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Search / Trial NCT06310941

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

Mechanical Insufflation Exsufflation Cough Assist Device Hypertonic Saline Nosocomial Respiratory Tract Infection Hospital Acquired Pneumonia Tracheobronchitis Ventilator Associated Pneumonia Nebulization

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.

Locations

Madrid, , Spain

Madrid, , Spain

Madrid, , Spain

Madrid, , Spain

Tenerife, Las Palmas, Spain

Vigo, Pontevedra, Spain

Barcelona, , Spain

Toledo, , Spain

Patients applied

0 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