Anesthesia, GeneralCUFFSTRESSNCT07868848
Effect of Laryngeal Mask Cuff Shape on Pharyngeal Stress
A study testing SaCoVLM video laryngeal mask, LMA Supreme and Ambu AuraGain in people with Anesthesia, General and Airway Management, run by Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s. at 2 sites in Czechia.
Trial summary
Laryngeal masks are widely used supraglottic airway devices, but their cuffs differ considerably in shape and design. The cuff exerts pressure on the pharyngeal structures, which may provoke a physiological stress response and contribute to postoperative pharyngeal complaints. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anesthesia, General, Airway Management, Postoperative Sore Throat
- 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
- 162 participants
- Where
- 2 sitesCzechia
- Study dates
- 1 Oct 2026to 31 Jan 2028
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years
- ASA physical status I-II
- Scheduled for elective surgery under general anaesthesia with a laryngeal mask airway indicated
- No history or predictors of difficult airway
- Signed informed consent
Who cannot join
- Refusal to sign informed consent
- ASA physical status III or higher
- Emergency surgery
- Laparoscopic surgery
- Surgery in the prone position
- Head and neck surgery
- Increased risk of pulmonary aspiration (e.g. gastro-oesophageal reflux disease, body mass index > 35 kg/m2)
- Pre-existing sore throat, hoarseness or upper respiratory tract infection within the preceding 2 weeks
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia2 sites
Nemocnice Decin, Krajska Zdravotni a.s.
Děčín, Ústí nad Labem Region, 405 99
Michal Kalina, MD, Ph.D., MBA, +420773628756, michal.kalina@kzcr.eu
Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
Ústí nad Labem, Ústí nad Labem Region, 401 13
Michal Kalina, MD, Ph.D., MBA, +420773628756, michal.kalina@kzcr.eu
About this study
Official title: Does the Shape of the Laryngeal Mask Airway Cuff Influence Pharyngeal Stress and the Haemodynamic Stress Response? A Prospective Randomized Three-Arm Trial
Laryngeal masks are widely used supraglottic airway devices, but their cuffs differ considerably in shape and design. The cuff exerts pressure on the pharyngeal structures, which may provoke a physiological stress response and contribute to postoperative pharyngeal complaints. This prospective, randomized, two-centre trial compares three commercially available laryngeal masks with different cuff designs (SaCoVLM, LMA Supreme and Ambu AuraGain) in 162 adult patients undergoing elective surgery under general anaesthesia. Anaesthesia induction is standardized and guided by State Entropy, and cuff pressure is standardized to 40-50 cmH2O in all groups. The primary outcome is the change in mean arterial pressure after laryngeal mask insertion. Secondary outcomes include heart rate, nociception and depth-of-anaesthesia indices (Surgical Pleth Index, Response Entropy - State Entropy difference), insertion characteristics, oropharyngeal leak pressure and postoperative pharyngolaryngeal complaints up to 24 hours. The hypothesis is that cuff shape modifies the stress exerted on the pharynx and thereby influences the patient's stress response.
Read the detailed description
Design: prospective, randomized, controlled, parallel-group (1:1:1), two-centre trial (Masaryk Hospital Usti nad Labem and Decin Hospital, Krajska zdravotni, a.s., Czech Republic). Allocation is based on a computer-generated randomization sequence.
Participants: 162 adult patients (ASA physical status I-II) scheduled for elective surgery under general anaesthesia with a laryngeal mask airway, randomized to SaCoVLM, LMA Supreme or Ambu AuraGain (54 patients per group).
Blinding: patients (anaesthetized during device insertion) and outcome assessors in the post-anaesthesia care unit and at the 24-hour follow-up are blinded to group allocation. The anaesthesiologist inserting the device cannot be blinded because the devices are visibly different.
Investigators: all devices are inserted by board-certified anaesthesiologists with at least 5 years of practice and more than 4,000 documented general anaesthetics.
Anaesthesia protocol: standardized induction with sufentanil 0.3 ug/kg ideal body weight and propofol up to 3 mg/kg titrated to a State Entropy of 40-60. Depth of anaesthesia is maintained at a State Entropy of 40-60. No neuromuscular blocking agents are administered before or during the haemodynamic measurement period; they may be used later during surgery if required. Device size is selected according to the manufacturer's recommendations. After insertion, cuff pressure is measured with a manometer and adjusted to 40-50 cmH2O, below the manufacturers' maximum recommended pressure of 60 cmH2O.
