Mechanical Insufflation-exsufflation and Hypertonic Saline in Nosocomial Bacterial Respiratory Tract Infection
ABSENTA
Aspiration of Bronchial Secretions With Mechanical Insufflation-Exsufflation and Hypertonic Saline in Bacterial Nosocomial Tracheobronchitis and Pneumonia in Intubated Patients.
2 other identifiers
interventional
100
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2026
Typical duration for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2024
CompletedFirst Posted
Study publicly available on registry
March 15, 2024
CompletedStudy Start
First participant enrolled
January 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2027
March 26, 2025
March 1, 2025
1.5 years
February 27, 2024
March 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Secondary Outcomes (4)
Subjects with bacterial eradication in respiratory samples at day 4 after randomization
Day 3 to 5 after randomization
Subjects with bacterial eradication in respiratory samples at end of systemic antibiotic therapy
7 and 14 days after randomization
Median Length of ICU stay
ICU admission to discharge or death in days
Median antibiotic-free days at 28 days
from study inclusion to day 28
Study Arms (3)
Standard of Care
ACTIVE COMPARATORStandard of care: Systemic antibiotic therapy according to local protocol and at the discretion of the attending intensivist.
Mechanical insufflation-exsufflation with hypertonic saline/hyaluronic acid comination
EXPERIMENTALSystemic 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
EXPERIMENTALSystemic 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)
Interventions
Combined use of mechanical insufflation-exsufflation with nebulized hypertonic saline in intubated patients with nosocomial respiratory tract infection
systemic antibiotic therapy and catheter suctioning of secretions as recommended by guidelines
Commercially available combination of 7% hypertonic saline with 0.1% hyaluronic acid given as nebulization during the MI-E session
Eligibility Criteria
You may qualify if:
- Signed informed consent
- Nosocomial pneumonia (vHAP or VAP) or nosocomial tracheobronchitis
- Intubated with a cuffed endotracheal tube or tracheostomy cannula.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
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, 28040, Spain
Hospital Clínico San Carlos
Madrid, Madrid, 28040, 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
Related Publications (4)
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.
PMID: 38307525BACKGROUNDFerreira 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.
PMID: 30018175BACKGROUNDKnudtzen 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.
PMID: 33027229BACKGROUNDSanchez-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.
PMID: 29616357BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Belén De la Hera Hernanz, PhD
Hospial Clinico San Carlos
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Emeritus Critical Care Department
Study Record Dates
First Submitted
February 27, 2024
First Posted
March 15, 2024
Study Start
January 1, 2026
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
December 30, 2027
Last Updated
March 26, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- After study publication
- Access Criteria
- Anonymyzed data sheet of all subjects and variables for a pre-specified analysis plan.
Anonymyzed data sheet of all subjects and variables for a pre-specified analysis plan.