Effect of Laryngeal Mask Cuff Shape on Pharyngeal Stress

NCT07868848 | Not Yet Recruiting

• 1 other identifier: CUFFSTRESS
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Anesthesia, General; Airway Management; Postoperative Sore Throat

Keywords

laryngeal mask airway; supraglottic airway device; cuff design; haemodynamic response; pharyngeal morbidity; SaCoVLM; LMA Supreme; Ambu AuraGain

Outcome Measures

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.

  Baseline (before laryngeal mask insertion), immediately after insertion, and 5 and 10 minutes after insertion

Secondary Outcomes (12)

• Postoperative Sore Throat Intensity

  At discharge from the post-anaesthesia care unit (PACU) and 24 hours after laryngeal mask removal

• Incidence of Postoperative Sore Throat

  At discharge from the post-anaesthesia care unit (PACU) and 24 hours after laryngeal mask removal

• Change in Heart Rate From Baseline

  Baseline (before laryngeal mask insertion), immediately after insertion, and 5 and 10 minutes after insertion

• Incidence of Hoarseness

  At discharge from the post-anaesthesia care unit (PACU) and 24 hours after laryngeal mask removal

• Blood Staining on the Laryngeal Mask

  At laryngeal mask removal up to 10 minutes from the removal

Study Arms (3)

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).

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).

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).

Device: Ambu AuraGain

Interventions

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.

SaCoVLM

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.

LMA Supreme

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.

Ambu AuraGain

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.: lead
• Jan Evangelista Purkyne University in Usti nad Labem, Faculty of Health Studies: collaborator

Study Sites (2)

Nemocnice Decin, Krajska Zdravotni a.s.

Děčín, Ústí nad Labem Region, 405 99, Czechia

Location

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

Ústí nad Labem, Ústí nad Labem Region, 401 13, Czechia

Location

Related Publications (2)

• 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.

  PMID: 26430529 BACKGROUND

• Montazari 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.

  BACKGROUND

Study Officials

• Michal Kalina, MD, Ph.D., MBA

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michal Kalina, MD, Ph.D., MBA

CONTACT

+420773628756; michal.kalina@kzcr.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients are anaesthetized during device insertion and are not informed of the allocated device. Outcome assessors in the post-anaesthesia care unit and at the 24-hour follow-up are unaware of group allocation. The anaesthesiologist inserting the device cannot be blinded because the devices are visibly different.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two-centre, three parallel groups with 1:1:1 computer-generated random allocation to one of three laryngeal masks (SaCoVLM, LMA Supreme, Ambu AuraGain).

Study Record Dates

• First Submitted: September 28, 2026
• First Posted: October 9, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2028
• Last Updated: October 9, 2026

Record last verified: 2026-10

Locations

CZ (2)