of new vision-incorporated third-generation video laryngeal mask airways. J Clin Monit Comput. 2022 Aug;36(4):921-928. doi: 10.1007/s10877-021-00780-3. Epub 2021 Dec 17.

  PMID: 34919170 RESULT

• Van Zundert AAJ, Kumar CM, Van Zundert TCRV, Gatt SP, Pandit JJ. The case for a 3rd generation supraglottic airway device facilitating direct vision placement. J Clin Monit Comput. 2021 Apr;35(2):217-224. doi: 10.1007/s10877-020-00537-4. Epub 2020 Jun 15.

  PMID: 32537697 RESULT

• van Zundert AAJ, Wyssusek KH, Pelecanos A, Roets M, Kumar CM. A prospective randomized comparison of airway seal using the novel vision-guided insertion of LMA-Supreme(R) and LMA-Protector(R). J Clin Monit Comput. 2020 Apr;34(2):285-294. doi: 10.1007/s10877-019-00301-3. Epub 2019 Apr 5.

  PMID: 30953222 RESULT

• Van Zundert AA, Kumar CM, Van Zundert TC. Malpositioning of supraglottic airway devices: preventive and corrective strategies. Br J Anaesth. 2016 May;116(5):579-82. doi: 10.1093/bja/aew104. No abstract available.

  PMID: 27106958 RESULT

• Yan CL, Zhang YQ, Chen Y, Qv ZY, Zuo MZ. Comparison of SaCoVLM video laryngeal mask-guided intubation and i-gel combined with flexible bronchoscopy-guided intubation in airway management during general anesthesia: a non-inferiority study. BMC Anesthesiol. 2022 Sep 22;22(1):302. doi: 10.1186/s12871-022-01843-x.

  PMID: 36138363 RESULT

• Yan CL, Chen Y, Sun P, Qv ZY, Zuo MZ. Preliminary evaluation of SaCoVLM video laryngeal mask airway in airway management for general anesthesia. BMC Anesthesiol. 2022 Jan 3;22(1):3. doi: 10.1186/s12871-021-01541-0.

  PMID: 34979936 RESULT

• Zhi J, Deng XM, Zhang YM, Wei LX, Wang QY, Yang D. Preliminary evaluation of SaCoVLM video laryngeal mask-guided intubation in airway management for anesthetized children. BMC Anesthesiol. 2023 Feb 8;23(1):49. doi: 10.1186/s12871-023-01996-3.

  PMID: 36755214 RESULT

MeSH Terms

Interventions

Airway Management

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Irene Osborn, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant will have agreed to the study and randomized device or technique will be used.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-centered, Randomized, Pilot Study

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 2, 2024
• Study Start: July 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

US (1)