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NCT Number: NCT07713238

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

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.

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Key information

Conditions

Respiratory Insufficiency Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Trauma Intensive Care Units, Assiut University Hospital

Asyut, Asyut Governorate, 71515, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.
  • 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

Treatment and study plan

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.

Primary outcomes

  1. Incidence of Clinically Significant Airway Obstruction

    Time frame: 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 outcomes

  1. Incidence of Ventilator-Associated Pneumonia (VAP)

    Time frame: 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).

  2. Duration of Mechanical Ventilation

    Time frame: 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.

  3. ICU Length of Stay

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

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

  4. Total Estimated Hospitalization Cost

    Time frame: 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.

  5. Frequency of Endotracheal Tube Exchange

    Time frame: 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.

  6. Arterial Oxygenation Status (PaO2/FiO2 Ratio)

    Time frame: 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.

  7. ICU Mortality Rate

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

    Percentage of participants who die from any cause during their stay in the Intensive Care Unit.

Study contacts

Contact information is provided by the study sponsor or research team.

Mostafa MA Ali, MSc Candidate

CONTACT

[email protected]

+201091423626

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Effect of Active Versus Passive Humidification on Airway Complications and Clinical Outcomes in Trauma ICU Patients With Prolonged Mechanical Ventilation

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 20, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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