Effect of Laryngeal Mask Cuff Shape on Pharyngeal Stress

Study acronym: CUFFSTRESS
StatusNot Yet Recruiting
PhaseNot applicable
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT07868848
Lead Sponsor Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
Collaborators: Jan Evangelista Purkyne University in Usti nad Labem, Faculty of Health Studies
Conditions
(from sponsor)
Anesthesia, General, Airway Management, Postoperative Sore Throat
Enrollment 162 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov