ObesityNCT07573813
Novel SaCoVLM™ Video Laryngeal Mask Airway as an Intubation Conduit in Morbidly Obese Bariatric Surgery
An observational study of Obesity and Morbidly Obese, run by Yongtao Sun at 1 site in China.
Trial summary
Background: The SaCoVLM™ video laryngeal mask is a novel video-assisted device that integrates the functions of both a dual-channel laryngeal mask airway (LMA) and an intubating laryngeal mask airway (ILMA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Morbidly Obese
- What is being tested?
- SaCoVLM™ in Difficult Airways
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- How many people
- 57 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 30 May 2023
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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
Study population: The study population comprised adult patients aged over 18 years (with no upper age limit) diagnosed with morbid obesity.
Who may be able to join
- Adult patients aged over 18 years (no upper age limit)
- Diagnosed with morbid obesity, clinically defined as either:
- Body mass index (BMI) ≥ 40 kg/m², or BMI ≥ 35 kg/m² accompanied by at least one significant obesity-related comorbidity
Who cannot join
- Have no clinical indicators of anticipated difficult airway (Mallampati classification IV, thyromental distance < 6 cm, mouth opening < 3 cm, severe limited neck extension, or a history of difficult airway management)
- Demonstrate tolerance for laparoscopic surgery and anesthesia
- Be scheduled exclusively for LSG without concurrent additional procedures
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
Jinan, Shandong, 250014
About this study
Official title: Novel SaCoVLM™ Video Laryngeal Mask Airway as an Intubation Conduit in Morbidly Obese Bariatric Surgery: a Single-arm Prospective Study
Background: The SaCoVLM™ video laryngeal mask is a novel video-assisted device that integrates the functions of both a dual-channel laryngeal mask airway (LMA) and an intubating laryngeal mask airway (ILMA). At present, there are relatively few studies on awake airway management for obese patients who undergo laparoscopic sleeve gastrectomy (LSG). To evaluate the efficacy and safety of the SaCoVLM™ video laryngeal mask airway as an intubation conduit in morbidly obese patients undergoing laparoscopic sleeve gastrectomy.
Patients and methods: This single-arm prospective study evaluated the efficacy and safety of the SaCoVLM™ video laryngeal mask airway in 57 morbidly obese patients (BMI ≥35 kg/m²) undergoing LSG.
Read the detailed description
All anesthesiologists in this study underwent centralized training prior to trial initiation, with documented certification in protocol-specific procedures. No preoperative medications were administered to any patients. Upon entering the operating room, patients were positioned in a semi-fowler position, with intravenous access established. Standard monitoring protocols were implemented, including electrocardiography (ECG), heart rate (HR), non-invasive blood pressure (NIBP), pulse oximetry (SpO₂), end-tidal carbon dioxide (EtCO₂), and bispectral index (BIS), alongside radial artery catheterization for invasive blood pressure monitoring. All patients underwent awake insertion of the SaCoVLM™, with surgery completed under general anesthesia combining the video laryngeal mask and endotracheal intubation.
Immediately upon arrival in the operating room, patients were instructed to hold 10 mL of dyclonine mucilage orally for approximately 10 minutes to achieve topical anesthesia. Premedication included midazolam 2 mg and atropine 0.4 mg, followed by bilateral ultrasound-guided superior laryngeal nerve block using 0.375% ropivacaine. A properly sized laryngeal mask was selected, and under awake conditions, patients were instructed to open their mouths to facilitate SaCoVLM™. Optimal positioning was confirmed by visualization of complete glottic structures on the monitor screen. The glottic exposure grade was as we previously described. The cuff was inflated using a handheld manometer, and the mask was connected to the anesthesia machine. Clear glottic visualization on the monitor and the presence of a regular EtCO₂ waveform confirmed proper mask alignment, after which rapid anesthesia induction was initiated.
If suboptimal positioning occurred, the up-down maneuver, cricoid pressure, cuff pressure adjustment, fiberoptic bronchoscopy-guided intubation were applied for minor adjustments. Under direct video guidance, the endotracheal tube was gently advanced along the natural curvature of the airway. Successful intubation was defined by unimpeded tube passage, direct visualization of tracheal entry, and sustained EtCO₂ waveform. Following intubation, the breathing circuit was immediately connected, and bilateral lung auscultation confirmed symmetrical breath sounds before securing both the mask and endotracheal tube. Intraoperative fluid administration and vasoactive medications were adjusted based on vital signs, urine output, and physiological requirements.
Postoperatively, the endotracheal tube was removed under deep anesthesia, and the video laryngeal mask was retained for transfer to the post-anesthesia care unit (PACU). The laryngeal mask was removed only after patients regained adequate spontaneous respiration, demonstrated responsiveness to verbal commands, and met established extubation criteria.
- Conditions
- Obesity, Morbidly Obese
- Being tested
- SaCoVLM™ in Difficult Airways
- Keywords
- Video laryngeal mask airway, Morbidly obese patients, Airway management, Laparoscopic sleeve gastrectomy, First-attempt success rate
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SaCoVLM™ in Difficult AirwaysDevice
As part of the awake airway management protocol initiated in the operating room, patients were first instructed to hold 10 mL of dyclonine mucilage orally for approximately 10 minutes to achieve topical oropharyngeal anesthesia. This was followed by intravenous administration of midazolam 2 mg and atropine 0.4 mg, and bilateral ultrasound-guided superior laryngeal nerve block using 0.375% ropivacaine. A properly sized laryngeal mask was selected. The posterior surface of the cuff was lubricated with a water-based surgical lubricant. Under awake conditions, patients were instructed to open their mouths to facilitate SaCoVLM™ insertion. Optimal positioning was confirmed by visualization of complete glottic structures on the monitor screen. The glottic exposure grade was as we previously described . The cuff was inflated using a handheld manometer, and the mask was connected to the anesthesia machine. Clear glottic visualization on the monitor and the presence of a regular EtCO₂ waveform.
SaCoVLM™ in Difficult AirwaysDevice
As part of the awake airway management protocol initiated in the operating room, patients were first instructed to hold 10 mL of dyclonine mucilage orally for approximately 10 minutes to achieve topical oropharyngeal anesthesia. This was followed by intravenous administration of midazolam 2 mg and atropine 0.4 mg, and bilateral ultrasound-guided superior laryngeal nerve block using 0.375% ropivacaine. A properly sized laryngeal mask was selected. The posterior surface of the cuff was lubricated with a water-based surgical lubricant. Under awake conditions, patients were instructed to open their mouths to facilitate SaCoVLM™ insertion. Optimal positioning was confirmed by visualization of complete glottic structures on the monitor screen. The glottic exposure grade was as we previously described. The cuff was inflated using a handheld manometer, and the mask was connected to the anesthesia machine. Clear glottic visualization on the monitor and the presence of a regular EtCO₂ waveform.
| Study group | Role | What they receive |
|---|---|---|
| morbidly obese bariatric surgery | This study was a single-arm prospective study, so there was no grouping. Receives: Device: SaCoVLM™ in Difficult Airways |
What is being measured
The primary outcome is the main question the study is designed to answer.
the first-time success rate of intubation after insertion of SaCoVLM™
Measured: Within 10 minutes following SaCoVLM™ placement
Secondary outcomes (8)
Time to Successful SaCoVLM™ Insertion (seconds)
Time to successful insertion is measured in seconds as a continuous time-to-event variable. Successful insertion is defined as proper placement of the SaCoVLM™ with visible chest rise and a square-wave capnography trace. Shorter time indicates a better outcome (faster airway establishment). The primary metric reported will be the median insertion time with interquartile range, along with the proportion of successful insertions within 60, 90, and 120 seconds.
Measured: From the start of device insertion into the mouth until the time of successful SaCoVLM™ placement with first confirmed ventilation, assessed up to 120 seconds. If insertion is not successful within 120 seconds, the event is censored at 120 seconds.
