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Search / Trial NCT07017205

Microaspiration and Endotracheal Tubes

Launched by ARGENTINIAN INTENSIVE CARE SOCIETY · Jun 4, 2025

Trial Information

Current as of July 09, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is examining how well two different types of endotracheal tubes (ETTs) can prevent a problem called microaspiration during surgeries that require general anesthesia. Microaspiration occurs when secretions from the mouth accidentally leak past the cuff of the ETT into the lungs, which can lead to serious respiratory issues like pneumonia. The study will compare a traditional ETT with a newer model that has special features designed to help reduce this risk. A total of 144 adult patients scheduled for surgeries lasting at least one hour will be involved, and they will be randomly assigned to receive one of the two tubes. Researchers will look for signs of microaspiration by using a blue dye and will also monitor patients for any pain or voice changes after their surgery.

To participate in this study, patients must be adults over 18 years old and scheduled for a surgery that lasts at least an hour. They should be in good general health (classified as ASA I-III) and agree to take part in the trial by signing consent forms. However, patients with certain airway problems or those who might have a difficult time being intubated won't be included. Throughout the trial, participants can expect to have their tracheal secretions tested for the blue dye and their cuff pressure monitored if they receive the newer tube. This research aims to find out which type of tube is better at keeping patients safe during surgery and will help doctors make informed choices in the future.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Adult patients (\>18 years old) scheduled for surgery lasting at least one hour.
  • ASA I-III classification.
  • Signed informed consent.
  • Exclusion Criteria:
  • Pre-existing airway pathology (e.g., tracheomalacia, granulomas, stenosis, tumors).
  • Anticipated difficult intubation (Macocha Score \> 3 points).
  • Selective lung ventilation / one-lung ventilation.
  • Current participation in another clinical trial.
  • Elimination Criteria:
  • Accidental extubation.
  • Cardiorespiratory arrest or death.

About Argentinian Intensive Care Society

The Argentinian Intensive Care Society (SACI) is a leading organization dedicated to advancing the field of intensive care medicine in Argentina. Committed to enhancing patient outcomes through research, education, and advocacy, SACI collaborates with healthcare professionals and institutions to promote best practices in critical care. The society plays a pivotal role in conducting clinical trials that evaluate innovative treatment approaches and improve clinical standards, ultimately striving to elevate the quality of care provided to critically ill patients across the nation. With a focus on multidisciplinary collaboration and evidence-based practices, SACI is at the forefront of transforming intensive care practices in Argentina.

Locations

Caba, Buenos Aires, Argentina

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported