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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Wounds and Injuries; Critical Illness; Respiratory Insufficiency
• Intervention / Treatment: Device: Airway Humidification Device

• Study Type: Interventional
• Enrollment (Estimated): 162
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mostafa MA Ali, MSc Candidate; Phone Number: +201091423626; Email: Mostafa1156@aun.edu.eg

Study Locations

• Egypt
  • Asyut Governorate
    • Asyut, Asyut Governorate, Egypt, 71515
      • Trauma Intensive Care Units, Assiut University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Heated Humidifier (HH) Group; Patients in this group will receive active airway humidification using an electric heated humidifier. The device comprises a plastic humidification chamber with a metallic base, containing sterile water, placed on top of an electric heater plate connected to the inspiratory limb of the ventilator circuit.	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.
Experimental: Heat and Moisture Exchanger (HME) Group; Patients in this group will receive passive airway humidification using a disposable heat and moisture exchanger (HME), with or without particle filters, attached directly to the patient's artificial airway to recycle exhaled heat and moisture.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From study enrollment up to 14 days of mechanical ventilation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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.	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.	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.	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.	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.	Through ICU discharge, up to 30 days.

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Chair: Mervat Abdel Aziz, PhD, Faculty of Nursing, Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): July 12, 2026
• Primary Completion (Estimated): April 12, 2027
• Study Completion (Estimated): May 12, 2027

Study Registration Dates

• First Submitted: July 8, 2026
• First Submitted That Met QC Criteria: July 14, 2026
• First Posted (Actual): July 20, 2026

Study Record Updates

• Last Update Posted (Actual): July 20, 2026
• Last Update Submitted That Met QC Criteria: July 14, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Mechanical Ventilation; Heat and Moisture Exchanger; Airway Complications; Heated Humidifier
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Respiratory Tract Diseases; Respiration Disorders; Pathological Conditions, Signs and Symptoms; Respiratory Insufficiency; Critical Illness; Wounds and Injuries
• Other Study ID Numbers: 1120261459

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No