Laryngeal Mask AirwaysNCT06396234
Study Comparing Intubation Via Video Laryngeal Mask Airways (VLMAs) Versus Video Laryngoscopy
A study testing Safe VLM and airway management, Endotracheal intubation using video laryngoscope and SaCo VLM and airway management in people with Laryngeal Mask Airways and Airway Management, run by Montefiore Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laryngeal Mask Airways, Airway Management, Supraglottic Airways
- What is being tested?
- Safe VLM and airway management, Endotracheal intubation using video laryngoscope and SaCo VLM and airway management
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2024to Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: 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.
Read the 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.
- Being tested
- Safe VLM and airway management, Endotracheal intubation using video laryngoscope, SaCo VLM and airway management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safe VLM and airway managementDevice
Also called SafeLM® Video Laryngeal Mask System by Magill Medical Technology Co. Ltd
Once the device is placed, following assessment, endotracheal intubation will be performed via the device.
Endotracheal intubation using video laryngoscopeProcedure or surgery
Endotracheal intubation (size 7.0 mm) using video laryngoscope
SaCo VLM and airway managementDevice
Also called SaCo (UESCOPE® 2) by UE Medical Devices, Inc.
Once the device is placed, following assessment, endotracheal intubation will be performed via the device.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Safe VLM and airway management |
| Video laryngoscopy | Active comparator | Following anesthetic induction, endotracheal intubation will be performed with a video laryngoscope. Receives: 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. Receives: Device: SaCo VLM and airway management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Postoperative period at 1 hour and 24 hours after procedure
Secondary outcomes (2)
Incidence of postoperative nausea and vomiting (PONV)
Incidence of PONV events will be summarized as observed as reported by patients
Measured: Postoperative period, up to one day following procedure
Number of participants with postoperative hypertension by >30% of baseline, requiring treatment
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
Measured: Postoperative period, up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study startJul 2024 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Why it stopped: Study never approved by the IRB. Was not initiated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Laryngeal Mask AirwaysStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-centered, Randomized, Pilot Study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Irene Osborn, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06396234
- Sponsor's protocol ID
- 2023-15294
- Other IDs
- 2023
- Status last verified
- Aug 2024
- First submitted
- 29 Apr 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 36308748Gordon 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.
PubMed 29027772Hussain 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.
PubMed 35355545Lai 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.
PubMed 34301986Sun 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.
PubMed 34869469Timmermann 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.
PubMed 26539790Van 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.
PubMed 34919170Van 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.
PubMed 32537697van 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.
PubMed 30953222Van 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.
PubMed 27106958Yan 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.
PubMed 36138363Yan 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.
PubMed 34979936Zhi 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.
PubMed 36755214
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Comparing Intubation Via Video Laryngeal Mask Airways (VLMAs) Versus Video Laryngoscopy: Efficacy and Patient Outcomes in General Anesthesia Procedures
- ClinicalTrials.gov ID
- NCT06396234
- Acronym / sponsor ID
- 2023-15294
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never approved by the IRB. Was not initiated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 2 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Single-centered, Randomized, Pilot Study
| Arm | Type | Receives |
|---|---|---|
| Safe VLM | Experimental | Device: Safe VLM and airway managementThe device will be placed after patient is anesthetized. Following placement, the glottis will be observed and endotracheal tube will be placed. |
| Video laryngoscopy | Active comparator | Procedure: Endotracheal intubation using video laryngoscopeFollowing anesthetic induction, endotracheal intubation will be performed with a video laryngoscope. |
| SaCo VLM | Experimental | Device: SaCo VLM and airway managementThe device will be placed after patient is anesthetized. Following placement, the glottis will be observed and endotracheal tube will be placed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Any sex
- Age ≥ 18 yrs
- BMI ≥ 40 kg/m2
- American Society of Anesthesiologists (ASA) class I-III
- With intention to undergo endotracheal intubation
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Safe VLM and airway managementAlso: SafeLM® Video Laryngeal Mask System by Magill Medical Technology Co. LtdOnce the device is placed, following assessment, endotracheal intubation will be performed via the device. | Device | Safe VLM |
| Endotracheal intubation using video laryngoscopeEndotracheal intubation (size 7.0 mm) using video laryngoscope | Procedure or surgery | Video laryngoscopy |
| SaCo VLM and airway managementAlso: SaCo (UESCOPE® 2) by UE Medical Devices, Inc.Once the device is placed, following assessment, endotracheal intubation will be performed via the device. | Device | SaCo VLM |
Primary outcome
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).
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).
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.
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.
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.
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
2 secondary outcomes
Incidence of postoperative nausea and vomiting (PONV)
Time frame: 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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Results publication: PubMed 36308748Gomez-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.
- Results publication: PubMed 29027772Gordon 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.
- Results publication: PubMed 35355545Hussain 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.
- Results publication: PubMed 34301986Lai 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.
- Results publication: PubMed 34869469Sun 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.
- Results publication: PubMed 26539790Timmermann 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.
- Results publication: PubMed 34919170Van 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.
- Results publication: PubMed 32537697Van 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.
- Results publication: PubMed 30953222van 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.
- Results publication: PubMed 27106958Van 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.
- Results publication: PubMed 36138363Yan 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.
- Results publication: PubMed 34979936Yan 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irene Osborn, MD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Safe VLM and airway management, Endotracheal intubation using video laryngoscope and SaCo VLM and airway management in people with Laryngeal Mask Airways and Airway Management, run by Montefiore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06396234, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.