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Starting soon Not applicable

Humidification Effects on Airway Complications and Clinical Outcomes in Trauma ICU Patients on Mechanical Ventilation

NCT07713238 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2026-07-12
Last updated
2026-07-20

Condition(s) studied

Respiratory InsufficiencyWounds and InjuriesCritical Illness

Investigational drug(s) / intervention(s)

Airway Humidification Device

Airway Humidification Device: Application of either active heated humidifiers or passive heat-and-moisture exchangers to provide adequate gas humidification for patients on prolonged mechanical ventilation.

Study summary

This study compares the effects of two primary airway humidification methods-active heated humidifiers (HHs) and passive heat-and-moisture exchangers (HMEs)-on trauma intensive care unit (ICU) patients requiring prolonged mechanical ventilation. Adequate humidification is essential during mechanical ventilation because artificial airways bypass the body's natural ability to warm and moisten inhaled air. While existing guidelines show no overall superiority of one method over the other in general ICU populations, trauma patients present unique challenges, such as thick or bloody secretions, which may lead to airway obstructions and affect the performance of these devices.

The main purpose of this randomized controlled trial is to evaluate how active versus passive humidification impacts airway complications (such as secretion viscosity and tube obstruction) and clinical outcomes (including ventilator-associated pneumonia, duration of mechanical ventilation, length of ICU stay, and mortality rates). A total of 162 adult trauma patients at Assiut University Hospital will be randomly assigned to either the HH group or the HME group to determine if there are significant clinical differences between the two methods in this specific patient population.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria 1. Adult age 18-65 years. 2. Trauma ICU patients receiving invasive mechanical ventilation. 3. Anticipated to require prolonged mechanical ventilation, defined as ≥7 days of invasive ventilatory support Exclusion Criteria: 1. Immunosuppression such as HIV, cancer or AIDS. 2. Blood leukocyte count \<1,000 cells/mm3. 3. Withdrawal of life-sustaining treatment within 5 days. 4. Use of HME in conjunction with an HH. 5. Contraindications of HME including body temperature \< 32°C, copious, thick, or bloody secretions, significant air leak (exhaled VT \>70% of VT inspired) or broncopleural fistula

Primary outcome measure(s)

  • Incidence of Clinically Significant Airway Obstruction — From study enrollment up to 14 days of mechanical ventilation.
    Defined as an unexplained increase in airway resistance (\>15 cmH₂O/L/s) and/or peak airway pressure (\>35 cmH₂O or a sudden increase of 5-10 cmH₂O above baseline) accompanied by evidence of secretion retention, thick secretions with increased suction burden, mucus plugging, partial or complete tube occlusion, difficulty in suction catheter passage, or the need for airway intervention such as bronchoscopy or tube exchange.

Trial sites (1)

FacilityCityRegionStatus
Trauma Intensive Care Units, Assiut University Hospital Asyut Asyut Governorate
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07713238 on ClinicalTrials.gov ↗ ← All trials in Egypt