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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
162
Application of either active heated humidifiers or passive heat-and-moisture exchangers to provide adequate gas humidification for patients on prolonged mechanical ventilation.
Trauma Intensive Care Units, Assiut University Hospital
Asyut, Asyut Governorate, Egypt
Incidence of Clinically Significant Airway Obstruction
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.
Time frame: From study enrollment up to 14 days of mechanical ventilation.
Incidence of Ventilator-Associated Pneumonia (VAP)
Percentage of patients diagnosed with VAP based on a Clinical Pulmonary Infection Score (CPIS) greater than or equal to 6 and criteria for ventilator-associated events (VAE).
Time frame: Daily from study enrollment until ICU discharge, up to 30 days.
Duration of Mechanical Ventilation
Total number of days the patient required mechanical ventilation from study enrollment until successful weaning or ICU discharge.
Time frame: Daily from study enrollment until successful weaning, up to 30 days.
ICU Length of Stay
Total number of days from ICU admission to official ICU discharge.
Time frame: Through ICU discharge, up to 30 days.
Total Estimated Hospitalization Cost
Total direct medical cost calculated in Egyptian Pounds (EGP) per patient. This includes the cost of respiratory therapy consumables (such as the number of humidifiers and suction catheters used) combined with ICU daily bed rates to compare the overall economic burden between active and passive humidification.
Time frame: At the time of ICU discharge, up to 30 days.
Frequency of Endotracheal Tube Exchange
The total number of endotracheal tube exchanges required per patient due to partial or complete occlusion or thick secretions.
Time frame: Daily from study enrollment until ICU discharge, up to 30 days.
Arterial Oxygenation Status (PaO2/FiO2 Ratio)
Evaluation of gas exchange efficiency measured via arterial blood gas (ABG) analysis using the PaO2/FiO2 ratio.
Time frame: Daily from initiation until liberation from mechanical ventilation.
ICU Mortality Rate
Percentage of participants who die from any cause during their stay in the Intensive Care Unit.
Time frame: Through ICU discharge, up to 30 days.
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