Airway ManagementSACOVLM-PEDINCT07891832
Video Laryngeal Mask SaCoVLM Versus LMA Supreme and Ambu AuraGain in Children
A study testing SaCoVLM video laryngeal mask, LMA Supreme and Ambu AuraGain in people with Airway Management and Anesthesia, General, run by Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s. at 1 site in Czechia.
Trial summary
This randomised controlled trial compares three supraglottic airway devices (laryngeal masks) in children with a body weight of 3-30 kg undergoing elective surgery under general anaesthesia: the SaCoVLM video laryngeal mask (UE Medical), which has an integrated camera allowing visual confirmation and adjustment of… Read more about this study
- Who is it for?
- Ages 1 month to 10 years
- Conditions the study is for
- Airway Management, Anesthesia, General, Pediatric Anesthesia
- What is being tested?
- SaCoVLM video laryngeal mask, LMA Supreme and Ambu AuraGain
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Nov 2026to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 1 month to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Paediatric patients scheduled for elective surgery under general anaesthesia with a supraglottic airway device
- Body weight 3-30 kg (supraglottic airway device sizes 1-2.5)
- Written informed consent of the parent or legal guardian
Who cannot join
- Body weight < 3 kg or > 30 kg
- Anticipated difficult airway
- History of difficult airway
- Indication for airway management by a method other than a supraglottic airway device
- Emergency surgery
- Absence of written informed consent of the parent or legal guardian
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site
Masaryk Hospital Usti nad Labem, Krajska zdravotni a.s.
Ústí nad Labem, 400 11
About this study
Official title: Oropharyngeal Leak Pressure of the SaCoVLM Video Laryngeal Mask Compared With LMA Supreme and Ambu AuraGain in Paediatric Patients Undergoing General Anaesthesia: A Multicentre Randomised Controlled Trial
This randomised controlled trial compares three supraglottic airway devices (laryngeal masks) in children with a body weight of 3-30 kg undergoing elective surgery under general anaesthesia: the SaCoVLM video laryngeal mask (UE Medical), which has an integrated camera allowing visual confirmation and adjustment of mask position, the LMA Supreme (Teleflex) and the Ambu AuraGain (Ambu). Children are randomly assigned in a 1:1:1 ratio to one of the three devices. The main question is whether the SaCoVLM provides a higher oropharyngeal leak pressure (a measure of how well the mask seals the airway) than the LMA Supreme and the Ambu AuraGain. Secondary questions include first-attempt insertion success, the need for repositioning or reinsertion of the mask during surgery and airway-related complications.
Read the detailed description
Blind insertion of supraglottic airway devices is associated with a first-attempt success rate of about 85% and frequent suboptimal positioning, which may require repositioning or reinsertion and can lead to desaturation, laryngospasm or bronchospasm. The SaCoVLM combines a second-generation laryngeal mask with a video camera that visualises the laryngeal inlet and allows the position to be corrected without reinsertion.
Design: prospective, parallel-group, randomised controlled superiority trial with three arms (SaCoVLM, LMA Supreme, Ambu AuraGain), conducted in accordance with the Declaration of Helsinki and Good Clinical Practice.
Procedures: After confirmation of eligibility, written informed consent of the parent or legal guardian and pre-anaesthetic assessment, participants are randomised 1:1:1 using a computer-generated sequence with variable block sizes (Study Randomizer). Anaesthesia is induced with propofol and sufentanil at the discretion of the attending anaesthesiologist; neuromuscular blocking agents are not administered before device insertion and OLP measurement. Device size follows manufacturer weight-based recommendations; the dorsal surface is lubricated with water-based gel. In the SaCoVLM group, the integrated video display is used to visualise the laryngeal inlet and to verify and, if necessary, adjust the device position. A maximum of three insertion attempts is permitted; failure leads to conversion to tracheal intubation or a different supraglottic airway device. Cuff pressure is set to 40-60 cmH2O using a manual manometer. OLP is measured within 5 minutes after insertion once stable ventilation is achieved (manual mode, ventilation paused, fresh gas flow 10 L/min, APL valve set to 50 cmH2O; the airway pressure at which the manometer reading becomes stable is recorded). In the SaCoVLM group, video image quality (5-point Likert scale) and percentage of glottic opening (POGO) are recorded immediately after OLP measurement. Device function, need for repositioning or reinsertion and complications are recorded during surgery; blood staining is assessed after removal at the end of emergence.
