Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-04-05 @ 6:20 AM
Study NCT ID:
NCT07461467
Status:
RECRUITING
Last Update Posted:
2026-03-10
First Post:
2026-02-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Continuous Monitoring and Progressive Regulation of Inflatable Laryngeal Mask Airway Cuff Pressure on Postoperative Pharyngolaryngeal Complications in Elderly Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012926', 'term': 'Social Control, Formal'}], 'ancestors': [{'id': 'D004472', 'term': 'Health Care Economics and Organizations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Individualized regulation proceeded as follows: (1) If OLP was ≥ 25 cmH2O: pressure was reduced in 2 cmH2O increments to the minimum value maintaining unobstructed ventilation, OLP ≥ 25 cmH2O, and cuff pressure ≥ peak airway pressure. If the OLP \\< 25 cmH₂O: ILMA position was rechecked; with correct placement, pressure was increased in 5 cmH₂O increments until OLP ≥ 25 cmH₂O or 60 cmH₂O (safety limit). If OLP met the target after upward adjustment, downward regulation was performed as above. For regulation failure (OLP \\< 25 cmH₂O at 60 cmH₂O) or persistent ILMA malposition, ILMA size was changed, or alternative supraglottic airway device/endotracheal intubation was used to ensure patient safety.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 146}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-06', 'studyFirstSubmitDate': '2026-02-12', 'studyFirstSubmitQcDate': '2026-03-06', 'lastUpdatePostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of postoperative pharyngeal pain', 'timeFrame': '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.', 'description': 'Pharyngeal pain was evaluated using the Visual Analogue Scale (VAS), with a score ≥ 3 defined as the occurrence of pharyngeal pain.'}, {'measure': 'The incidence of postoperative supraglottic pharyngeal mucosal injury', 'timeFrame': 'Baseline (before LMA insertion)；Intraoperative (at LMA insertion)；Intraoperative (at LMA removal)', 'description': '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.'}, {'measure': 'The incidence of postoperative hoarseness', 'timeFrame': '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.', 'description': 'Hoarseness was graded according to a hoarseness severity scale, with a grade ≥ 1 defined as the occurrence of hoarseness.'}, {'measure': 'The incidence of postoperative blood on the laryngeal mask airway (LMA) surface or in sputum', 'timeFrame': '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.', 'description': '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.'}, {'measure': 'The incidence of postoperative dysphagia', 'timeFrame': '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.', 'description': 'Dysphagia/discomfort on swallowing was self-reported by the patient.'}], 'secondaryOutcomes': [{'measure': 'The incidence of other perioperative airway complications', 'timeFrame': 'Within 7 days postoperatively', 'description': 'such as laryngospasm, LMA displacement, hypoxemia'}, {'measure': 'Incidence of pulmonary complications', 'timeFrame': 'within 7 days and 30 days postoperatively', 'description': 'Mainly including respiratory tract infection, pulmonary infection, respiratory failure, atelectasis, pulmonary embolism, acute lung injury, aspiration pneumonia, acute respiratory distress syndrome (ARDS), and unplanned intubation.\n\nDefinitions:\n\nThe diagnosis of respiratory tract infection, pulmonary infection, atelectasis, pulmonary embolism, acute lung injury, and aspiration pneumonia requires clear clinical history and supporting imaging findings.\n\nThe diagnosis of ARDS is based on the Berlin definition.'}, {'measure': 'Patient satisfaction', 'timeFrame': 'On postoperative day 3', 'description': 'Patient satisfaction was evaluated using a 5-point Likert scale, covering multiple dimensions including perioperative comfort, postoperative recovery, and investigator attitude.\n\nScores ranged from 1 to 5, with responses graded as very satisfied (5), satisfied (4), neutral (3), dissatisfied (2), and very dissatisfied (1).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Elderly people', 'Laryngeal mask airways', 'pharyngolaryngeal complications', 'cuff pressure', 'Randomized Controlled Trial'], 'conditions': ['Elderly (People Aged 65 or More)', 'LMA', 'Randomized Controlled Trial', 'Laryngeal Mask Airways', 'Pharyngolaryngeal Postoperative Pain', 'Cuff Pressure', 'Oropharyngeal Leak Pressure']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nHowever, 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.\n\nIn 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.\n\nInsufficient 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.