RecruitingNot ApplicableNCT07461467

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

Sponsor

First Affiliated Hospital of Chongqing Medical University

Enrollment

146 participants

Start Date

Nov 2, 2025

Study Type

INTERVENTIONAL

Conditions

Randomized Controlled Trial Elderly (People Aged 65 or More)LMA Laryngeal Mask Airways Pharyngolaryngeal Postoperative Pain Cuff Pressure

Summary

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 practice scenarios, and have provided important evidence for the safe and effective use of LMA in specific groups through in-depth research. However, it is undeniable that there are obvious deficiencies in both domestic and foreign research regarding the application of continuous monitoring and progressive regulation of LMA cuff pressure in elderly patients-a crucial field. Due to the natural decline of physiological functions, elderly patients face an increased risk of complications such as pulmonary and extrapulmonary complications, as well as pharyngolaryngeal complications, when using LMA during the perioperative period. Therefore, it is particularly urgent to carry out continuous pressure monitoring and progressive regulation of LMA cuff pressure, and to further explore the optimal range of LMA cuff pressure. This study will not only fill the current research gap but also provide solid support for the safe and efficient airway management of elderly patients during the perioperative period.

Eligibility

Min Age: 60 Years

Inclusion Criteria9

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 Criteria8

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.

Print for Your Doctor

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERRegulated and monitored ILMA

In group RM, the ILMA cuff was first inflated to 40cmH2O using a pressure monitor, followed by continuous monitoring. This initial pressure was chosen based on previous studies, pre-experimental data and clinical observation, which indicated that it was sufficiently high to ensure an OLP ≥ 25 cmH2O in the vast majority of pilot cases, thereby providing a safe and consistent starting point for downward regulation. Then the OLP was measured. OLP measurement method: manual positive-pressure ventilation mode, closed APL valve, 3 L/min oxygen flow, with plateau pressure at audible mouth leakage defined as OLP.

OTHEREmpirically inflated LMA

In group EI, anesthesiologists inflated the ILMA cuff based on their clinical experience using a 20 mL syringe, with the goal of achieving empirical inflation that ensured unobstructed ventilation. Subsequently, the cuff pressure was passively measured and recorded using a cuff pressure monitor, the measured pressure values were blinded to the anesthesiologists and no adjustments were made. This design ensured that group EI represented conventional empirical management with added observation only.