Individualized regulation of inflatable laryngeal mask airway cuff pressure reduces postoperative pharyngolaryngeal pain in elderly patients: a randomized controlled trial.
Xuanqi Yang, Sixu Lai, Su Min...
https://pubmed.ncbi.nlm.nih.gov/42221130/Actively Recruiting
Led by Xuanqi Yang · Updated on 2025-07-10
78
Participants Needed
1
Research Sites
4 weeks
Total Duration
Researchers are studying elderly patients aged 60 and older undergoing elective non-cardiothoracic and head and neck surgeries to evaluate how standardized process management of laryngeal mask airway LMA placement based on pressure monitoring affects the occurrence of adverse reactions during the perioperative period. The study aims to address problems related to improper LMA placement, airway obstruction, and complications like postoperative sore throat and pulmonary issues, which are especially concerning in elderly patients with weakened airway tissues and reduced chest compliance. This research is important because current clinical practice lacks standardized pressure monitoring during LMA use, and improving this could enhance patient safety and recovery. The trial compares two approaches an experimental group where LMA cuff pressure, sealing pressure, and leakage pressure are continuously monitored and adjusted in real time using a pressure monitor device and a control group where these pressures are measured only once after empirical inflation to ensure ventilation. This randomized, single-blind study involves standardized management of LMA insertion, including selection, placement, maintenance, and patient positioning to maintain proper LMA alignment and effective ventilation. The study explores dynamic pressure monitoring and adaptive adjustments during surgery, particularly in different body positions. Participants will be assessed for the incidence of sore throat at multiple timepoints after LMA removal, as well as occurrences of LMA displacement during surgery and pulmonary complications within seven days after surgery. Other evaluations include hospital stay length, arterial oxygen and carbon dioxide levels, inflammatory factor changes, alignment scoring of the LMA shortly after placement, and hospitalization costs. The study emphasizes careful monitoring of adverse events and aims to generate reliable evidence to improve airway management and patient outcomes in elderly surgical patients over a total participation period covering surgery and follow-up assessments.
CONDITIONS
The Influence of Standardized Process Management of Laryngeal Mask Airway Placement Based on Pressure Monitoring on the Incidence of Adverse Reactions in Elderly Patients During the Perioperative Period
X
Xuanqi Yang
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Xuanqi Yang
Lead Sponsor
First Affiliated Hospital of Chongqing Medical University
Collaborating Sponsor
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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 laryngeal mask airway placement during surgery with either continuous pressure monitoring and adjustment or a single pressure measurement after empirical inflation.
1 surgical procedure visit (in-person)
Duration - Up to 7 days after surgery
Participants are monitored for postoperative adverse reactions including sore throat and pulmonary complications, with assessments up to 7 days after surgery.
Multiple visits for assessments at 10 minutes, 1 hour, 2 hours, 24 hours, and 48 hours after LMA removal, plus follow-up within 7 days
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Xuanqi Yang, Sixu Lai, Su Min...
https://pubmed.ncbi.nlm.nih.gov/42221130/Xuanqi Yang
Lead Sponsor
First Affiliated Hospital of Chongqing Medical University
Collaborating Sponsor