Mechanical Insufflation-exsufflation and Hypertonic Saline in Nosocomial Bacterial Respiratory Tract Infection (ABSENTA)

San Carlos Clinical Hospital

Status: Not yet enrolling

Conditions: Nosocomial Infection; Mechanical Ventilation Complication; Tracheobronchitis; Nosocomial Pneumonia; Endotracheal Intubation

Treatments: Device: Mechanical insufflation-exsufflation; Other: Hypertonic saline with hyaluronic acid; Other: Standard of Care

Study type: Interventional

Funder types: Other

Identifiers

NCT06310941

Pending

ABSENTA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

Standard of Care

Active Comparator group

Description:

Standard of care: Systemic antibiotic therapy according to local protocol and at the discretion of the attending intensivist.

Treatment:

Other: Standard of Care

Mechanical insufflation-exsufflation with hypertonic saline/hyaluronic acid comination

Experimental group

Description:

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%).

Treatment:

Other: Hypertonic saline with hyaluronic acid

Device: Mechanical insufflation-exsufflation

Mechanical insufflation-exsufflation

Experimental group

Description:

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)

Treatment:

Device: Mechanical insufflation-exsufflation