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

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.

Conditions

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

Interventions

OTHER

Regulated 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.

OTHER

Empirically 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.

Sponsors & Collaborators

• First Affiliated Hospital of Chongqing Medical University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-11-02

Primary Completion

2027-02-01

Completion

2027-03-01

Countries

• China

Study Locations