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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAssiut University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Adult age 18-65 years.

Trauma ICU patients receiving invasive mechanical ventilation.

Anticipated to require prolonged mechanical ventilation, defined as ≥7 days of invasive ventilatory support

Disqualifiers

Immunosuppression such as HIV, cancer or AIDS.

Blood leukocyte count <1,000 cells/mm3.

Withdrawal of life-sustaining treatment within 5 days.

Use of HME in conjunction with an HH.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Airway Humidification Device

    Device

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

Treatment groups

162 Participants
are divided into 2 treatment groups
Group A: Heated Humidifier (HH) GroupExperimental treatment 1 intervention
Group B: Heat and Moisture Exchanger (HME) GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Secondary outcomes

1

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.
2

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.
3

ICU Length of Stay

Total number of days from ICU admission to official ICU discharge.

Time frame
Through ICU discharge, up to 30 days.
4

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.

Other outcomes

Sponsors and contacts

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