Actively Recruiting

Phase Not Applicable
Age: 60Years +
All Genders
NCT07461467

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

Led by First Affiliated Hospital of Chongqing Medical University · Updated on 2026-03-10

146

Participants Needed

1

Research Sites

69 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 60Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 60 years or older
  • Undergoing elective non-cardiac, non-thoracic, non-head and neck surgery
  • Surgery performed in supine position
  • Surgical duration between 30 minutes and 2 hours
  • American Society of Anesthesiologists (ASA) physical status I to III
  • New York Heart Association (NYHA) cardiac function class I to II
  • Body mass index (BMI) between 18.5 and 30.0 kg/m2
  • Non-laparoscopic surgery
Not Eligible

You will not qualify if you...

  • Predicted difficult airway such as trismus or limited neck mobility
  • Preexisting pharyngeal or laryngeal issues including sore throat, hoarseness, blood-tinged sputum, or dysphagia
  • Loose teeth, laryngeal obstruction, laryngeal edema, acute airway inflammation, or gastrointestinal bleeding
  • Chronic respiratory diseases like COPD or asthma
  • Allergies to materials in the inflatable LMA (e.g., silicone, PVC)
  • Inability to cooperate with the study
  • Participation in other clinical trials within 3 months before enrollment
  • Any other conditions judged inappropriate by investigators

AI-Screening

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Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China, 400016

Actively Recruiting

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Research Team

S

Su Min

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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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 | DecenTrialz