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Effects of Continuous Monitoring and Progressive Regulation of Inflatable Laryngeal Mask Airway Cuff Pressure on Postoperative Pharyngolaryngeal Complications in Elderly Patients

RecruitingNAAges 60 Years - anyAllFirst Affiliated Hospital of Chongqing Medical Un…
NCT07461467 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Currently, research on laryngeal mask airway (LMA) has been continuously deepened both domestically and internationally, which has greatly promoted the optimization process of clinical application and related management strategies. Numerous domestic and foreign research findings have consistently emphasized the key role of LMA cuff pressure monitoring in reducing postoperative complications, especially in alleviating sore throat and dysphagia. Foreign studies have extensively covered the research and development innovation of LMA devices, as well as comprehensive comparative analyses with other airway management methods such as endotracheal intubation, providing rich perspectives for expanding the application of LMA and improving its application effects. In contrast, domestic studies have distinct pertinence, focusing on application exploration in specific populations and clinical practi

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📋 Eligibility rules (as published)
Inclusion Criteria: * Aged ≥ 60years; * Non-cardiac, non-thoracic, and non-head and neck surgery; * Non-laparoscopic surgery; * Elective surgery; * Surgical position: supine position ; * American Society of Anesthesiologists (ASA) physical status classification Ⅰ-Ⅲ; * New York Heart Association (NYHA) cardiac function classification Ⅰ-Ⅱ; * Expected surgical duration ≥30 minutes and ≤ 2 hours; * Body mass index (BMI) 18.5-30.0 kg/m2. Exclusion Criteria: * Preoperative predictable difficult airways, such as trismus, limited neck mobility, and other related conditions; * Preoperative pharyngeal and laryngeal complications including sore throat, hoarseness, blood-tinged sputum, and dysphagia; * Preexisting conditions such as loose teeth, laryngeal obstruction, laryngeal edema, acute airway inflammation, and gastrointestinal bleeding; * Comorbidities of respiratory diseases like chronic obstructive pulmonary disease (COPD) and asthma; * Allergies to ILMA materials (e.g., silicone, polyvinylchloride \[PVC\]); * Inability to cooperate with the study for any reason; * Participation in other clinical trials within 3 months prior to enrollment in this study; * Any other circumstances deemed inappropriate for inclusion by the investigators.
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What it tests

  • Regulated and monitored ILMA
  • Empirically inflated LMA
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Where

1 site
The First Affiliated Hospital of Chongqing Medical University
Chongqing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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