Measurements: mean arterial pressure, heart rate, Surgical Pleth Index (SPI), State Entropy (SE) and Response Entropy (RE) are recorded before laryngeal mask insertion (baseline, at SE 40-60), immediately after insertion, and 5 and 10 minutes after insertion. The number of insertion attempts, need for airway manipulation and oropharyngeal leak pressure are recorded. After device removal, sore throat (VAS), hoarseness, blood staining of the device, coughing and postoperative nausea and vomiting are assessed until discharge from the post-anaesthesia care unit and at 24 hours.
Sample size: a between-group difference of 10% of baseline mean arterial pressure (MAP; approximately 8.2 mmHg at a baseline of 82 mmHg) was considered clinically relevant. The standard deviation of MAP after laryngeal mask insertion was estimated at 12 mmHg, derived from the systolic and diastolic blood pressures reported 5 minutes after LMA Supreme insertion (Iran Red Crescent Med J, doi:10.5812/ircmj.28615) and consistent with the MAP variability reported by Montazari et al. (Acta Med Iran 2004;42:437-440). With a two-sided alpha of 0.0167 (Bonferroni correction for three pairwise comparisons) and 80% power, 47 patients per group are required; allowing for a 10% drop-out rate, 54 patients per group (162 in total) will be enrolled.
- Being tested
- SaCoVLM video laryngeal mask, LMA Supreme, Ambu AuraGain
- Keywords
- laryngeal mask airway, supraglottic airway device, cuff design, haemodynamic response, pharyngeal morbidity, SaCoVLM, LMA Supreme, Ambu AuraGain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SaCoVLM video laryngeal maskDevice
Airway secured with the SaCoVLM video laryngeal mask (second-generation supraglottic airway device with integrated video channel), inserted after induction of general anaesthesia according to the manufacturer's instructions.
LMA SupremeDevice
Airway secured with the LMA Supreme (second-generation supraglottic airway device), inserted after induction of general anaesthesia according to the manufacturer's instructions.
Ambu AuraGainDevice
Airway secured with the Ambu AuraGain (second-generation supraglottic airway device), inserted after induction of general anaesthesia according to the manufacturer's instructions.
| Study group | Role | What they receive |
|---|---|---|
| SaCoVLM | Active comparator | Patients in whom the airway is secured with the SaCoVLM video laryngeal mask; cuff pressure adjusted to 40-50 cmH2O (n = 54). Receives: Device: SaCoVLM video laryngeal mask |
| LMA Supreme | Active comparator | Patients in whom the airway is secured with the LMA Supreme; cuff pressure adjusted to 40-50 cmH2O (n = 54). Receives: Device: LMA Supreme |
| Ambu AuraGain | Active comparator | Patients in whom the airway is secured with the Ambu AuraGain; cuff pressure adjusted to 40-50 cmH2O (n = 54). Receives: Device: Ambu AuraGain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Percentage Change in Mean Arterial Pressure From Baseline
Haemodynamic stress response to laryngeal mask insertion: maximum percentage change in mean arterial pressure (MAP) from the pre-insertion baseline value (measured under standardized anaesthesia at State Entropy 40-60) across the post-insertion measurement points. A between-group difference of 10% of baseline MAP is considered clinically relevant.
Measured: Baseline (before laryngeal mask insertion), immediately after insertion, and 5 and 10 minutes after insertion
Secondary outcomes (12)
Postoperative Sore Throat Intensity
Intensity of sore throat assessed by the patient on a visual analogue scale (VAS, 0-100 mm; 0 = no pain, 100 = worst imaginable pain).
Measured: At discharge from the post-anaesthesia care unit (PACU) and 24 hours after laryngeal mask removal
Incidence of Postoperative Sore Throat
Presence of sore throat reported by the patient (yes/no).
Measured: At discharge from the post-anaesthesia care unit (PACU) and 24 hours after laryngeal mask removal
Change in Heart Rate From Baseline
Heart rate (beats/min) as a marker of the haemodynamic stress response to laryngeal mask insertion; change from the pre-insertion baseline value.
Measured: Baseline (before laryngeal mask insertion), immediately after insertion, and 5 and 10 minutes after insertion
Incidence of Hoarseness
Presence of hoarseness (yes/no).
