Mechanical Insufflation-exsufflation and Hypertonic Saline in Nosocomial Bacterial Respiratory Tract Infection
NCT ID: NCT06310941
Last Updated: 2025-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
100 participants
INTERVENTIONAL
2026-01-01
2027-12-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard of Care
Standard of care: Systemic antibiotic therapy according to local protocol and at the discretion of the attending intensivist.
Standard of Care
systemic antibiotic therapy and catheter suctioning of secretions as recommended by guidelines
Mechanical insufflation-exsufflation with hypertonic saline/hyaluronic acid comination
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
Combined use of mechanical insufflation-exsufflation with nebulized hypertonic saline in intubated patients with nosocomial respiratory tract infection
Hypertonic saline with hyaluronic acid
Commercially available combination of 7% hypertonic saline with 0.1% hyaluronic acid given as nebulization during the MI-E session
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
Combined use of mechanical insufflation-exsufflation with nebulized hypertonic saline in intubated patients with nosocomial respiratory tract infection
Interventions
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Mechanical insufflation-exsufflation
Combined use of mechanical insufflation-exsufflation with nebulized hypertonic saline in intubated patients with nosocomial respiratory tract infection
Standard of Care
systemic antibiotic therapy and catheter suctioning of secretions as recommended by guidelines
Hypertonic saline with hyaluronic acid
Commercially available combination of 7% hypertonic saline with 0.1% hyaluronic acid given as nebulization during the MI-E session
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Nosocomial pneumonia (vHAP or VAP) or nosocomial tracheobronchitis
* Intubated with a cuffed endotracheal tube or tracheostomy cannula.
Exclusion Criteria
* Frank hemoptisis
* Barotrauma (pneumothorax or pneumomediastinum)
* Bronchospasm (patients on bronchodilators for previous bronchospasm may be included
* Unstable thoracic cage
* Suspected unmonitored intracraneal hypertension
18 Years
ALL
No
Sponsors
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FUNDACION PARA LA INVESTIGACION HOSPITAL CLINICO SAN CARLOS
OTHER
Hospital San Carlos, Madrid
OTHER
Responsible Party
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Miguel Sanchez Garcia
Emeritus Critical Care Department
Principal Investigators
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Belén De la Hera Hernanz, PhD
Role: STUDY_DIRECTOR
Hospial Clinico San Carlos
Locations
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Hospital Vall d´Hebrón.
Barcelona, Barcelona, Spain
Hospital Nuestra Señora de la Candelaria.
Santa Cruz de Tenerife, Las Palmas, Spain
Hospital Clinico San Carlos
Madrid, Madrid, Spain
Hospital Clínico San Carlos
Madrid, Madrid, Spain
Hospital de la Princesa
Madrid, Madrid, Spain
Hospital Doce de Octubre
Madrid, Madrid, Spain
Hospital Álvaro Cunqueiro.
Vigo, Pontevedra, Spain
Virgen de la Salud
Toledo, Toledo, Spain
Countries
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Central Contacts
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Facility Contacts
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Xavier - Nuvials, MD, PhD
Role: primary
Ricard - Ferrer Roca, MD, PhD
Role: backup
Sergio - Rodríguez Ramos, MD
Role: primary
Aris - Pérez Lucendo
Role: primary
Dolores - Rodríguez Huerta
Role: backup
María Cruz - Martín-Delgado, MD
Role: primary
Pilar Losada, MD, PhD
Role: primary
Dolores Vila, MD, PhD
Role: backup
Gonzalo Hernández, MD, PhD
Role: primary
References
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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.
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.
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.
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.
Other Identifiers
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Pending
Identifier Type: OTHER
Identifier Source: secondary_id
ABSENTA
Identifier Type: -
Identifier Source: org_study_id
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