Number of SaCoVLM™ Insertion Attempts per Participant
An insertion attempt is defined as any entry of the SaCoVLM™ into the patient's mouth with the intention of placement, regardless of depth or success. Each withdrawal of the device from the mouth followed by re-entry counts as a new attempt. The total number of attempts required to achieve successful placement (confirmed by end-tidal CO₂ waveform) is recorded. Fewer attempts indicate a better outcome (easier insertion). The primary metric reported will be the mean (or median) number of attempts, the range, and the proportion of participants requiring 1, 2, or ≥3 attempts.
Measured: From the first insertion attempt until successful SaCoVLM™ placement is achieved or until the procedure is abandoned, assessed during the initial airway management procedure (up to 120 seconds or a maximum of 3 attempts, whichever comes first).
the SaCoVLM™ glottic exposure grades
Measured: Immediately after SaCoVLM™ placement
Oropharyngeal Leak Pressure (OLP) (cm H₂O)
OLP is measured by closing the adjustable pressure limiting valve of the anesthesia circuit while maintaining a fixed gas flow of 3 L/min. The airway pressure at which an audible leak occurs around the device (or the pressure at which the capnography waveform flattens) is recorded as the OLP in cm H₂O. Higher OLP indicates a better seal and is considered a better outcome (more effective supraglottic airway seal). The primary metric reported will be the mean (or median) OLP with standard deviation or interquartile range.
Measured: Immediately after successful SaCoVLM™ insertion and before start of positive pressure ventilation (measured at a single time point: within 1 minute of confirmation of correct placement)
Proportion of Participants Requiring Any Airway Optimization Maneuver During SaCoVLM™ Placement
The airway optimization protocol includes predefined maneuvers to improve ventilation or seal when SaCoVLM™ placement is suboptimal (e.g., audible leak >30 cm H₂O, absent capnography, or inability to ventilate). Recorded maneuvers may include: chin lift, jaw thrust, head extension/flexion, device rotation, partial withdrawal and reinsertion, or changing to a different size/type of supraglottic airway. The primary outcome metric is the proportion of participants requiring any optimization maneuver during the specified time frame. Secondary metrics include the number of different maneuvers used per participant and the specific maneuvers most frequently applied. No numerical scale is used; this is a descriptive/binary outcome (optimization required: yes/no). Fewer required maneuvers indicate a better outcome (easier device placement).
Measured: During the initial airway management procedure, from the start of the first insertion attempt until successful ventilation is confirmed (assessed up to 120 seconds or a maximum of 3 attempts).
Incidence and Severity of Postoperative Sore Throat (POST) as Assessed by a 4-Point Scale
POST is measured using a 4-point categorical scale:
0 = no sore throat
- = mild sore throat (complains only when asked)
- = moderate sore throat (complains spontaneously)
- = severe sore throat (hoarseness or difficulty swallowing) Minimum value = 0, maximum value = 3. Higher scores indicate a worse outcome (more severe sore throat).
The primary metrics reported will be:
Incidence = proportion of participants with any POST (score ≥1) at the specified time point Severity = mean (or median) score at each time point, plus the proportion with severe POST (score 3)
Measured: At 72 hours after the end of surgery
Incidence and Severity of Postoperative Hoarseness as Assessed by a 4-Point Scale
Postoperative hoarseness is measured using a 4-point categorical scale:
0 = no hoarseness (voice normal)
- = mild hoarseness (voice slightly different but able to speak without difficulty)
- = moderate hoarseness (voice obviously changed, speaking with effort)
- = severe hoarseness (voice barely audible or aphonic)
Measured: At 24 hours after the end of surgery
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Adverse events (AEs) are defined according to [specify system, e.g., Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 or a standardized surgical complication list]. AEs include, but are not limited to: hypoxia, bradycardia, hypotension, laryngospasm, bronchospasm, dental trauma, bleeding, and allergic reaction. Each AE is graded for severity (mild/moderate/severe) and relationship to the procedure. The primary metric reported will be the proportion of participants experiencing at least one AE during the specified time frame. Secondary metrics include the total number of AEs, type and frequency of specific AEs, and proportion of severe AEs. No scale is used for the primary binary outcome; severity grading follows CTCAE (Grade 1-5, where higher grade = worse outcome).
