Effects of Continuous Monitoring and Progressive Regulation of Inflatable Laryngeal Mask Airway Cuff Pressure on Postoperative Pharyngolaryngeal Complications in Elderly Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- The incidence of postoperative pharyngeal pain
研究概览
简要总结
Currently, research on laryngeal mask airway (LMA) has been continuously deepened both domestically and internationally, which has greatly promoted the optimization process of clinical application and related management strategies. Numerous domestic and foreign research findings have consistently emphasized the key role of LMA cuff pressure monitoring in reducing postoperative complications, especially in alleviating sore throat and dysphagia. Foreign studies have extensively covered the research and development innovation of LMA devices, as well as comprehensive comparative analyses with other airway management methods such as endotracheal intubation, providing rich perspectives for expanding the application of LMA and improving its application effects. In contrast, domestic studies have distinct pertinence, focusing on application exploration in specific populations and clinical practice scenarios, and have provided important evidence for the safe and effective use of LMA in specific groups through in-depth research. However, it is undeniable that there are obvious deficiencies in both domestic and foreign research regarding the application of continuous monitoring and progressive regulation of LMA cuff pressure in elderly patients-a crucial field. Due to the natural decline of physiological functions, elderly patients face an increased risk of complications such as pulmonary and extrapulmonary complications, as well as pharyngolaryngeal complications, when using LMA during the perioperative period. Therefore, it is particularly urgent to carry out continuous pressure monitoring and progressive regulation of LMA cuff pressure, and to further explore the optimal range of LMA cuff pressure. This study will not only fill the current research gap but also provide solid support for the safe and efficient airway management of elderly patients during the perioperative period.
详细描述
The laryngeal mask airway (LMA) is a supraglottic ventilation device designed based on human anatomy, developed by Dr. Archie Brain from the United Kingdom in 1981, aiming to overcome the limitations of tracheal intubation and mask ventilation. Due to its advantages of easy operation, minimal airway stimulation, and stable hemodynamics, LMA has been widely used in clinical practice. In the past, tracheal intubation was the standard method for airway control during general anesthesia. Nowadays, in China, Europe, and the United States, the proportion of general anesthesia using LMA for ventilation has increased significantly over the past decade. By 2022, as an emergency airway device, the utilization rate of LMA in China had risen to 95.96% . With continuous improvement and development, LMA can also establish safe airway management in special positions such as lateral and prone positions, as well as in long-duration and special-site surgeries.
However, the widespread application has also exposed critical issues. Malposition, airway obstruction, laryngospasm, regurgitation, and aspiration may occur during LMA use, leading to a series of pulmonary and extrapulmonary complications. Studies have shown that many adverse events during LMA insertion may be related to cuff pressure monitoring. The lack of pressure monitoring results in pressure imbalance; inappropriate pressure management may lead to poor fitting between the LMA and the pharyngeal mucosa. Combined with intraoperative position changes and postoperative transportation, the risks of postoperative sore throat and LMA displacement are increased. Therefore, there is an urgent need for dynamic pressure monitoring during LMA use.
In terms of LMA pressure management, first, precise control of cuff pressure is the core. Cuff pressure refers to the pressure inside the LMA cuff after inflation, which is related to the inflation volume, LMA size, temperature, and other factors. For inflatable LMAs, clinicians usually inflate the pilot balloon and valve via a syringe empirically, judging cuff distension by the appearance of the pilot balloon, with the goal of achieving an airtight seal, adequate tidal volume, and normal peak airway pressure.
Insufficient cuff pressure may lead to inadequate ventilation, while excessive pressure compresses the pharyngeal mucosa and causes postoperative pharyngolaryngeal complications. In addition, nitrous oxide (N₂O) inhalation during clinical anesthesia can increase cuff pressure; thus, regular monitoring of cuff pressure is of great significance. Previous clinical studies used homemade cuff pressure gauges to monitor LMA cuff pressure and set cuff pressure according to peak airway pressure, showing that appropriate inflation volume under cuff pressure monitoring and setting LMA cuff pressure at Ppeak + 0-5 cmH₂O during general anesthesia with LMA ventilation can achieve a satisfactory seal and reduce the incidence of postoperative pharyngolaryngeal complications. Studies exploring appropriate inflation volumes for LMA cuffs have suggested that low cuff pressure is conducive to enhanced postoperative recovery.