\n\nSecond, 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.\n\nThus, maintaining appropriate LMA pressure to ensure correct positioning, effective ventilation, and reduced adverse events is extremely important. However, current clinical practice does not mandate monitoring of cuff pressure or other pressure indicators; there is no standardized pressure measurement method, nor are there sufficient studies investigating LMA pressure values in different positions or defining optimal pressure ranges.\n\nA previous study explored appropriate cuff inflation volumes for LMA, defining the optimal inflation volume as that achieving positive pressure ventilation \\> 17 cmH₂O, LMA cuff pressure of 40-80 cmH₂O, and oropharyngeal leak pressure \\> 20 cmH₂O, but this study was limited to size 4 LMA. Regarding cuff pressure monitoring using a manometer, one study compared the accuracy of the digital palpation method, passive deflation method, and minimal occlusive volume method in endotracheal tube cuff pressure monitoring, indicating that the passive deflation method provided the highest accuracy.\n\nIn this field, Wang et al. developed a mobile application for real-time monitoring and adjustment of endotracheal tube cuff pressure, which maintained cuff pressure within a reasonable range and significantly reduced postoperative adverse events. Whether such methods are applicable to LMA pressure monitoring requires further investigation. Expert consensus on the clinical application and management of laryngeal mask airways also emphasizes the importance of measuring LMA-related pressures such as cuff pressure.\n\nEspecially in the elderly population, due to atrophy of pharyngeal mucosa and muscles, weakened cough reflex, and decreased chest wall compliance, adverse pharyngeal reactions tend to occur after mechanical ventilation. Furthermore, elderly patients have lower oropharyngeal leak pressure than ordinary patients, making LMA displacement more likely and increasing the incidence of pulmonary and extrapulmonary complications. In patients with atherosclerosis, LMA displacement and high cuff pressure may compress the cervical arteries, veins, and surrounding tissues, increasing the risk of stroke in the elderly.\n\nEffective and safe anesthetic airway and respiratory management during general anesthesia directly affects the occurrence of postoperative pulmonary complications (PPCs) in elderly patients. Globally, the incidence of PPCs ranges from 11% to 59%. PPCs not only prolong hospital stay and increase medical costs but also impair prognosis, raise perioperative mortality, and impose a heavy socioeconomic and medical resource burden. Continuous monitoring and regulation of LMA cuff pressure may alleviate these problems.\n\nCurrently, there is a lack of large-scale, reliable evidence-based medical data evaluating the effects of continuous monitoring and progressive regulation of LMA cuff pressure on postoperative pharyngolaryngeal complications, especially regarding the safety and short- and long-term outcomes of extensive LMA use in elderly patients, a high-risk population for PPCs. Therefore, it is particularly urgent to conduct research on the effects of LMA cuff pressure monitoring and regulation on postoperative pharyngolaryngeal complications in elderly patients and to further explore the optimal range of LMA cuff pressure.\n\nBased on the concept of enhanced recovery after surgery (ERAS), this study will not only fill the current research gap but also provide solid support for safe and efficient perioperative airway management in elderly patients, effectively promoting further optimization of clinical practice, with important clinical significance and practical value.\n\nThis study is a prospective, single-center, randomized controlled clinical trial.\n\nIt aims to investigate the effects of continuous monitoring and progressive regulation of inflatable laryngeal mask airway (LMA) cuff pressure on postoperative pharyngolaryngeal complications such as sore throat and hoarseness in elderly patients, compared with conventional empirical LMA inflation. The composite outcome measure of this study includes the incidence of postoperative sore throat, hoarseness, supraglottic mucosal injury, blood on the LMA surface or in sputum, and dysphagia in subjects. Based on the results of preliminary pilot studies, the incidence of the composite outcome was 23.5% in the experimental group and 50% in the control group. With a two-sided α = 0.05 and a power of 90%, PASS 15.0 software was used to calculate the sample size: 65 cases in the experimental group (N1 = 65) and 65 cases in the control group (N2 = 65). Considering a 10% rate of loss to follow-up and refusal to participate, a minimum of 73 subjects were required in each group, with a total of at least 146 subjects to be enrolled. Subjects were randomly assigned to the experimental group or the control group using a random number table method.