Measured: From the end of surgery until 72 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start1 May 2022
- Primary completion20 May 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Yongtao Sun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yongtao Sun, Qianfoshan Hospital
- Investigators
- Yongtao Sun, Principal investigator, Shandong First Medical UniversityMin Zhang, Study chair, Shandong First Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07573813
- Sponsor's protocol ID
- YXLL-KY-2022 035
- Other IDs
- 320.6750.2024-15-19
- Status last verified
- May 2026
- First submitted
- 6 Apr 2026
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD collected throughout the trial, only IPD used in the results publication
Publications
Harjai M, Alam S, Rastogi S, Kumar S. Effectiveness and Validity of Preoperative Ultrasonographic Airway Assessment and Clinical Screening Tests to Predict Difficult Laryngoscopy: A Prospective, Observational Study. Cureus. 2023 Jul 15;15(7):e41933. doi: 10.7759/cureus.41933. eCollection 2023 Jul.
PubMed 37583718Arterburn DE, Telem DA, Kushner RF, Courcoulas AP. Benefits and Risks of Bariatric Surgery in Adults: A Review. JAMA. 2020 Sep 1;324(9):879-887. doi: 10.1001/jama.2020.12567.
PubMed 32870301Davies MJ, D'Alessio DA, Fradkin J, Kernan WN, Mathieu C, Mingrone G, Rossing P, Tsapas A, Wexler DJ, Buse JB. Management of Hyperglycemia in Type 2 Diabetes, 2018. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2018 Dec;41(12):2669-2701. doi: 10.2337/dci18-0033. Epub 2018 Oct 4.
PubMed 30291106Wang Y, Zhao L, Gao L, Pan A, Xue H. Health policy and public health implications of obesity in China. Lancet Diabetes Endocrinol. 2021 Jul;9(7):446-461. doi: 10.1016/S2213-8587(21)00118-2. Epub 2021 Jun 4.
PubMed 34097869
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel SaCoVLM™ Video Laryngeal Mask Airway as an Intubation Conduit in Morbidly Obese Bariatric Surgery: a Single-arm Prospective Study
- ClinicalTrials.gov ID
- NCT07573813
- Acronym / sponsor ID
- YXLL-KY-2022 035
- Conditions
- Obesity, Morbidly Obese
- Keywords
- Video laryngeal mask airway, Morbidly obese patients, Airway management, Laparoscopic sleeve gastrectomy, First-attempt success rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Yongtao SunUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 20 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 7 May 2026 (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.
Background: The SaCoVLM™ video laryngeal mask is a novel video-assisted device that integrates the functions of both a dual-channel laryngeal mask airway (LMA) and an intubating laryngeal mask airway (ILMA). At present, there are relatively few studies on awake airway management for obese patients who undergo laparoscopic sleeve gastrectomy (LSG). To evaluate the efficacy and safety of the SaCoVLM™ video laryngeal mask airway as an intubation conduit in morbidly obese patients undergoing laparoscopic sleeve gastrectomy.
Patients and methods: This single-arm prospective study evaluated the efficacy and safety of the SaCoVLM™ video laryngeal mask airway in 57 morbidly obese patients (BMI ≥35 kg/m²) undergoing LSG.
Detailed description
All anesthesiologists in this study underwent centralized training prior to trial initiation, with documented certification in protocol-specific procedures. No preoperative medications were administered to any patients. Upon entering the operating room, patients were positioned in a semi-fowler position, with intravenous access established. Standard monitoring protocols were implemented, including electrocardiography (ECG), heart rate (HR), non-invasive blood pressure (NIBP), pulse oximetry (SpO₂), end-tidal carbon dioxide (EtCO₂), and bispectral index (BIS), alongside radial artery catheterization for invasive blood pressure monitoring. All patients underwent awake insertion of the SaCoVLM™, with surgery completed under general anesthesia combining the video laryngeal mask and endotracheal intubation.