Second, the sealing pressure of the LMA refers to the pressure required to form an effective seal between the LMA and the surrounding laryngeal tissues, formed by matching and compression between the cuff and the periglottic structures. It reflects LMA positioning and pharyngeal fitting, and is related to LMA type and patient laryngeal anatomy. Leak pressure is defined as the pressure at which gas escapes from the edge of the LMA as airway pressure gradually increases. Oropharyngeal leak pressure (OPLP) is commonly used clinically to evaluate the reliability of LMA sealing during ventilation. Some studies have suggested that it is the most accurate description of peripharyngeal gas leak pressure, which is affected by upper airway anatomy, anesthetic agents, LMA size, surgical position, and other factors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Empirically inflated LMA
In group EI, anesthesiologists inflated the ILMA cuff based on their clinical experience using a 20 mL syringe, with the goal of achieving empirical inflation that ensured unobstructed ventilation. Subsequently, the cuff pressure was passively measured and recorded using a cuff pressure monitor, the measured pressure values were blinded to the anesthesiologists and no adjustments were made. This design ensured that group EI represented conventional empirical management with added observation only.
干预措施: Empirically inflated LMA (Other)
Regulated and monitored ILMA
In group RM, the ILMA cuff was first inflated to 40cmH2O using a pressure monitor, followed by continuous monitoring. This initial pressure was chosen based on previous studies, pre-experimental data and clinical observation, which indicated that it was sufficiently high to ensure an OLP ≥ 25 cmH2O in the vast majority of pilot cases, thereby providing a safe and consistent starting point for downward regulation. Then the OLP was measured. OLP measurement method[: manual positive-pressure ventilation mode, closed APL valve, 3 L/min oxygen flow, with plateau pressure at audible mouth leakage defined as OLP.
干预措施: Regulated and monitored ILMA (Other)
结局指标
主要结局
The incidence of postoperative pharyngeal pain
时间窗: Before LMA insertion (Time 0), at LMA removal (Time 1), and 10 minutes (Time 2), 30 minutes (Time 3), 1 hour (Time 4), 2 hours (Time 5), 24 hours (Time 6), and 48 hours (Time 7) after LMA removal.
Pharyngeal pain was evaluated using the Visual Analogue Scale (VAS), with a score ≥ 3 defined as the occurrence of pharyngeal pain.
The incidence of postoperative supraglottic pharyngeal mucosal injury
时间窗: Baseline (before LMA insertion);Intraoperative (at LMA insertion);Intraoperative (at LMA removal)
Supraglottic pharyngeal mucosal injury was assessed using a fiberoptic bronchoscopy-based mucosal lesion grading system. An increase in the grade compared to that at LMA insertion was defined as the occurrence of mucosal injury.
The incidence of postoperative hoarseness
时间窗: Before LMA insertion (Time 0), at LMA removal (Time 1), and 10 minutes (Time 2), 30 minutes (Time 3), 1 hour (Time 4), 2 hours (Time 5), 24 hours (Time 6), and 48 hours (Time 7) after LMA removal.
Hoarseness was graded according to a hoarseness severity scale, with a grade ≥ 1 defined as the occurrence of hoarseness.
The incidence of postoperative blood on the laryngeal mask airway (LMA) surface or in sputum
时间窗: Before LMA insertion (Time 0), at LMA removal (Time 1), and 10 minutes (Time 2), 30 minutes (Time 3), 1 hour (Time 4), 2 hours (Time 5), 24 hours (Time 6), and 48 hours (Time 7) after LMA removal.
Blood on the LMA surface was observed by the clinician removing the LMA, while blood in sputum was either observed by the clinician or self-reported by the patient/family.
The incidence of postoperative dysphagia
时间窗: Before LMA insertion (Time 0), at LMA removal (Time 1), and 10 minutes (Time 2), 30 minutes (Time 3), 1 hour (Time 4), 2 hours (Time 5), 24 hours (Time 6), and 48 hours (Time 7) after LMA removal.
Dysphagia/discomfort on swallowing was self-reported by the patient.
次要结局
- The incidence of other perioperative airway complications(Within 7 days postoperatively)
- Incidence of pulmonary complications(within 7 days and 30 days postoperatively)
- Patient satisfaction(On postoperative day 3)
研究者
Min Su
professor
First Affiliated Hospital of Chongqing Medical University
