Mechanical Insufflation-exsufflation and Hypertonic Saline in Nosocomial Bacterial Respiratory Tract Infection
Launched by HOSPITAL SAN CARLOS, MADRID · Mar 12, 2024
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a combination of two treatments—mechanical insufflation-exsufflation (IEM) and hypertonic saline (HS)—for patients who have developed lung infections while in the hospital, especially those who are on artificial ventilation in the intensive care unit (ICU). The goal is to find out if clearing out infected mucus through suctioning (aspiration) and using nebulized hypertonic saline can help patients recover from these serious lung infections more effectively than just using antibiotics alone.
To participate in this trial, patients must be between 65 and 74 years old and have a specific type of lung infection known as nosocomial pneumonia or tracheobronchitis, and they must be intubated (having a breathing tube). Participants will be asked to sign a consent form, and they will receive either the new treatment combination or standard care. It’s important to note that certain patients with severe health issues, such as those with unstable conditions or significant lung complications, will not be eligible for the study. This research is still in the planning stages and has not started recruiting participants yet.
Gender
ALL
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
About Hospital San Carlos, Madrid
Hospital San Carlos, located in Madrid, is a leading healthcare institution renowned for its commitment to advancing medical research and improving patient outcomes. As a prominent clinical trial sponsor, the hospital is dedicated to conducting innovative studies that adhere to the highest ethical and scientific standards. With a multidisciplinary team of experienced researchers and clinicians, Hospital San Carlos aims to explore novel therapeutic approaches and contribute to the development of cutting-edge treatments across various medical fields. Its strategic collaborations and robust infrastructure enable the hospital to effectively facilitate clinical trials, ultimately enhancing the quality of care provided to patients.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Tenerife, Las Palmas, Spain
Vigo, Pontevedra, Spain
Barcelona, , Spain
Toledo, , Spain
Patients applied
Trial Officials
Belén De la Hera Hernanz, PhD
Study Director
Hospial Clinico San Carlos
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported