Continuous monitoring and stepwise control of laryngeal mask airway cuff pressure to reduce throat problems after surgery in older adults

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

This trial will test whether continuously monitoring and progressively adjusting the inflatable laryngeal mask airway (LMA) cuff pressure reduces postoperative sore throat and swallowing problems in people aged 60 or older having elective non-thoracic, non-head-and-neck surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 146 (estimated)
• Ages: 60 Years and up
• Sex: All
• Sponsor: First Affiliated Hospital of Chongqing Medical University (Academic / other)
• Locations: 1 site (Chongqing, Chongqing Municipality)
• Trial ID: NCT07461467 on ClinicalTrials.gov

What this trial studies

This is a randomized interventional trial comparing two LMA cuff management approaches in older adults undergoing elective surgery in the supine position. One group receives continuous monitoring with progressive regulation of the inflatable LMA cuff pressure, while the comparator group receives empiric inflation without continuous regulation. Outcomes focus on postoperative pharyngolaryngeal complications such as sore throat and dysphagia measured after surgery. The trial is conducted at a single center (First Affiliated Hospital of Chongqing Medical University) in eligible patients aged 60 and above with ASA I–III and expected surgery duration of 30–120 minutes.

Who should consider this trial

Good fit: Ideal candidates are people aged 60 or older having elective, non-cardiac, non-thoracic, non-head-and-neck, non-laparoscopic surgery in the supine position lasting 30–120 minutes with BMI 18.5–30 kg/m2 and ASA physical status I–III.

Not a fit: Patients with predictable difficult airways, preexisting pharyngeal or laryngeal problems, significant respiratory disease (e.g., COPD or asthma), allergies to LMA materials, or those having thoracic, head-and-neck, laparoscopic surgery, or non-supine positions are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could lower rates of postoperative sore throat and swallowing difficulty and improve comfort and airway safety for older surgical patients.

How similar studies have performed: Prior studies of LMA cuff pressure monitoring have shown reductions in postoperative sore throat and related complications, though continuous progressive regulation targeted specifically at older adults is less extensively tested.

Eligibility criteria

Inclusion Criteria:

* Aged ≥ 60years;
* Non-cardiac, non-thoracic, and non-head and neck surgery;
* Non-laparoscopic surgery;
* Elective surgery;
* Surgical position: supine position ;
* American Society of Anesthesiologists (ASA) physical status classification Ⅰ-Ⅲ;
* New York Heart Association (NYHA) cardiac function classification Ⅰ-Ⅱ;
* Expected surgical duration ≥30 minutes and ≤ 2 hours;
* Body mass index (BMI) 18.5-30.0 kg/m2.

Exclusion Criteria:

* Preoperative predictable difficult airways, such as trismus, limited neck mobility, and other related conditions;
* Preoperative pharyngeal and laryngeal complications including sore throat, hoarseness, blood-tinged sputum, and dysphagia;
* Preexisting conditions such as loose teeth, laryngeal obstruction, laryngeal edema, acute airway inflammation, and gastrointestinal bleeding;
* Comorbidities of respiratory diseases like chronic obstructive pulmonary disease (COPD) and asthma;
* Allergies to ILMA materials (e.g., silicone, polyvinylchloride \[PVC\]);
* Inability to cooperate with the study for any reason;
* Participation in other clinical trials within 3 months prior to enrollment in this study;
* Any other circumstances deemed inappropriate for inclusion by the investigators.

Where this trial is running

Chongqing, Chongqing Municipality

• The First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Su Min

Conditions Elderly; LMA; Randomized Controlled Trial; Laryngeal Mask Airways; Pharyngolaryngeal Postoperative Pain; Cuff Pressure; Oropharyngeal Leak Pressure; Elderly people