An interventional study of SaCoVLM video laryngeal mask and LMA Supreme in Anesthesia, General, Airway Management and Postoperative Sore Throat, sponsored by Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.. Not yet recruiting at 2 sites in Czechia. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s. · Not applicable, Interventional, and Supportive care
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.
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.
Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s. is the lead sponsor of 21 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients in whom the airway is secured with the SaCoVLM video laryngeal mask; cuff pressure adjusted to 40-50 cmH2O (n = 54).
Device: SaCoVLM video laryngeal mask
Patients in whom the airway is secured with the LMA Supreme; cuff pressure adjusted to 40-50 cmH2O (n = 54).
Device: LMA Supreme
Patients in whom the airway is secured with the Ambu AuraGain; cuff pressure adjusted to 40-50 cmH2O (n = 54).
Device: Ambu AuraGain
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.
Airway secured with the LMA Supreme (second-generation supraglottic airway device), inserted after induction of general anaesthesia according to the manufacturer's instructions.
Airway secured with the Ambu AuraGain (second-generation supraglottic airway device), inserted after induction of general anaesthesia according to the manufacturer's instructions.
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.
Time frame: Baseline (before laryngeal mask insertion), immediately after insertion, and 5 and 10 minutes after insertion
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).
Time frame: 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).
Time frame: 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.
Time frame: Baseline (before laryngeal mask insertion), immediately after insertion, and 5 and 10 minutes after insertion
Incidence of Hoarseness
Presence of hoarseness (yes/no).
Time frame: 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).
Time frame: 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).
Time frame: 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).
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
Surgical Pleth Index (0-100) as an index of the nociceptive response to laryngeal mask insertion; change from the pre-insertion baseline value.
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
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: After laryngeal mask insertion and cuff pressure adjustment
Plan to share: Undecided
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.