Standardized laryngeal mask airway placement with cuff pressure monitoring for older adults
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
This tests whether using a cuff pressure monitor when placing a laryngeal mask airway reduces airway-related adverse reactions in older adults having elective surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 78 (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 | NCT06954857 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 60 or older scheduled for elective, non-cardiothoracic and non-head/neck surgery under general anesthesia who are ASA I–III, NYHA I–II, with BMI 18.5–24.9 and expected operation time between 30 minutes and 2 hours.
Not a fit: Patients with predicted difficult airways, chronic obstructive respiratory disease or asthma, emergency surgeries, non-supine positions, allergy to LMA materials, or inability to cooperate are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this could reduce airway injury and postoperative throat complications in elderly surgical patients.
How similar studies have performed: Animal experiments and some clinical reports suggest appropriate LMA cuff pressure reduces tissue injury, but standardized pressure-monitoring protocols in elderly perioperative patients are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Chongqing, Chongqing Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.