Blinding: the anaesthesiologists inserting the device are not blinded; statistical analysis is performed by investigators blinded to group allocation.
Statistics: The primary hypothesis is tested by two pre-specified pairwise comparisons (SaCoVLM vs LMA Supreme and SaCoVLM vs Ambu AuraGain) using independent-samples t-tests (or Mann-Whitney U test), with Bonferroni-adjusted two-sided alpha of 0.025 per comparison. LMA Supreme vs Ambu AuraGain is reported descriptively. Secondary endpoints are exploratory (chi-square/Fisher exact test, t-test/Mann-Whitney U test). The primary analysis follows the intention-to-treat principle; a per-protocol analysis is a sensitivity analysis.
Sample size: assuming mean OLP of 25 cmH2O (SD 5) for LMA Supreme and 29 cmH2O (SD 5) for SaCoVLM (minimal clinically important difference 4 cmH2O, Cohen's d 0.8), alpha 0.025 and 90% power, 41 evaluable patients per group are required; allowing 10% non-evaluable data, 45 patients per group (135 in total) will be enrolled.
- Conditions
- Airway Management, Anesthesia, General, Pediatric Anesthesia
- Being tested
- SaCoVLM video laryngeal mask, LMA Supreme, Ambu AuraGain
- Keywords
- supraglottic airway device, video laryngeal mask, SaCoVLM, LMA Supreme, Ambu AuraGain, oropharyngeal leak pressure, children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SaCoVLM video laryngeal maskDevice
Airway management with the SaCoVLM video laryngeal mask (UE Medical, China), a second-generation supraglottic airway device with an integrated camera. The video display is used to visualise the laryngeal inlet and to verify and, if necessary, adjust the device position. Size per manufacturer weight-based recommendation; cuff pressure 40-60 cmH2O.
LMA SupremeDevice
Airway management with the LMA Supreme (Teleflex, USA), a second-generation supraglottic airway device inserted using the standard blind technique. Size per manufacturer weight-based recommendation; cuff pressure 40-60 cmH2O.
Ambu AuraGainDevice
Airway management with the Ambu AuraGain (Ambu A/S, Denmark), a second-generation supraglottic airway device inserted using the standard blind technique. Size per manufacturer weight-based recommendation; cuff pressure 40-60 cmH2O.
| Study group | Role | What they receive |
|---|---|---|
| SaCoVLM | Experimental | Children randomised to airway management with the SaCoVLM video laryngeal mask, with video-guided verification and adjustment of device position. Receives: Device: SaCoVLM video laryngeal mask |
| LMA Supreme | Active comparator | Children randomised to airway management with the LMA Supreme, inserted using the standard blind technique. Receives: Device: LMA Supreme |
| Ambu AuraGain | Active comparator | Children randomised to airway management with the Ambu AuraGain, inserted using the standard blind technique. Receives: Device: Ambu AuraGain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oropharyngeal leak pressure (OLP)
Airway pressure (cmH2O) at which the circuit manometer reading becomes stable, measured with the breathing circuit in manual mode, ventilation paused, fresh gas flow 10 L/min and the APL valve set to 50 cmH2O, after stable ventilation is achieved.
Measured: From device insertion up to 5 minutes after insertion
Secondary outcomes (6)
First-attempt insertion success rate
Proportion of patients in whom the device is successfully inserted with adequate ventilation at the first attempt.
Measured: From the start of the first insertion attempt until successful insertion (maximum 3 attempts), up to 10 minutes
Need for device repositioning or reinsertion during surgery
Proportion of patients requiring repositioning, reinsertion of the device or other airway intervention after successful insertion.
