Standardized laryngeal mask airway placement with cuff pressure monitoring for 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

The trial enrolls patients aged 60 and older undergoing elective, non-cardiothoracic and non-head/neck surgery with expected duration of 30–120 minutes and BMI 18.5–24.9. Participants receive LMA placement managed through a standardized process that includes cuff pressure monitoring, compared with routine placement practices. The primary outcome is the incidence of perioperative adverse airway reactions and pressure-related injuries. Key exclusions include predicted difficult airway, significant respiratory disease, emergency or non-supine procedures, and allergy to LMA materials.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥60 years old
* Non-cardiothoracic surgery and head and neck surgery
* Elective surgery
* ASA I-III grade
* NYHA cardiac function class I-II
* The operation time is expected to be ≥30 minutes and ≤2 hours
* 18.5≤BMI (kg/m2) ≤24.9

Exclusion Criteria:

* Change to emergency surgery
* Difficult airway that can be predicted before operation, such as difficulty in opening mouth and limited neck movement
* Loose teeth
* Laryngeal obstruction, laryngeal edema, laryngeal abscess, acute airway inflammation, full stomach, acute abdomen, abdominal trauma, drug poisoning, gastrointestinal bleeding
* Complicated with chronic obstructive pulmonary disease, asthma and other respiratory diseases
* Allergic to laryngeal mask materials
* Non-supine position
* Inability to cooperate with the investigator for any reason
* Taking other investigational drugs or participating in other clinical trials within 3 months before study entry
* The investigators considered it inappropriate to be included in the study

Where it's running

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

Study contacts

• Study coordinator: Xuanqi Yang
• Email: 734357421@qq.com
• Phone: +8613408631952

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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

  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.

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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.