Elderly Heart Valve Surgery, Silent Aspiration
Conditions
Keywords
Elderly heart valve surgery, Silent aspiration, Interference electrical stimulation
Brief summary
Objective To investigate the safety and effectiveness of interference electrical stimulation in the prevention of silent aspiration after heart valve surgery in elderly patients. Silent aspiration was diagnosed when either pepsin level \>200 ng/ml or α-amylase level \>1685 U/L was detected in airway secretions.
Detailed description
In this study, a randomized controlled trial was conducted in elderly patients undergoing heart valve surgery at Fujian Medical University Union Hospital. Patients were selected according to the inclusion and exclusion criteria and randomly allocated to either the experimental group (routine nursing + interference electrical stimulation) or the control group (routine nursing + blank stimulation). Silent aspiration was diagnosed when either pepsin level \>200 ng/ml or α-amylase level \>1685 U/L was detected in airway secretions. Airway secretions were collected upon ICU admission after surgery, every 12 hours thereafter (depending on endotracheal tube indwelling time), before extubation, 24 hours after extubation, and on day 6 after surgery. The incidence of silent aspiration, swallowing function, clinical pulmonary infection score, mechanical ventilation duration, ICU length of stay, total hospital stay, and adverse events were compared between the two groups.
Interventions
DEVICEThe intervention was delivered using the Gentle Stim Electrical Stimulation Therapy Device (Model: JC-2071)
Prior to the intervention, the patient's skin was inspected for symptoms such as redness, swelling, or ulceration, and cleansed with an alcohol swab. The leads of the Gentle Stim electrical stimulation therapy device were checked to ensure they were safe and unobstructed. After resetting all settings to zero, the device was switched on. Electrode pads were attached, with two pairs of electrodes placed on the upper and lower lateral aspects of the thyroid cartilage, spaced 4 cm apart, and properly secured. The stimulation intensity was adjusted: one pair of electrodes was set to an output of 2050 Hz, and the other pair to 2000 Hz. The current was set between 2 and 2.5 mA.
OTHERUsual Care Group
A sham intervention was performed using the Gentle Stim electrical stimulation therapy device. The device was applied identically to the experimental group but without delivering any electrical current. The wearing duration was consistent with that of the experimental group.
Sponsors
Fujian Medical University Union Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Simple valve surgery * Age ≥60 years old * NYHA cardiac function Grade II-III * ASA Grade II-III * No dysphagia screened by SSA before surgery
Exclusion criteria
* Vocal cord dysfunction, oropharyngeal malignancies, or neck surgery affecting swallowing function * Postoperative hemodynamic instability and active bleeding * COPD, asthma, chronic bronchitis, lung cancer or other respiratory diseases * Previous gastroesophageal reflux disease * Serious mental or neurological disease * Skin damage or electrode allergy at the stimulation site * Implanted cardiac pacemaker * Participation in other interventional studies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| α-Amylase Level in Airway Secretions | Upon admission to ICU after surgery, every 12 hours thereafter (depending on endotracheal catheter indwelling time), before extubation, 24 hours after extubation, 6 days after surgery. | α-Amylase level in airway secretions was measured as a biomarker for silent aspiration. A level \>1685 U/L was considered positive for silent aspiration. |
| Pepsin Level in Airway Secretions | Upon admission to ICU after surgery, every 12 hours thereafter (depending on endotracheal catheter indwelling time), before extubation, 24 hours after extubation, 6 days after surgery. | Pepsin level in airway secretions was measured as a biomarker for silent aspiration. A level \>200 ng/ml was considered positive for silent aspiration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mechanical Ventilation Duration | During the ICU stay, assessed at the time of extubation. | Total duration of postoperative mechanical ventilation, measured in hours, from the time of ICU admission after surgery (initiation of mechanical ventilation) to the time of successful extubation. |
Countries
China
Outcome results
None listed