Measured: From device insertion until device removal at the end of anaesthesia, up to 5 hours
Incidence of perioperative airway-related complications
Proportion of patients with at least one of: desaturation (SpO2 < 92%), laryngospasm, bronchospasm, aspiration; each complication also reported separately.
Measured: From device insertion until device removal at the end of anaesthesia, up to 5 hours
Blood staining of the device on removal
Proportion of patients with visible blood on the device or in secretions after device removal.
Measured: At device removal at the end of emergence from anaesthesia, up to 5 hours after insertion
Video image quality (SaCoVLM group only)
Quality of the video image of the integrated display rated by the inserting anaesthesiologist on a 5-point Likert scale (1 = worst, 5 = best; image quality only).
Measured: Immediately after OLP measurement, up to 5 minutes after device insertion
Percentage of glottic opening (POGO) (SaCoVLM group only)
Percentage of the glottic opening visible on the integrated video display (0-100%).
Measured: Immediately after OLP measurement, up to 5 minutes after device insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Airway ManagementStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
- Sponsor type
- University, hospital or other
- Collaborators
- Faculty of Health Studies, J. E. Purkyně University in Ústí nad Labem, Charles University, Czech Republic
- Responsible party
- Principal investigator, Michal Kalina, Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
- Investigators
- Michal Kalina, MD, PhD, MBA, Principal investigator, Masaryk Hospital Usti nad Labem, Krajska zdravotni a.s.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07891832
- Sponsor's protocol ID
- SACOVLM-PEDI
- Other IDs
- IGA-KZ-2025-1-4
- Acronym
- SACOVLM-PEDI
- Status last verified
- Oct 2026
- First submitted
- 17 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gao X, Liu JH, Chen CM, Wang Y, Wang ZY, Yan CL, Zuo MZ, Cao Y, Qiao X, Huang YQ, Liu PC, Zhang H, Zhang JQ, Shen JM, Li C, Wang Y, Sun YY, Song JN, Zhang XZ, Zhang YL, Luo XT, Wu LN, Zhang Y, Shi L, Zhang Y, Xue FS, Tian M. Comparison of the supraglottic airway device BlockBusterTM and laryngeal mask airway Supreme in anaesthetised, paralyzed adult patients: a multicenter randomized controlled trial. Expert Rev Med Devices. 2022 Aug;19(8):649-656. doi: 10.1080/17434440.2022.2130048. Epub 2022 Oct 5.
PubMed 36200143Sun Y, Zhang M, Gao X, Gao Z, Zou T, Guo Y, Liu M, Chen L, Zhang X, Liu Y, Feng H, Wang Y. Effect of the new video laryngeal mask airway SaCoVLM on airway management in lateral laparoscopic urological surgery: A single center randomized controlled trial. Sci Rep. 2024 Jan 25;14(1):2132. doi: 10.1038/s41598-024-51856-4.
PubMed 38272937Yan 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 34979936
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oropharyngeal Leak Pressure of the SaCoVLM Video Laryngeal Mask Compared With LMA Supreme and Ambu AuraGain in Paediatric Patients Undergoing General Anaesthesia: A Multicentre Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07891832
- Acronym / sponsor ID
- SACOVLM-PEDI / SACOVLM-PEDI
- Conditions
- Airway Management, Anesthesia, General, Pediatric Anesthesia
- Keywords
- supraglottic airway device, video laryngeal mask, SaCoVLM, LMA Supreme, Ambu AuraGain, oropharyngeal leak pressure, children
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.University, hospital or other
- Collaborators
- Faculty of Health Studies, J. E. Purkyně University in Ústí nad Labem, Charles University, Czech Republic
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 23 Oct 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.
This randomised controlled trial compares three supraglottic airway devices (laryngeal masks) in children with a body weight of 3-30 kg undergoing elective surgery under general anaesthesia: the SaCoVLM video laryngeal mask (UE Medical), which has an integrated camera allowing visual confirmation and adjustment of mask position, the LMA Supreme (Teleflex) and the Ambu AuraGain (Ambu). Children are randomly assigned in a 1:1:1 ratio to one of the three devices. The main question is whether the SaCoVLM provides a higher oropharyngeal leak pressure (a measure of how well the mask seals the airway) than the LMA Supreme and the Ambu AuraGain. Secondary questions include first-attempt insertion success, the need for repositioning or reinsertion of the mask during surgery and airway-related complications.