Immediately upon arrival in the operating room, patients were instructed to hold 10 mL of dyclonine mucilage orally for approximately 10 minutes to achieve topical anesthesia. Premedication included midazolam 2 mg and atropine 0.4 mg, followed by bilateral ultrasound-guided superior laryngeal nerve block using 0.375% ropivacaine. A properly sized laryngeal mask was selected, and under awake conditions, patients were instructed to open their mouths to facilitate SaCoVLM™. Optimal positioning was confirmed by visualization of complete glottic structures on the monitor screen. The glottic exposure grade was as we previously described. The cuff was inflated using a handheld manometer, and the mask was connected to the anesthesia machine. Clear glottic visualization on the monitor and the presence of a regular EtCO₂ waveform confirmed proper mask alignment, after which rapid anesthesia induction was initiated.
If suboptimal positioning occurred, the up-down maneuver, cricoid pressure, cuff pressure adjustment, fiberoptic bronchoscopy-guided intubation were applied for minor adjustments. Under direct video guidance, the endotracheal tube was gently advanced along the natural curvature of the airway. Successful intubation was defined by unimpeded tube passage, direct visualization of tracheal entry, and sustained EtCO₂ waveform. Following intubation, the breathing circuit was immediately connected, and bilateral lung auscultation confirmed symmetrical breath sounds before securing both the mask and endotracheal tube. Intraoperative fluid administration and vasoactive medications were adjusted based on vital signs, urine output, and physiological requirements.
Postoperatively, the endotracheal tube was removed under deep anesthesia, and the video laryngeal mask was retained for transfer to the post-anesthesia care unit (PACU). The laryngeal mask was removed only after patients regained adequate spontaneous respiration, demonstrated responsiveness to verbal commands, and met established extubation criteria.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| morbidly obese bariatric surgery | – | Device: SaCoVLM™ in Difficult AirwaysThis study was a single-arm prospective study, so there was no grouping. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population comprised adult patients aged over 18 years (with no upper age limit) diagnosed with morbid obesity.
Key inclusion criteria (3 listed)
- Adult patients aged over 18 years (no upper age limit)
- Diagnosed with morbid obesity, clinically defined as either:
- Body mass index (BMI) ≥ 40 kg/m², or BMI ≥ 35 kg/m² accompanied by at least one significant obesity-related comorbidity
Key exclusion criteria (3 listed)
- Have no clinical indicators of anticipated difficult airway (Mallampati classification IV, thyromental distance < 6 cm, mouth opening < 3 cm, severe limited neck extension, or a history of difficult airway management)
- Demonstrate tolerance for laparoscopic surgery and anesthesia
- Be scheduled exclusively for LSG without concurrent additional procedures
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 |
|---|---|---|
| SaCoVLM™ in Difficult AirwaysAs part of the awake airway management protocol initiated in the operating room, patients were first instructed to hold 10 mL of dyclonine mucilage orally for approximately 10 minutes to achieve topical oropharyngeal anesthesia. This was followed by intravenous administration of midazolam 2 mg and atropine 0.4 mg, and bilateral ultrasound-guided superior laryngeal nerve block using 0.375% ropivacaine. A properly sized laryngeal mask was selected. The posterior surface of the cuff was lubricated with a water-based surgical lubricant. Under awake conditions, patients were instructed to open their mouths to facilitate SaCoVLM™ insertion. Optimal positioning was confirmed by visualization of complete glottic structures on the monitor screen. The glottic exposure grade was as we previously described . The cuff was inflated using a handheld manometer, and the mask was connected to the anesthesia machine. Clear glottic visualization on the monitor and the presence of a regular EtCO₂ waveform. | Device | morbidly obese bariatric surgery |
| SaCoVLM™ in Difficult AirwaysAs part of the awake airway management protocol initiated in the operating room, patients were first instructed to hold 10 mL of dyclonine mucilage orally for approximately 10 minutes to achieve topical oropharyngeal anesthesia. This was followed by intravenous administration of midazolam 2 mg and atropine 0.4 mg, and bilateral ultrasound-guided superior laryngeal nerve block using 0.375% ropivacaine. A properly sized laryngeal mask was selected. The posterior surface of the cuff was lubricated with a water-based surgical lubricant. Under awake conditions, patients were instructed to open their mouths to facilitate SaCoVLM™ insertion. Optimal positioning was confirmed by visualization of complete glottic structures on the monitor screen. The glottic exposure grade was as we previously described. The cuff was inflated using a handheld manometer, and the mask was connected to the anesthesia machine. Clear glottic visualization on the monitor and the presence of a regular EtCO₂ waveform. | Device | morbidly obese bariatric surgery |
Primary outcome
the first-time success rate of intubation after insertion of SaCoVLM™
Time frame: Within 10 minutes following SaCoVLM™ placement
8 secondary outcomes
Time to Successful SaCoVLM™ Insertion (seconds)
Time frame: From the start of device insertion into the mouth until the time of successful SaCoVLM™ placement with first confirmed ventilation, assessed up to 120 seconds. If insertion is not successful within 120 seconds, the event is censored at 120 seconds.
