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

NCT06954857 | Recruiting DMC

• 1 other identifier: 2025-218-01
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

The laryngeal mask airway (LMA) is a supraglottic ventilation device designed according to human anatomy. It was developed in 1981 by Dr. Archie Boubrain in the United Kingdom to compensate for the deficiencies of tracheal intubation and mask ventilation. It has been widely used in clinical practice because of its simple operation, small airway stimulation, and hemodynamic stability. In 1990, LMA entered the Chinese market. In 1993, LMA was included in the American Society of Anesthesiologists guidelines for the emergency management of the difficult airway. In the past, tracheal intubation was the standard method of airway control during general anesthesia. In the past decade, the proportion of LMA ventilated general anesthesia has increased significantly in China and European and American countries. By 2022, the utilization rate of LMA in China climbed to 95.96%. With the continuous improvement and development of LMA, it can be used to establish safe airway management in special positions such as lateral position and prone position, long-term surgery and special site surgery. However, the wide application has also exposed some key problems. The lack of standardized process management of LMA placement may lead to improper placement, airway obstruction, laryngspasm, reflux, and aspiration during the application of LMA, which may cause a series of pulmonary and extrapulmonary complications. Studies have shown that many adverse events during LMA implantation may be related to LMA pressure monitoring. Inadequate pressure monitoring may lead to pressure imbalance, and improper pressure management may lead to poor coordination between LMA and pharynx. Coupled with the change in intraoperative position and postoperative transfer, the risk of postoperative sore throat and LMA displacement increases. Therefore, there is an urgent need for standardized process management, dynamic pressure monitoring and position adjustment during the use of LMA. The standardized management of LMA insertion involves the standardized selection, placement, maintenance management and transportation of LMA. Especially for the elderly population, LMA displacement is more likely to occur due to the atrophy of pharyngeal mucosa and muscle, weakened cough reflex, and decreased chest wall compliance, which increases the incidence of pulmonary and extrapulmonary complications. For elderly patients with atherosclerosis, LMA displacement and relatively high cuff pressure may compress the jugular and jugular veins in the neck and surrounding tissues, increasing the risk of stroke in elderly patients. Effective and safe anesthesia airway and respiratory management strategies during general anesthesia will directly affect the occurrence of postoperative pulmonary complications (PPCs) and the incidence of sore throat in elderly patients. Standardized management of LMA and continuous pressure monitoring and adjustment can improve the above adverse reactions. At present, there is a lack of large-scale and reliable evidence-based medical evidence to evaluate the effect of standardized process management of laryngeal mask insertion based on pressure monitoring on perioperative adverse reactions in elderly patients with high risk of pulmonary complications. Especially in the elderly population with a high incidence of PPCs, the safety, short - and long-term advantages and disadvantages of widespread use of LMA ventilation are still unclear. Therefore, it is particularly urgent to carry out the effect of standardized process management of laryngeal mask insertion based on pressure monitoring on perioperative adverse reactions in elderly patients, and to further explore the appropriate range of laryngeal mask related pressure indicators. This study based on the concept of enhanced recovery after surgery (ERAS) can not only fill the current research gap, but also provide strong support for safe and efficient airway management in elderly patients during the perioperative period, and effectively promote the further optimization of clinical practice, which has extremely important clinical significance and practical value.

Conditions

LMA; Pressure Injury; Elderly; Airway Management

Keywords

Laryngeal Mask Airway (LMA); Pressure Monitoring; Elderly Patients; Complications; ERAS

Outcome Measures

Primary Outcomes (1)

• The incidence of sore throat

  VAS scale was used to evaluate the scores. The scale consisted of a 10-cm straight line, with the left end of the line indicating "no pain" and the right end indicating "severe pain". A total of 6 different degrees of facial expressions were used to express the degree of pain, including no pain, slight pain, mild pain, moderate pain, severe pain and severe pain. In this study, sore throat was considered to occur as long as VAS≥3 points at any evaluation time point after LMA removal.

  10 minutes, 1 hour, 2 hours, 24 hours, and 48 hours after LMA removal

Secondary Outcomes (8)

• The incidence of intraoperative laryngeal mask displacement

  intraoperatively

• The incidence of pulmonary complications within 7 days after surgery

  within 7 days after surgery

• The length of hospital stay

  within 7 days after surgery

• The score of Laryngeal mask alignment

  Within 5 minutes after laryngeal mask placement

• Arterial partial pressure of oxygen

  perioperative period

Study Arms (2)

Experimental group: the pressure was monitored and adjusted in real time

EXPERIMENTAL

The measured and adjusted airway pressure, cuff pressure and leak pressure were recorded

Device: Cuff pressure monitor

Control group：the pressure was measured once after empirical inflation of the laryngeal mask

NO INTERVENTION

The cuff pressure, airway pressure, and leak pressure were measured only once after empirical inflation under the condition of guaranteed ventilation

Interventions

Cuff pressure monitor DEVICE

Participants were allocated to the experimental group and the control group using block randomization. Experimental group: A pressure monitor was used to continuously monitor and promptly adjust the cuff pressure, seal pressure, and leakage pressure of the laryngeal mask.

Experimental group: the pressure was monitored and adjusted in real time

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• ≤BMI (kg/m2) ≤24.9

You may not qualify if:

• 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

Sponsors & Collaborators

• Xuanqi Yang: lead
• First Affiliated Hospital of Chongqing Medical University: collaborator

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

RECRUITING

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Xuanqi Yang

CONTACT

+8613408631952; 734357421@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident physicians

Study Record Dates

• First Submitted: April 3, 2025
• First Posted: May 2, 2025
• Study Start: May 9, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)