Measured: At discharge from the post-anaesthesia care unit (PACU) and 24 hours after laryngeal mask removal
Blood Staining on the Laryngeal Mask
Presence of visible blood on the laryngeal mask at removal (yes/no).
Measured: At laryngeal mask removal up to 10 minutes from the removal
Coughing at Laryngeal Mask Removal
Coughing assessed with a coughing score (0 = none, 1 = mild, 2 = moderate, 3 = severe).
Measured: At laryngeal mask removal up to 10 minutes from the removal
Incidence of Postoperative Nausea and Vomiting (PONV)
Presence of postoperative nausea and/or vomiting (yes/no).
Measured: At discharge from the post-anaesthesia care unit (PACU) and 24 hours after laryngeal mask removal
Change in Surgical Pleth Index (SPI) From Baseline
Surgical Pleth Index (0-100) as an index of the nociceptive response to laryngeal mask insertion; change from the pre-insertion baseline value.
Measured: Baseline (before laryngeal mask insertion), immediately after insertion, and 5 and 10 minutes after insertion
Change in the Response Entropy - State Entropy Difference From Baseline
Difference between Response Entropy (RE) and State Entropy (SE) as an index of frontal EMG activation in response to laryngeal mask insertion; change from the pre-insertion baseline value.
Measured: Baseline (before laryngeal mask insertion), immediately after insertion, and 5 and 10 minutes after insertion
Number of Insertion Attempts
Number of attempts needed for successful laryngeal mask insertion.
Measured: During laryngeal mask insertion
Need for Airway Manipulation
Need for any additional airway manoeuvre (e.g. jaw thrust, head/neck repositioning, device repositioning or change of size) to achieve adequate ventilation (yes/no).
Measured: From laryngeal mask insertion until 10 minutes after insertion
Oropharyngeal Leak Pressure
Oropharyngeal leak pressure (cmH2O) measured after laryngeal mask insertion with cuff pressure adjusted to 40-50 cmH2O.
Measured: After laryngeal mask insertion and cuff pressure adjustment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, GeneralStudies 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
- Model description
- Two-centre, three parallel groups with 1:1:1 computer-generated random allocation to one of three laryngeal masks (SaCoVLM, LMA Supreme, Ambu AuraGain).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
- Sponsor type
- University, hospital or other
- Collaborators
- Jan Evangelista Purkyne University in Usti nad Labem, Faculty of Health Studies
- Responsible party
- Principal investigator, Michal Kalina, Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
- Investigators
- Michal Kalina, MD, Ph.D., MBA, Principal investigator, Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07868848
- Sponsor's protocol ID
- CUFFSTRESS
- Acronym
- CUFFSTRESS
- Status last verified
- Oct 2026
- First submitted
- 28 Sep 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jarineshin H, Kashani S, Vatankhah M, Abdulahzade Baghaee A, Sattari S, Fekrat F. Better Hemodynamic Profile of Laryngeal Mask Airway Insertion Compared to Laryngoscopy and Tracheal Intubation. Iran Red Crescent Med J. 2015 Aug 12;17(8):e28615. doi: 10.5812/ircmj.28615. eCollection 2015 Aug.
PubMed 26430529Montazari K, Naghibi Kh, Hashemi SJ. Comparison of hemodynamic changes after insertion of laryngeal mask airway, facemask and endotracheal intubation. Acta Med Iran. 2004;42(6):437-440.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Shape of the Laryngeal Mask Airway Cuff Influence Pharyngeal Stress and the Haemodynamic Stress Response? A Prospective Randomized Three-Arm Trial
- ClinicalTrials.gov ID
- NCT07868848
- Acronym / sponsor ID
- CUFFSTRESS / CUFFSTRESS
- Keywords
- laryngeal mask airway, supraglottic airway device, cuff design, haemodynamic response, pharyngeal morbidity, SaCoVLM, LMA Supreme, Ambu AuraGain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.University, hospital or other
- Collaborators
- Jan Evangelista Purkyne University in Usti nad Labem, Faculty of Health Studies
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 9 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.