Detailed description
Blind insertion of supraglottic airway devices is associated with a first-attempt success rate of about 85% and frequent suboptimal positioning, which may require repositioning or reinsertion and can lead to desaturation, laryngospasm or bronchospasm. The SaCoVLM combines a second-generation laryngeal mask with a video camera that visualises the laryngeal inlet and allows the position to be corrected without reinsertion.
Design: prospective, parallel-group, randomised controlled superiority trial with three arms (SaCoVLM, LMA Supreme, Ambu AuraGain), conducted in accordance with the Declaration of Helsinki and Good Clinical Practice.
Procedures: After confirmation of eligibility, written informed consent of the parent or legal guardian and pre-anaesthetic assessment, participants are randomised 1:1:1 using a computer-generated sequence with variable block sizes (Study Randomizer). Anaesthesia is induced with propofol and sufentanil at the discretion of the attending anaesthesiologist; neuromuscular blocking agents are not administered before device insertion and OLP measurement. Device size follows manufacturer weight-based recommendations; the dorsal surface is lubricated with water-based gel. In the SaCoVLM group, the integrated video display is used to visualise the laryngeal inlet and to verify and, if necessary, adjust the device position. A maximum of three insertion attempts is permitted; failure leads to conversion to tracheal intubation or a different supraglottic airway device. Cuff pressure is set to 40-60 cmH2O using a manual manometer. OLP is measured within 5 minutes after insertion once stable ventilation is achieved (manual mode, ventilation paused, fresh gas flow 10 L/min, APL valve set to 50 cmH2O; the airway pressure at which the manometer reading becomes stable is recorded). In the SaCoVLM group, video image quality (5-point Likert scale) and percentage of glottic opening (POGO) are recorded immediately after OLP measurement. Device function, need for repositioning or reinsertion and complications are recorded during surgery; blood staining is assessed after removal at the end of emergence.
Blinding: the anaesthesiologists inserting the device are not blinded; statistical analysis is performed by investigators blinded to group allocation.
Statistics: The primary hypothesis is tested by two pre-specified pairwise comparisons (SaCoVLM vs LMA Supreme and SaCoVLM vs Ambu AuraGain) using independent-samples t-tests (or Mann-Whitney U test), with Bonferroni-adjusted two-sided alpha of 0.025 per comparison. LMA Supreme vs Ambu AuraGain is reported descriptively. Secondary endpoints are exploratory (chi-square/Fisher exact test, t-test/Mann-Whitney U test). The primary analysis follows the intention-to-treat principle; a per-protocol analysis is a sensitivity analysis.
Sample size: assuming mean OLP of 25 cmH2O (SD 5) for LMA Supreme and 29 cmH2O (SD 5) for SaCoVLM (minimal clinically important difference 4 cmH2O, Cohen's d 0.8), alpha 0.025 and 90% power, 41 evaluable patients per group are required; allowing 10% non-evaluable data, 45 patients per group (135 in total) will be enrolled.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SaCoVLM | Experimental | Device: SaCoVLM video laryngeal maskChildren randomised to airway management with the SaCoVLM video laryngeal mask, with video-guided verification and adjustment of device position. |
| LMA Supreme | Active comparator | Device: LMA SupremeChildren randomised to airway management with the LMA Supreme, inserted using the standard blind technique. |
| Ambu AuraGain | Active comparator | Device: Ambu AuraGainChildren randomised to airway management with the Ambu AuraGain, inserted using the standard blind technique. |
Who may qualify
- Ages
- 1 month to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Paediatric patients scheduled for elective surgery under general anaesthesia with a supraglottic airway device
- Body weight 3-30 kg (supraglottic airway device sizes 1-2.5)
- Written informed consent of the parent or legal guardian
Key exclusion criteria (6 listed)
- Body weight < 3 kg or > 30 kg
- Anticipated difficult airway
- History of difficult airway
- Indication for airway management by a method other than a supraglottic airway device
- Emergency surgery
