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Silent Aspiration Following Extubation in the ICU

NCT07635888 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 274

Last updated 2026-06-09

No results posted yet for this study

Summary

Post-extubation dysphagia is common in critically ill patients and may lead to silent aspiration, which often remains undetected because patients do not exhibit overt clinical signs such as coughing or choking. Current bedside nursing swallow screening may fail to identify silent aspiration in patients recovering from prolonged mechanical ventilation.

The goal of this observational study is to learn about the incidence, risk factors, and clinical outcomes of silent aspiration in critically ill adult patients who require prolonged mechanical ventilation and are extubated in the ICU. The main questions it aims to answer are:

* How often does silent aspiration occur in ICU patients intubated for 5 days or longer after extubation?
* Can silent aspiration be present despite passing the routine bedside nursing swallow screen?
* What clinical factors are associated with silent aspiration?
* Is silent aspiration associated with worse clinical outcomes such as aspiration pneumonia, reintubation, prolonged ICU stay, ventilator-free days, or mortality? Participants who have been mechanically ventilated for 5 days or more will undergo routine bedside swallow screening followed by Fiberoptic Endoscopic Evaluation of Swallowing (FEES), considered the gold-standard diagnostic tool for detecting silent aspiration, within 72 hours after extubation. Researchers will compare bedside nursing swallow screening results with FEES findings to evaluate the diagnostic accuracy of bedside screening in detecting silent aspiration. Clinical data, swallowing assessment findings, and patient outcomes will also be collected and analyzed.

Conditions

  • Silent Aspiration
  • Post-Extubation Dysphagia
  • Deglutition Disorders
  • Critical Illness
  • Mechanical Ventilation Complication

Interventions

DIAGNOSTIC_TEST

Fiberoptic Endoscopic Evaluation of Swallowing (FEES)

FEES will be performed within 72 hours after extubation to assess swallowing function and detect silent aspiration in ICU patients following prolonged mechanical ventilation.

Sponsors & Collaborators

  • Cleveland Clinic Abu Dhabi

    lead OTHER

Principal Investigators

  • Jihad Mallat, MD, PhD · Cleveland Clinic Abu Dhabi

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2028-06-30
Completion
2028-06-30

Countries

  • United Arab Emirates

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07635888 on ClinicalTrials.gov