\n\nExperimental group (Pressure monitor + progressive cuff pressure regulation group): After the anesthesiologist performed empirical inflation of the LMA cuff, a pressure monitor was used for continuous monitoring and progressive regulation of the LMA cuff pressure throughout the procedure.\n\nControl group (Pressure monitor + no cuff pressure intervention group): After the same anesthesiologist performed empirical inflation of the LMA cuff, a pressure monitor was used for continuous monitoring of the LMA cuff pressure throughout the procedure, but no intervention was made on the cuff pressure. The anesthesiologist was blinded to the cuff pressure values.\n\nPrimary outcome measure: The composite outcome measure includes the incidence of postoperative sore throat, hoarseness, supraglottic mucosal injury, blood on the LMA surface or in sputum, and dysphagia in subjects.\n\nSecondary outcome measures: Grading of LMA insertion difficulty; number and duration of LMA insertion attempts (from the start of insertion to successful placement and verification); epiglottis morphology and LMA positioning score under bronchoscopy; other perioperative airway complications (e.g., laryngospasm, LMA displacement, hypoxemia); incidence of pulmonary complications within 7 days and 30 days after surgery; length of hospital stay and medical costs; patient satisfaction, etc.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged ≥ 60years;\n* Non-cardiac, non-thoracic, and non-head and neck surgery;\n* Non-laparoscopic surgery;\n* Elective surgery;\n* Surgical position: supine position ;\n* American Society of Anesthesiologists (ASA) physical status classification Ⅰ-Ⅲ;\n* New York Heart Association (NYHA) cardiac function classification Ⅰ-Ⅱ;\n* Expected surgical duration ≥30 minutes and ≤ 2 hours;\n* Body mass index (BMI) 18.5-30.0 kg/m2.\n\nExclusion Criteria:\n\n* Preoperative predictable difficult airways, such as trismus, limited neck mobility, and other related conditions;\n* Preoperative pharyngeal and laryngeal complications including sore throat, hoarseness, blood-tinged sputum, and dysphagia;\n* Preexisting conditions such as loose teeth, laryngeal obstruction, laryngeal edema, acute airway inflammation, and gastrointestinal bleeding;\n* Comorbidities of respiratory diseases like chronic obstructive pulmonary disease (COPD) and asthma;\n* Allergies to ILMA materials (e.g., silicone, polyvinylchloride \\[PVC\\]);\n* Inability to cooperate with the study for any reason;\n* Participation in other clinical trials within 3 months prior to enrollment in this study;\n* Any other circumstances deemed inappropriate for inclusion by the investigators.'}, 'identificationModule': {'nctId': 'NCT07461467', 'briefTitle': 'Effects of Continuous Monitoring and Progressive Regulation of Inflatable Laryngeal Mask Airway Cuff Pressure on Postoperative Pharyngolaryngeal Complications in Elderly Patients', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Chongqing Medical University'}, 'officialTitle': 'Effects of Continuous Monitoring and Progressive Regulation of Inflatable Laryngeal Mask Airway Cuff Pressure on Postoperative Pharyngolaryngeal Complications in Elderly Patients', 'orgStudyIdInfo': {'id': '2025-773-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Empirically inflated LMA', 'description': '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.', 'interventionNames': ['Other: Empirically inflated LMA']}, {'type': 'EXPERIMENTAL', 'label': 'Regulated and monitored ILMA', 'description': '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.', 'interventionNames': ['Other: Regulated and monitored ILMA']}], 'interventions': [{'name': 'Regulated and monitored ILMA', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Regulated and monitored ILMA']}, {'name': 'Empirically inflated LMA', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Empirically inflated LMA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400016', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Su Min', 'role': 'CONTACT', 'email': 'yangxuanqi1221@163.com', 'phone': '13408631952'}], 'facility': 'The First Affiliated Hospital of Chongqing Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'Su Min', 'role': 'CONTACT', 'email': 'yangxuanqi1221@163.com', 'phone': '13408631952'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital of Chongqing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Min Su', 'investigatorAffiliation': 'First Affiliated Hospital of Chongqing Medical University'}}}}