Critical Illness, Respiratory Insufficiency, Wounds and Injuries
Conditions
Keywords
Heated Humidifier, Heat and Moisture Exchanger, Airway Complications, Mechanical Ventilation
Brief 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.
Interventions
DEVICEAirway 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.
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Ventilator-Associated Pneumonia (VAP) | Daily from study enrollment until ICU discharge, up to 30 days. | 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). |
| Duration of Mechanical Ventilation | Daily from study enrollment until successful weaning, up to 30 days. | Total number of days the patient required mechanical ventilation from study enrollment until successful weaning or ICU discharge. |
| ICU Length of Stay | Through ICU discharge, up to 30 days. | Total number of days from ICU admission to official ICU discharge. |
| Total Estimated Hospitalization Cost | At the time of ICU discharge, up to 30 days. | 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. |
| Frequency of Endotracheal Tube Exchange | Daily from study enrollment until ICU discharge, up to 30 days. | The total number of endotracheal tube exchanges required per patient due to partial or complete occlusion or thick secretions. |
| Arterial Oxygenation Status (PaO2/FiO2 Ratio) | Daily from initiation until liberation from mechanical ventilation. | Evaluation of gas exchange efficiency measured via arterial blood gas (ABG) analysis using the PaO2/FiO2 ratio. |
| ICU Mortality Rate | Through ICU discharge, up to 30 days. | Percentage of participants who die from any cause during their stay in the Intensive Care Unit. |
Countries
Egypt
Contacts
CONTACTMostafa MA Ali, MSc Candidate
STUDY_CHAIRMervat Abdel Aziz, PhD
Faculty of Nursing, Assiut University
Outcome results
None listed