The included population consists of patients at high risk of reflux/aspiration and expected to require mechanical ventilation for more than 72 hours, including recurrent laryngeal nerve injury, cerebral infarction/cerebral hemorrhage (new-onset + residual swallowing dysfunction from previous), craniocerebral surgery/traumatic brain injury (TBI), neuromuscular (junction) diseases (myasthenia gravis
Conditions
Interventions
AG group:AnapnoGuard
Control group:Conventional airway management
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >= 18 years old; 2.Undergoing tracheal intubation or tracheotomy; 3.Expected mechanical ventilation time greater than 72 hours; 4.Meet one of the high-risk factors for reflux/aspiration: recurrent laryngeal nerve injury, cerebral infarction/cerebral hemorrhage (new onset + residual swallowing dysfunction from the past), craniocerebral surgery/traumatic brain injury (TBI), neuromuscular (junction) diseases (myasthenia gravis, malnutrition, Parkinson's disease, and other diseases that can weaken the strength and coordination of swallowing muscles), continuous use of muscle relaxants during mechanical ventilation for >= 48 hours, ICU-acquired myopathy, ICU-acquired weakness, gastroparesis (gastric residual volume > 500 mL/6h), consciousness disorder; 5.The subject or legal representative voluntarily participates in this study and signs the informed consent form;
Exclusion criteria
Exclusion criteria: 1.Expected duration of mechanical ventilation less than 48 hours; 2.Pregnant or lactating women; 3.Patients with tracheoesophageal or bronchopleural fistula; 4.Patients with difficult intubation (more than three attempts), regurgitation and aspiration during intubation (lung injury and secondary pulmonary infection); 5.Patients with irreversible disease, end-stage state, and expected death in the near future; 6.Patients with confirmed VAP were excluded from hospital acquired pneumonia; 7.Patients participating in other clinical trials who are expected to have an effect on the results of this trial; 8.Patients who were judged by the investigator to be ineligible for enrollment;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Days without ventilator-associated lower respiratory tract infection within 28 days; | — |
Secondary
| Measure | Time frame |
|---|---|
| Days without mechanical ventilation within 28 days;Length of ICU stay;AE;Total length of stay;FeNO;Days of antibiotic use;Mortality;Defined Daily Dose; | — |
Countries
China
Contacts
Public ContactMing Zhong
Zhongshan Hospital, Fudan University
Outcome results
None listed