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Effect of Laryngeal Mask Cuff Shape on Pharyngeal Stress

ConditionsAnesthesia, GeneralAirway ManagementPostoperative Sore Throat
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMasarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Refusal to sign informed consent

ASA physical status III or higher

Emergency surgery

Laparoscopic surgery

Trial design

Design model

Parallel

Treatments tested in this trial

  • SaCoVLM video laryngeal mask

    Device

    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 Supreme

    Device

    Airway secured with the LMA Supreme (second-generation supraglottic airway device), inserted after induction of general anaesthesia according to the manufacturer's instructions.

  • Ambu AuraGain

    Device

    Airway secured with the Ambu AuraGain (second-generation supraglottic airway device), inserted after induction of general anaesthesia according to the manufacturer's instructions.

Treatment groups

162 Participants
are divided into 3 treatment groups
Group A: SaCoVLMActive comparator 1 intervention
Group B: LMA SupremeActive comparator 1 intervention
Group C: Ambu AuraGainActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.

Lead sponsor

Jan Evangelista Purkyne University in Usti nad Labem, Faculty of Health Studies

Collaborator

Source ClinicalTrials.gov

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