Impaired airway clearance in patients on invasive mechanical ventilation
Conditions
Interventions
Test:Mechanically assisted sputum evacuation with the test product T6 pro cough simulated ventilator monitor
Control:Assisted expectoration with the control product P30 High Frequency Vibratory Expectorator
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: (1) Age = 18 years ; (2) Mechanically ventilated patients with an established artificial airway (endotracheal intubation or tracheotomy) who are expected to be mechanically ventilated for at least 3 days; (3) Stable haemodynamic and respiratory function 24 hours after admission, and meeting the following criteria: ? Heart rate >40 beats/min or <120 beats/min; and ? Systolic blood pressure (SBP) =90 mmHg or =180 mmHg, or/and diastolic blood pressure (DBP) =110 mmHg, and mean arterial pressure (MBP) =65 mmHg or =110 mmHg; ? Respiratory rate =25 breaths/min; oxygen saturation =90%, mechanical ventilation inspired oxygen concentration (FIO2) =60% , positive end-expiratory pressure (PEEP) =10 cmH2O; ? Support with low-dose vasoactive drugs, dopamine =10 ug/(kg-mi) or norepinephrine/epinephrine =0.1 ug/(kg-min); (4) Presence of impaired airway clearance [6,7] with one of the following conditions: ? Ciliary mucus system impairment and changes in the nature of the mucus, such as the presence of chronic airway diseases (chronic obstructive pulmonary disease, bronchial asthma, diffuse panuberculous bronchitis, bronchiectasis, cystic fibrosis, etc.), lung parenchymal injuries (pneumonia, ARDS, etc.), interstitial lung diseases (interstitial fibrosis, etc.), congenital chronic airway diseases (primary cilium dyskinesia, etc.), infections (bacterial infections, viral infection, fungal infection, etc.); ? Altered airway resistance, such as chronic obstructive pulmonary disease, chronic bronchitis, bronchial asthma, etc; ? Cough dysfunction or impairment, such as the use of anaesthesia, sedation, analgesia, muscarinic drugs, the presence of neuromuscular diseases (Guillain-Barré syndrome, myasthenia gravis, myotonic dystrophy, lateral sclerosis syndrome of the spinal cord, Parkinson's disease, ICU-acquired debilitation, etc.), cerebrovascular disease (stroke, craniocerebral injuries, etc.), surgical procedures (abdominal, lumbar spine surgery, etc.); (5) The subject or his/her legal representative has signed an informed consent form.
Exclusion criteria
Exclusion criteria: (1) Subjects with contraindications to mechanically assisted sputum evacuation: ? Pneumothorax or mediastinal emphysema without drainage; ? Vital signs are unstable; ? New acute coronary syndrome, fatal arrhythmia, acute left heart failure; ? Unstable deep vein thrombosis, pulmonary embolism, intracardiac appendage thrombosis; ? Acute cerebrovascular lesions, intracranial injury; (2) Subjects with contraindications to high-frequency chest wall oscillation: ? Chest wall injury, chest wall instability or recent thoracic surgery; ? Pneumothorax or mediastinal emphysema without drainage; ? Unstable vital signs; ? New acute coronary syndrome, fatal arrhythmia, acute left heart failure; ? Unstable deep vein thrombosis, pulmonary embolism, intracardiac appendage thrombosis; ? Acute cerebrovascular lesions, intracranial injuries; ? Unstable cervical spine fracture or spinal cord injury; ? Deterioration of neurological function requiring intracranial pressure monitoring and ventricular drainage; ? Lactating women or pregnant women; (3) Others who are considered by the investigator to be unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average daily sputum output over three days of treatment;Incidence (%) and frequency (number in hours) of device-related adverse events AEs; | — |
Secondary
| Measure | Time frame |
|---|---|
| Average number of sputum aspirations per day;Arterial blood partial pressure of oxygen (PaO2), arterial blood partial pressure of carbon dioxide (PaCO2), and arterial blood pH difference before and after the second treatment daily;End-expiratory lung impedance before and after the second treatment of the day;Difference in airway resistance and lung compliance before and after each treatment session;Actual peak expiratory flow rate at each treatment setting of negative pressure and assisted sputum treatment in the test group;Incidence (%) and frequency (number in hours) of any adverse events;Respiratory rate, heart rate, blood pressure; | — |
Countries
China
Contacts
Public ContactNing Shen
Peking University Third Hospital
Outcome results
None listed