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| ID | Type | Description | Link |
|---|---|---|---|
| Pending | Other Identifier | Ceim HCSC (ERB of Hospital Clinico San Carlos)) |
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| Name | Class |
|---|---|
| FUNDACION PARA LA INVESTIGACION HOSPITAL CLINICO SAN CARLOS | OTHER |
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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.
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:
If the diagnosis is tracheobronchitis,subjects will be randomization to one of 3 study groups:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Active Comparator | Standard of care: Systemic antibiotic therapy according to local protocol and at the discretion of the attending intensivist. |
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| Mechanical insufflation-exsufflation with hypertonic saline/hyaluronic acid comination | Experimental | 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 | Experimental | 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mechanical insufflation-exsufflation | Device | Combined use of mechanical insufflation-exsufflation with nebulized hypertonic saline in intubated patients with nosocomial respiratory tract infection |
| Measure | Description | Time Frame |
|---|---|---|
| Median SOFA score increase >2 points on day 4 | Increase in organ dysfunction score from baseline to day 4 after randomization. | inclusion to day 4 after randomization |
| Median respiratory support-free days increase at day 28 | 28 minus duration in days on high-flow nasal cannula + invasive ventilation. | Inclusion to day 28 after randomization |
| Percentage of subjects surviving/dying day 28 | crude mortality on day 28 after randomization | Inclusion to day 28 after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Subjects with bacterial eradication in respiratory samples at day 4 after randomization | Negative tests for causal microorganism in day 4 samples | Day 3 to 5 after randomization |
| Subjects with bacterial eradication in respiratory samples at end of systemic antibiotic therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Miguel Sánchez Garcia, MD. PhD. | Contact | +34658762739 | miguelsanchez.hcsc@gmail.com | |
| Belén De la Hera Hernanz, PhD | Contact | +34650624550 | belenhhernanz@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Belén De la Hera Hernanz, PhD | Hospial Clinico San Carlos | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Vall d´Hebrón. | Barcelona | Barcelona | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30018175 | Background | Ferreira de Camillis ML, Savi A, Goulart Rosa R, Figueiredo M, Wickert R, Borges LGA, Galant L, Teixeira C. Effects of Mechanical Insufflation-Exsufflation on Airway Mucus Clearance Among Mechanically Ventilated ICU Subjects. Respir Care. 2018 Dec;63(12):1471-1477. doi: 10.4187/respcare.06253. Epub 2018 Jul 17. | |
| 33027229 | Background |
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Anonymyzed data sheet of all subjects and variables for a pre-specified analysis plan.
After study publication
Anonymyzed data sheet of all subjects and variables for a pre-specified analysis plan.
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multicenter, randomized, open label
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| Standard of Care | Other | systemic antibiotic therapy and catheter suctioning of secretions as recommended by guidelines |
|
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| Hypertonic saline with hyaluronic acid | Other | Commercially available combination of 7% hypertonic saline with 0.1% hyaluronic acid given as nebulization during the MI-E session |
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Negative culture and molecular test for causative bacteria in samples at end of therapy |
| 7 and 14 days after randomization |
| Median Length of ICU stay | Duration of ICU stay from admission to discharge or death | ICU admission to discharge or death in days |
| Median antibiotic-free days at 28 days | 28 minus days without systemic antibiotic therapy | from study inclusion to day 28 |
| Hospital Nuestra Señora de la Candelaria. | Santa Cruz de Tenerife | Las Palmas | Spain |
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| Hospital Clinico San Carlos | Madrid | Madrid | 28040 | Spain |
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| Hospital Clínico San Carlos | Madrid | Madrid | 28040 | Spain |
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| Hospital de la Princesa | Madrid | Madrid | Spain |
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| Hospital Doce de Octubre | Madrid | Madrid | Spain |
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| Hospital Álvaro Cunqueiro. | Vigo | Pontevedra | Spain |
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| Virgen de la Salud | Toledo | Toledo | Spain |
|
| Knudtzen FC, Sprehn M, Vestbo J, Johansen IS. Mechanical insufflation/exsufflation compared with standard of care in patients with pneumonia: A randomised controlled trial. Eur J Anaesthesiol. 2020 Nov;37(11):1077-1080. doi: 10.1097/EJA.0000000000001209. No abstract available. |
| 29616357 | Background | Sanchez-Garcia M, Santos P, Rodriguez-Trigo G, Martinez-Sagasti F, Farina-Gonzalez T, Del Pino-Ramirez A, Cardenal-Sanchez C, Busto-Gonzalez B, Requesens-Solera M, Nieto-Cabrera M, Romero-Romero F, Nunez-Reiz A. Preliminary experience on the safety and tolerability of mechanical "insufflation-exsufflation" in subjects with artificial airway. Intensive Care Med Exp. 2018 Apr 3;6(1):8. doi: 10.1186/s40635-018-0173-6. |
| 38307525 | Result | Sanchez-Garcia M, Alvarez-Gonzalez M, Domingo-Marin S, Pino-Ramirez AD, Martinez-Sagasti F, Gonzalez-Arenas P, Cardenal-Sanchez C, Velasco-Lopez E, Nunez-Reiz A. Comparison of Mechanical Insufflation-Exsufflation and Hypertonic Saline and Hyaluronic Acid With Conventional Open Catheter Suctioning in Intubated Patients. Respir Care. 2024 Apr 22;69(5):575-585. doi: 10.4187/respcare.11566. |
| ID | Term |
|---|---|
| D003428 | Cross Infection |
| D000077299 | Healthcare-Associated Pneumonia |
| D053717 | Pneumonia, Ventilator-Associated |
| ID | Term |
|---|---|
| D007239 | Infections |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| D012462 | Saline Solution, Hypertonic |
| D006820 | Hyaluronic Acid |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D006982 | Hypertonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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