Clinical trial NCT06310941: Mechanical Insufflation-exsufflation and Hypertonic Saline in Nosocomial Bacterial Respiratory Tract Infection
Official title: Aspiration of Bronchial Secretions With Mechanical Insufflation-Exsufflation and Hypertonic Saline in Bacterial Nosocomial Tracheobronchitis and Pneumonia in Intubated Patients.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Nosocomial Infection
Nosocomial Pneumonia
Tracheobronchitis
Mechanical Ventilation Complication
Endotracheal Intubation
Keywords: mechanical insufflation-exsufflation
cough assist device
hypertonic saline
nosocomial respiratory tract infection
hospital-acquired pneumonia
tracheobronchitis
ventilator-associated pneumonia
nebulization
Lead sponsor: Hospital San Carlos, Madrid
Sponsor class: OTHER
Collaborators: name: FUNDACION PARA LA INVESTIGACION HOSPITAL CLINICO SAN CARLOS
First posted: 2024-03-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: multicenter, randomized, open label
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Nosocomial pneumonia (vHAP or VAP) or nosocomial tracheobronchitis
* Intubated with a cuffed endotracheal tube or tracheostomy cannula.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Median SOFA score increase >2 points on day 4
timeFrame: inclusion to day 4 after randomization
measure: Median respiratory support-free days increase at day 28
timeFrame: Inclusion to day 28 after randomization
measure: Percentage of subjects surviving/dying day 28
timeFrame: Inclusion to day 28 after randomization
Secondary outcomes:
measure: Subjects with bacterial eradication in respiratory samples at day 4 after randomization
timeFrame: Day 3 to 5 after randomization
measure: Subjects with bacterial eradication in respiratory samples at end of systemic antibiotic therapy
timeFrame: 7 and 14 days after randomization
measure: Median Length of ICU stay
timeFrame: ICU admission to discharge or death in days
measure: Median antibiotic-free days at 28 days
timeFrame: from study inclusion to day 28
Other outcomes:
Locations:
city: Tenerife
country: Spain
facility: Hospital Nuestra Señora de la Candelaria.
state: Las Palmas
city: Vigo
country: Spain
facility: Hospital Álvaro Cunqueiro.
state: Pontevedra
city: Barcelona
country: Spain
facility: Hospital Vall d´Hebrón.
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital de la Princesa
city: Madrid
country: Spain
facility: Hospital Doce de Octubre
city: Toledo
country: Spain
facility: Virgen de la Salud
Study officials:
affiliation: Hospial Clinico San Carlos
name: Belén De la Hera Hernanz, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.