Mechanical Insufflation-exsufflation and Hypertonic Saline in Nosocomial Bacterial Respiratory Tract Infection
- Conditions
- Nosocomial InfectionTracheobronchitisMechanical Ventilation ComplicationEndotracheal IntubationNosocomial Pneumonia
- Interventions
- Other: Standard of CareDevice: Mechanical insufflation-exsufflationOther: Hypertonic saline with hyaluronic acid
- Registration Number
- NCT06310941
- Lead Sponsor
- Hospital San Carlos, Madrid
- Brief Summary
Multicenter, randomized open label clinical trial to evaluate IEM and HS as concomitant therapy for respiratory tract infection in patients under artificial ventilation in the ICU.
Lung infection is a serious complication that may occur during hospital stay and may need artificial respiration or even develop during artificial ventilation for other causes.
Current specific treatment consists of intravenous antibiotics. The current study evaluated whether aspiration and drainage of infected sputum helps curing this severe complication and whether nebulized HS has additional benefits, like loosening of secretions, eradicating bacteria or reducing inflammation.
- Detailed Description
Open label, randomized, multicenter (7 ICUs at 7 hospitals in Spain). The study has 2 main arms, pneumonia and tracheobronchitis.
If the diagnosis is pneumonia, subjects will be randomization to one of 3 study groups:
1. IV Antibiotic therapy
2. IV Antibiotic therapy + mechanical insufflation-Exsugglation (MI-E)
3. IV Antibiotic therapy + MI-E + nebulized hypertonic saline-hyaluronic acid (HS)
If the diagnosis is tracheobronchitis,subjects will be randomization to one of 3 study groups:
1. No specific therapy (recommendation of the Infectious Diseases Society of America)
2. IV Antibiotic therapy (common practice to prevent progressión to pneumona and shorten duration of intubation)
3. MI-E + HS
Safety will be compared by number of adverse events, severe adverse events and mortality between study groups in each main arm. Efficacy will be compared by duration of respiratory support and number of cases with worsening organ dysfunction.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- Signed informed consent
- Nosocomial pneumonia (vHAP or VAP) or nosocomial tracheobronchitis
- Intubated with a cuffed endotracheal tube or tracheostomy cannula.
- Ominous prognosis
- Frank hemoptisis
- Barotrauma (pneumothorax or pneumomediastinum)
- Bronchospasm (patients on bronchodilators for previous bronchospasm may be included
- Unstable thoracic cage
- Suspected unmonitored intracraneal hypertension
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard of Care Standard of Care Standard of care: Systemic antibiotic therapy according to local protocol and at the discretion of the attending intensivist. Mechanical insufflation-exsufflation with hypertonic saline/hyaluronic acid comination Mechanical insufflation-exsufflation Systemic antibiotic therapy choice according to local protocol and at the discretion of the attending intensivist plus Mechanical insufflation-exsufflation (MI-E sessión tid during the first 48 hours, followed by MI-E if secretions are present or suspected; recommended settings +50 cmH2O/-50 cmH2O) with simultaneous nebulization of hypertonic saline (7%) with hyaluronic acid (0.1%). Mechanical insufflation-exsufflation Mechanical insufflation-exsufflation Systemic antibiotic therapy choice according to local protocol and at the discretion of the attending intensivist plus Mechanical insufflation-exsufflation (MI-E sessión tid during the first 48 hours, followed by MI-E if secretions are present or suspected; recommended settings +50 cmH2O/-50 cmH2O) Mechanical insufflation-exsufflation with hypertonic saline/hyaluronic acid comination Hypertonic saline with hyaluronic acid Systemic antibiotic therapy choice according to local protocol and at the discretion of the attending intensivist plus Mechanical insufflation-exsufflation (MI-E sessión tid during the first 48 hours, followed by MI-E if secretions are present or suspected; recommended settings +50 cmH2O/-50 cmH2O) with simultaneous nebulization of hypertonic saline (7%) with hyaluronic acid (0.1%).
- Primary Outcome Measures
Name Time Method Median respiratory support-free days increase at day 28 Inclusion to day 28 after randomization 28 minus duration in days on high-flow nasal cannula + invasive ventilation.
Percentage of subjects surviving/dying day 28 Inclusion to day 28 after randomization crude mortality on day 28 after randomization
Median SOFA score increase >2 points on day 4 inclusion to day 4 after randomization Increase in organ dysfunction score from baseline to day 4 after randomization.
- Secondary Outcome Measures
Name Time Method Subjects with bacterial eradication in respiratory samples at day 4 after randomization Day 3 to 5 after randomization Negative tests for causal microorganism in day 4 samples
Subjects with bacterial eradication in respiratory samples at end of systemic antibiotic therapy 7 and 14 days after randomization Negative culture and molecular test for causative bacteria in samples at end of therapy
Median Length of ICU stay ICU admission to discharge or death in days Duration of ICU stay from admission to discharge or death
Median antibiotic-free days at 28 days from study inclusion to day 28 28 minus days without systemic antibiotic therapy
Trial Locations
- Locations (8)
Hospital Clínico San Carlos
🇪🇸Madrid, Spain
Hospital Nuestra Señora de la Candelaria.
🇪🇸Tenerife, Las Palmas, Spain
Hospital Álvaro Cunqueiro.
🇪🇸Vigo, Pontevedra, Spain
Hospital Vall d´Hebrón.
🇪🇸Barcelona, Spain
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Hospital de la Princesa
🇪🇸Madrid, Spain
Hospital Doce de Octubre
🇪🇸Madrid, Spain
Virgen de la Salud
🇪🇸Toledo, Spain