Number of SaCoVLM™ Insertion Attempts per Participant
Time frame: From the first insertion attempt until successful SaCoVLM™ placement is achieved or until the procedure is abandoned, assessed during the initial airway management procedure (up to 120 seconds or a maximum of 3 attempts, whichever comes first).
the SaCoVLM™ glottic exposure grades
Time frame: Immediately after SaCoVLM™ placement
Oropharyngeal Leak Pressure (OLP) (cm H₂O)
Time frame: Immediately after successful SaCoVLM™ insertion and before start of positive pressure ventilation (measured at a single time point: within 1 minute of confirmation of correct placement)
Proportion of Participants Requiring Any Airway Optimization Maneuver During SaCoVLM™ Placement
Time frame: During the initial airway management procedure, from the start of the first insertion attempt until successful ventilation is confirmed (assessed up to 120 seconds or a maximum of 3 attempts).
Incidence and Severity of Postoperative Sore Throat (POST) as Assessed by a 4-Point Scale
Time frame: At 72 hours after the end of surgery
Incidence and Severity of Postoperative Hoarseness as Assessed by a 4-Point Scale
Time frame: At 24 hours after the end of surgery
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Time frame: From the end of surgery until 72 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Background: PubMed 37583718Harjai M, Alam S, Rastogi S, Kumar S. Effectiveness and Validity of Preoperative Ultrasonographic Airway Assessment and Clinical Screening Tests to Predict Difficult Laryngoscopy: A Prospective, Observational Study. Cureus. 2023 Jul 15;15(7):e41933. doi: 10.7759/cureus.41933. eCollection 2023 Jul.
- Background: PubMed 32870301Arterburn DE, Telem DA, Kushner RF, Courcoulas AP. Benefits and Risks of Bariatric Surgery in Adults: A Review. JAMA. 2020 Sep 1;324(9):879-887. doi: 10.1001/jama.2020.12567.
- Background: PubMed 30291106Davies MJ, D'Alessio DA, Fradkin J, Kernan WN, Mathieu C, Mingrone G, Rossing P, Tsapas A, Wexler DJ, Buse JB. Management of Hyperglycemia in Type 2 Diabetes, 2018. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2018 Dec;41(12):2669-2701. doi: 10.2337/dci18-0033. Epub 2018 Oct 4.
- Results publication: PubMed 34097869Wang Y, Zhao L, Gao L, Pan A, Xue H. Health policy and public health implications of obesity in China. Lancet Diabetes Endocrinol. 2021 Jul;9(7):446-461. doi: 10.1016/S2213-8587(21)00118-2. Epub 2021 Jun 4.
- Individual participant dataSharing planned: Yes. all IPD collected throughout the trial, only IPD used in the results publication
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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.
Yongtao Sun principal investigator
Shandong First Medical University
Min Zhang study chair
Shandong First Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Morbidly Obese, run by Yongtao Sun at 1 site in China.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 7 May 2026. 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 China. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the first-time success rate of intubation after insertion of SaCoVLM™ (time frame: Within 10 minutes following SaCoVLM™ placement). 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 NCT07573813, which also lists 4 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 7 May 2026.