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Effects of Continuous Monitoring and Progressive Regulation of Inflatable Laryngeal Mask Airway Cuff Pressure on Postoperative Pharyngolaryngeal Complications in Elderly Patients

ConditionsElderly (People Aged 65 or More)LMARandomized Controlled TrialLaryngeal Mask AirwaysPharyngolaryngeal Postoperative PainCuff PressureOropharyngeal Leak Pressure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorFirst Affiliated Hospital of Chongqing Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged ≥ 60years;

Non-cardiac, non-thoracic, and non-head and neck surgery;

Non-laparoscopic surgery;

Elective surgery;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Regulated and monitored ILMA

    Other intervention

    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.

  • Empirically inflated LMA

    Other intervention

    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.

Treatment groups

146 Participants
are divided into 2 treatment groups
Group A: Empirically inflated LMAActive comparator 1 intervention
Group B: Regulated and monitored ILMAExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The incidence of postoperative pharyngeal pain

Pharyngeal pain was evaluated using the Visual Analogue Scale (VAS), with a score ≥ 3 defined as the occurrence of pharyngeal pain.

Time frame
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.
2

The incidence of postoperative supraglottic pharyngeal mucosal injury

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.

Time frame
Baseline (before LMA insertion)；Intraoperative (at LMA insertion)；Intraoperative (at LMA removal)
3

The incidence of postoperative hoarseness

Hoarseness was graded according to a hoarseness severity scale, with a grade ≥ 1 defined as the occurrence of hoarseness.

Time frame
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.
4

The incidence of postoperative blood on the laryngeal mask airway (LMA) surface or in sputum

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.

Time frame
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.

Secondary outcomes

1

The incidence of other perioperative airway complications

such as laryngospasm, LMA displacement, hypoxemia

Time frame
Within 7 days postoperatively
2

Incidence of pulmonary complications

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. Definitions: The diagnosis of respiratory tract infection, pulmonary infection, atelectasis, pulmonary embolism, acute lung injury, and aspiration pneumonia requires clear clinical history and supporting imaging findings. The diagnosis of ARDS is based on the Berlin definition.

Time frame
within 7 days and 30 days postoperatively
3

Patient satisfaction

Patient satisfaction was evaluated using a 5-point Likert scale, covering multiple dimensions including perioperative comfort, postoperative recovery, and investigator attitude. Scores ranged from 1 to 5, with responses graded as very satisfied (5), satisfied (4), neutral (3), dissatisfied (2), and very dissatisfied (1).

Time frame
On postoperative day 3

Other outcomes

Sponsors and contacts

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First Affiliated Hospital of Chongqing Medical University

Lead sponsor

Source ClinicalTrials.gov
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