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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Study 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

Primary outcome measure(s)

• The incidence of postoperative pharyngeal pain — Before LMA insertion (Time 0), at LMA removal (Time 1), and 10 minutes (Time 2), 30 minutes (Time 3), 1 hour (Time 4), 2 hours (Time 5), 24 hours (Time 6), and 48 hours (Time 7) after LMA removal.
  Pharyngeal pain was evaluated using the Visual Analogue Scale (VAS), with a score ≥ 3 defined as the occurrence of pharyngeal pain.
• The incidence of postoperative supraglottic pharyngeal mucosal injury — Baseline (before LMA insertion)；Intraoperative (at LMA insertion)；Intraoperative (at LMA removal)
  Supraglottic pharyngeal mucosal injury was assessed using a fiberoptic bronchoscopy-based mucosal lesion grading system. An increase in the grade compared to that at LMA insertion was defined as the occurrence of mucosal injury.
• The incidence of postoperative hoarseness — Before LMA insertion (Time 0), at LMA removal (Time 1), and 10 minutes (Time 2), 30 minutes (Time 3), 1 hour (Time 4), 2 hours (Time 5), 24 hours (Time 6), and 48 hours (Time 7) after LMA removal.
  Hoarseness was graded according to a hoarseness severity scale, with a grade ≥ 1 defined as the occurrence of hoarseness.
• The incidence of postoperative blood on the laryngeal mask airway (LMA) surface or in sputum — Before LMA insertion (Time 0), at LMA removal (Time 1), and 10 minutes (Time 2), 30 minutes (Time 3), 1 hour (Time 4), 2 hours (Time 5), 24 hours (Time 6), and 48 hours (Time 7) after LMA removal.
  Blood on the LMA surface was observed by the clinician removing the LMA, while blood in sputum was either observed by the clinician or self-reported by the patient/family.
• The incidence of postoperative dysphagia — Before LMA insertion (Time 0), at LMA removal (Time 1), and 10 minutes (Time 2), 30 minutes (Time 3), 1 hour (Time 4), 2 hours (Time 5), 24 hours (Time 6), and 48 hours (Time 7) after LMA removal.
  Dysphagia/discomfort on swallowing was self-reported by the patient.

Trial sites (1)

More First Affiliated Hospital of Chongqing Medical University trials in China

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