Actively Recruiting
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
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the effects of continuous monitoring and progressive regulation of inflatable laryngeal mask airway (LMA) cuff pressure on postoperative throat-related complications in elderly patients undergoing surgery. This study addresses a critical gap in research focusing on elderly patients, who face higher risks of pulmonary and throat complications during anesthesia due to natural physiological declines. It aims to improve airway management safety and effectiveness during the perioperative period by identifying the optimal cuff pressure range. The study is a prospective, single-center, randomized controlled trial comparing two groups of elderly patients receiving general anesthesia with LMA ventilation. One group receives continuous cuff pressure monitoring with progressive pressure regulation to maintain safe levels, starting at 40 cmH2O and adjusted downward during surgery. The other group receives empirical cuff inflation based on anesthesiologist experience, with pressure monitoring but no adjustments. Both groups undergo standard surgical procedures in the supine position with specific inclusion criteria including non-cardiac and non-thoracic surgeries. Participants will be monitored before, during, and after surgery for pharyngolaryngeal complications such as sore throat, hoarseness, mucosal injury, blood on the LMA, and swallowing difficulties. Additional assessments include difficulty and duration of LMA insertion, airway complications, pulmonary complications within 7 and 30 days post-surgery, hospital stay length, medical costs, and patient satisfaction. The study enrolls participants aged 60 and above, with a planned follow-up until at least 48 hours post-LMA removal, providing thorough evaluation of airway safety and recovery outcomes.
CONDITIONS
Brief 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
Eligibility Criteria
You may qualify if you...
- Aged 60 years or older
- Undergoing elective surgery in the supine position
- Surgery is non-cardiac, non-thoracic, and non-head or neck
- Surgery is non-laparoscopic
- American Society of Anesthesiologists (ASA) physical status I to III
- New York Heart Association (NYHA) cardiac function class I to II
- Expected surgery duration between 30 minutes and 2 hours
- Body mass index (BMI) between 18.5 and 30.0 kg/m2
You will not qualify if you...
- Known difficult airway conditions such as limited mouth opening or neck movement
- Preoperative throat or laryngeal issues like sore throat, hoarseness, blood-tinged sputum, or swallowing difficulties
- Existing conditions including loose teeth, laryngeal obstruction, edema, airway inflammation, or gastrointestinal bleeding
- Respiratory diseases such as chronic obstructive pulmonary disease (COPD) or asthma
- Allergies to laryngeal mask airway materials like silicone or PVC
- Inability to cooperate with the study for any reason
- Participation in other clinical trials within 3 months before enrollment
- Any other conditions deemed unsuitable by the investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery duration between 30 minutes and 2 hours
Participants undergo general anesthesia with an inflatable laryngeal mask airway (LMA). The LMA cuff pressure is either continuously monitored and progressively regulated or empirically inflated and monitored without intervention during the surgical procedure.
1 visit (in-person) during surgery
Duration - Up to 30 days after surgery
Participants are assessed for postoperative pharyngolaryngeal complications such as sore throat, hoarseness, mucosal injury, blood on the LMA or in sputum, and dysphagia at multiple timepoints up to 48 hours after LMA removal. Additional evaluations for airway and pulmonary complications occur within 7 and 30 days postoperatively, along with patient satisfaction assessment on postoperative day 3.
Multiple visits at 10 minutes, 30 minutes, 1 hour, 2 hours, 24 hours, and 48 hours after LMA removal, plus assessments within 7 and 30 days postoperatively
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400016
Actively Recruiting
Research Team
S
Su Min
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here