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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Su Min
• Email: yangxuanqi1221@163.com
• Phone: 13408631952

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.