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 video laryngeal maskAirway management with the SaCoVLM video laryngeal mask (UE Medical, China), a second-generation supraglottic airway device with an integrated camera. The video display is used to visualise the laryngeal inlet and to verify and, if necessary, adjust the device position. Size per manufacturer weight-based recommendation; cuff pressure 40-60 cmH2O. | Device | SaCoVLM |
| LMA SupremeAirway management with the LMA Supreme (Teleflex, USA), a second-generation supraglottic airway device inserted using the standard blind technique. Size per manufacturer weight-based recommendation; cuff pressure 40-60 cmH2O. | Device | LMA Supreme |
| Ambu AuraGainAirway management with the Ambu AuraGain (Ambu A/S, Denmark), a second-generation supraglottic airway device inserted using the standard blind technique. Size per manufacturer weight-based recommendation; cuff pressure 40-60 cmH2O. | Device | Ambu AuraGain |
Primary outcome
Oropharyngeal leak pressure (OLP)
Time frame: From device insertion up to 5 minutes after insertion
Airway pressure (cmH2O) at which the circuit manometer reading becomes stable, measured with the breathing circuit in manual mode, ventilation paused, fresh gas flow 10 L/min and the APL valve set to 50 cmH2O, after stable ventilation is achieved.
6 secondary outcomes
First-attempt insertion success rate
Time frame: From the start of the first insertion attempt until successful insertion (maximum 3 attempts), up to 10 minutes
Need for device repositioning or reinsertion during surgery
Time frame: From device insertion until device removal at the end of anaesthesia, up to 5 hours
Incidence of perioperative airway-related complications
Time frame: From device insertion until device removal at the end of anaesthesia, up to 5 hours
Blood staining of the device on removal
Time frame: At device removal at the end of emergence from anaesthesia, up to 5 hours after insertion
Video image quality (SaCoVLM group only)
Time frame: Immediately after OLP measurement, up to 5 minutes after device insertion
Percentage of glottic opening (POGO) (SaCoVLM group only)
Time frame: Immediately after OLP measurement, up to 5 minutes after device insertion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Background: PubMed 36200143Gao X, Liu JH, Chen CM, Wang Y, Wang ZY, Yan CL, Zuo MZ, Cao Y, Qiao X, Huang YQ, Liu PC, Zhang H, Zhang JQ, Shen JM, Li C, Wang Y, Sun YY, Song JN, Zhang XZ, Zhang YL, Luo XT, Wu LN, Zhang Y, Shi L, Zhang Y, Xue FS, Tian M. Comparison of the supraglottic airway device BlockBusterTM and laryngeal mask airway Supreme in anaesthetised, paralyzed adult patients: a multicenter randomized controlled trial. Expert Rev Med Devices. 2022 Aug;19(8):649-656. doi: 10.1080/17434440.2022.2130048. Epub 2022 Oct 5.
- Background: PubMed 38272937Sun Y, Zhang M, Gao X, Gao Z, Zou T, Guo Y, Liu M, Chen L, Zhang X, Liu Y, Feng H, Wang Y. Effect of the new video laryngeal mask airway SaCoVLM on airway management in lateral laparoscopic urological surgery: A single center randomized controlled trial. Sci Rep. 2024 Jan 25;14(1):2132. doi: 10.1038/s41598-024-51856-4.
- Background: 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.
Michal Kalina, MD, PhD, MBA principal investigator
Masaryk Hospital Usti nad Labem, Krajska zdravotni a.s.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SaCoVLM video laryngeal mask, LMA Supreme and Ambu AuraGain in people with Airway Management and Anesthesia, General, run by Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s. at 1 site in Czechia.
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 6 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: opening soon, as of the sponsor's last update on 23 Oct 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 Czechia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michal Kalina, MD, PhD, MBA (+420477111111, michal.kalina@kzcr.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oropharyngeal leak pressure (OLP) (time frame: From device insertion up to 5 minutes after insertion). 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 NCT07891832, which also lists 3 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 23 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.