Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06310941

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Nosocomial Infection Cross Infection Disease Attributes Endotracheal Intubation Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Mechanical Ventilation Complication Nosocomial Pneumonia Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Ventilator-Associated Respiratory Tract Diseases Respiratory Tract Infections Tracheobronchitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Vall d´Hebrón., Barcelona, Spain

Loading trial locations.

About this study

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:

  • IV Antibiotic therapy
  • IV Antibiotic therapy + mechanical insufflation-Exsugglation (MI-E)
  • 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:

  • No specific therapy (recommendation of the Infectious Diseases Society of America)
  • IV Antibiotic therapy (common practice to prevent progressión to pneumona and shorten duration of intubation)
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mechanical insufflation-exsufflation

Device

Combined use of mechanical insufflation-exsufflation with nebulized hypertonic saline in intubated patients with nosocomial respiratory tract infection

Other names: Cough Assist

Standard of care

Other

systemic antibiotic therapy and catheter suctioning of secretions as recommended by guidelines

Other names: Routine care of respiratory tract infection

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

Other names: (Hyaneb-TM)

Primary outcomes

  1. Median SOFA score increase >2 points on day 4

    Time frame: inclusion to day 4 after randomization

    Increase in organ dysfunction score from baseline to day 4 after randomization.

  2. Median respiratory support-free days increase at day 28

    Time frame: Inclusion to day 28 after randomization

    28 minus duration in days on high-flow nasal cannula + invasive ventilation.

  3. Percentage of subjects surviving/dying day 28

    Time frame: Inclusion to day 28 after randomization

    crude mortality on day 28 after randomization

Secondary outcomes

  1. Subjects with bacterial eradication in respiratory samples at day 4 after randomization

    Time frame: Day 3 to 5 after randomization

    Negative tests for causal microorganism in day 4 samples

  2. Subjects with bacterial eradication in respiratory samples at end of systemic antibiotic therapy

    Time frame: 7 and 14 days after randomization

    Negative culture and molecular test for causative bacteria in samples at end of therapy

  3. Median Length of ICU stay

    Time frame: ICU admission to discharge or death in days

    Duration of ICU stay from admission to discharge or death

  4. Median antibiotic-free days at 28 days

    Time frame: from study inclusion to day 28

    28 minus days without systemic antibiotic therapy

Study contacts

Contact information is provided by the study sponsor or research team.

Belén De la Hera Hernanz, PhD

CONTACT

[email protected]

+34650624550

Miguel Sánchez Garcia, MD. PhD.

CONTACT

[email protected]

+34658762739

Sponsors and collaborators

Lead sponsor

Hospital San Carlos, Madrid

Other

Collaborators

  • FUNDACION PARA LA INVESTIGACION HOSPITAL CLINICO SAN CARLOS

Registry information

Official study title

Aspiration of Bronchial Secretions With Mechanical Insufflation-Exsufflation and Hypertonic Saline in Bacterial Nosocomial Tracheobronchitis and Pneumonia in Intubated Patients.

Acronym: ABSENTA

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 15, 2024
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.