Laryngeal masks are widely used supraglottic airway devices, but their cuffs differ considerably in shape and design. The cuff exerts pressure on the pharyngeal structures, which may provoke a physiological stress response and contribute to postoperative pharyngeal complaints. This prospective, randomized, two-centre trial compares three commercially available laryngeal masks with different cuff designs (SaCoVLM, LMA Supreme and Ambu AuraGain) in 162 adult patients undergoing elective surgery under general anaesthesia. Anaesthesia induction is standardized and guided by State Entropy, and cuff pressure is standardized to 40-50 cmH2O in all groups. The primary outcome is the change in mean arterial pressure after laryngeal mask insertion. Secondary outcomes include heart rate, nociception and depth-of-anaesthesia indices (Surgical Pleth Index, Response Entropy - State Entropy difference), insertion characteristics, oropharyngeal leak pressure and postoperative pharyngolaryngeal complaints up to 24 hours. The hypothesis is that cuff shape modifies the stress exerted on the pharynx and thereby influences the patient's stress response.
Detailed description
Design: prospective, randomized, controlled, parallel-group (1:1:1), two-centre trial (Masaryk Hospital Usti nad Labem and Decin Hospital, Krajska zdravotni, a.s., Czech Republic). Allocation is based on a computer-generated randomization sequence.
Participants: 162 adult patients (ASA physical status I-II) scheduled for elective surgery under general anaesthesia with a laryngeal mask airway, randomized to SaCoVLM, LMA Supreme or Ambu AuraGain (54 patients per group).
Blinding: patients (anaesthetized during device insertion) and outcome assessors in the post-anaesthesia care unit and at the 24-hour follow-up are blinded to group allocation. The anaesthesiologist inserting the device cannot be blinded because the devices are visibly different.
Investigators: all devices are inserted by board-certified anaesthesiologists with at least 5 years of practice and more than 4,000 documented general anaesthetics.
Anaesthesia protocol: standardized induction with sufentanil 0.3 ug/kg ideal body weight and propofol up to 3 mg/kg titrated to a State Entropy of 40-60. Depth of anaesthesia is maintained at a State Entropy of 40-60. No neuromuscular blocking agents are administered before or during the haemodynamic measurement period; they may be used later during surgery if required. Device size is selected according to the manufacturer's recommendations. After insertion, cuff pressure is measured with a manometer and adjusted to 40-50 cmH2O, below the manufacturers' maximum recommended pressure of 60 cmH2O.
Measurements: mean arterial pressure, heart rate, Surgical Pleth Index (SPI), State Entropy (SE) and Response Entropy (RE) are recorded before laryngeal mask insertion (baseline, at SE 40-60), immediately after insertion, and 5 and 10 minutes after insertion. The number of insertion attempts, need for airway manipulation and oropharyngeal leak pressure are recorded. After device removal, sore throat (VAS), hoarseness, blood staining of the device, coughing and postoperative nausea and vomiting are assessed until discharge from the post-anaesthesia care unit and at 24 hours.
Sample size: a between-group difference of 10% of baseline mean arterial pressure (MAP; approximately 8.2 mmHg at a baseline of 82 mmHg) was considered clinically relevant. The standard deviation of MAP after laryngeal mask insertion was estimated at 12 mmHg, derived from the systolic and diastolic blood pressures reported 5 minutes after LMA Supreme insertion (Iran Red Crescent Med J, doi:10.5812/ircmj.28615) and consistent with the MAP variability reported by Montazari et al. (Acta Med Iran 2004;42:437-440). With a two-sided alpha of 0.0167 (Bonferroni correction for three pairwise comparisons) and 80% power, 47 patients per group are required; allowing for a 10% drop-out rate, 54 patients per group (162 in total) will be enrolled.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Two-centre, three parallel groups with 1:1:1 computer-generated random allocation to one of three laryngeal masks (SaCoVLM, LMA Supreme, Ambu AuraGain).
| Arm | Type | Receives |
|---|---|---|
| SaCoVLM | Active comparator | Device: SaCoVLM video laryngeal maskPatients in whom the airway is secured with the SaCoVLM video laryngeal mask; cuff pressure adjusted to 40-50 cmH2O (n = 54). |
| LMA Supreme | Active comparator | Device: LMA SupremePatients in whom the airway is secured with the LMA Supreme; cuff pressure adjusted to 40-50 cmH2O (n = 54). |
| Ambu AuraGain | Active comparator | Device: Ambu AuraGainPatients in whom the airway is secured with the Ambu AuraGain; cuff pressure adjusted to 40-50 cmH2O (n = 54). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-80 years
- ASA physical status I-II
- Scheduled for elective surgery under general anaesthesia with a laryngeal mask airway indicated
- No history or predictors of difficult airway
- Signed informed consent
Key exclusion criteria (8 listed)
- Refusal to sign informed consent
- ASA physical status III or higher
- Emergency surgery
- Laparoscopic surgery
- Surgery in the prone position
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 secured with the SaCoVLM video laryngeal mask (second-generation supraglottic airway device with integrated video channel), inserted after induction of general anaesthesia according to the manufacturer's instructions. | Device | SaCoVLM |
| LMA SupremeAirway secured with the LMA Supreme (second-generation supraglottic airway device), inserted after induction of general anaesthesia according to the manufacturer's instructions. | Device | LMA Supreme |
| Ambu AuraGainAirway secured with the Ambu AuraGain (second-generation supraglottic airway device), inserted after induction of general anaesthesia according to the manufacturer's instructions. | Device | Ambu AuraGain |
Primary outcome
Maximum Percentage Change in Mean Arterial Pressure From Baseline
Time frame: Baseline (before laryngeal mask insertion), immediately after insertion, and 5 and 10 minutes after insertion
Haemodynamic stress response to laryngeal mask insertion: maximum percentage change in mean arterial pressure (MAP) from the pre-insertion baseline value (measured under standardized anaesthesia at State Entropy 40-60) across the post-insertion measurement points. A between-group difference of 10% of baseline MAP is considered clinically relevant.
12 secondary outcomes
Postoperative Sore Throat Intensity
Time frame: At discharge from the post-anaesthesia care unit (PACU) and 24 hours after laryngeal mask removal
Incidence of Postoperative Sore Throat
Time frame: At discharge from the post-anaesthesia care unit (PACU) and 24 hours after laryngeal mask removal
Change in Heart Rate From Baseline
Time frame: Baseline (before laryngeal mask insertion), immediately after insertion, and 5 and 10 minutes after insertion
Incidence of Hoarseness
Time frame: At discharge from the post-anaesthesia care unit (PACU) and 24 hours after laryngeal mask removal
Blood Staining on the Laryngeal Mask
Time frame: At laryngeal mask removal up to 10 minutes from the removal
Coughing at Laryngeal Mask Removal
Time frame: At laryngeal mask removal up to 10 minutes from the removal
Incidence of Postoperative Nausea and Vomiting (PONV)
Time frame: At discharge from the post-anaesthesia care unit (PACU) and 24 hours after laryngeal mask removal
Change in Surgical Pleth Index (SPI) From Baseline
Time frame: Baseline (before laryngeal mask insertion), immediately after insertion, and 5 and 10 minutes after insertion
Change in the Response Entropy - State Entropy Difference From Baseline
Time frame: Baseline (before laryngeal mask insertion), immediately after insertion, and 5 and 10 minutes after insertion
Number of Insertion Attempts
Time frame: During laryngeal mask insertion
Need for Airway Manipulation
Time frame: From laryngeal mask insertion until 10 minutes after insertion
Oropharyngeal Leak Pressure
Time frame: After laryngeal mask insertion and cuff pressure adjustment
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 9 Oct 2026.
- Background: PubMed 26430529Jarineshin H, Kashani S, Vatankhah M, Abdulahzade Baghaee A, Sattari S, Fekrat F. Better Hemodynamic Profile of Laryngeal Mask Airway Insertion Compared to Laryngoscopy and Tracheal Intubation. Iran Red Crescent Med J. 2015 Aug 12;17(8):e28615. doi: 10.5812/ircmj.28615. eCollection 2015 Aug.
- BackgroundMontazari K, Naghibi Kh, Hashemi SJ. Comparison of hemodynamic changes after insertion of laryngeal mask airway, facemask and endotracheal intubation. Acta Med Iran. 2004;42(6):437-440.
- 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, Ph.D., MBA principal investigator
Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
2 sites 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 Anesthesia, General and Airway Management, run by Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s. at 2 sites 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 5 inclusion and 8 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 9 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 2 sites 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, Ph.D., MBA (+420773628756, michal.kalina@kzcr.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Percentage Change in Mean Arterial Pressure From Baseline (time frame: Baseline (before laryngeal mask insertion), immediately after insertion, and 5 and 10 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 NCT07868848, which also lists 2 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 Oct 2026.