NCT07713238 Humidification Effects on Airway Complications and Clinical Outcomes in Trauma ICU Patients on Mechanical Ventilation
| NCT ID | NCT07713238 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assiut University |
| Condition | Respiratory Insufficiency |
| Study Type | INTERVENTIONAL |
| Enrollment | 162 participants |
| Start Date | 2026-05-13 |
| Primary Completion | 2026-12-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 162 participants in total. It began in 2026-05-13 with a primary completion date of 2026-12-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Mervat Abdel Aziz, PhD
STUDY CHAIR
Faculty of Nursing, Assiut University
Frequently Asked Questions
Who can join the NCT07713238 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Respiratory Insufficiency. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07713238 currently recruiting?
Yes, NCT07713238 is actively recruiting participants. Contact the research team at Mostafa1156@aun.edu.eg for enrollment information.
Where is the NCT07713238 trial being conducted?
This trial is being conducted at Asyut, Egypt.
Who is sponsoring the NCT07713238 clinical trial?
NCT07713238 is sponsored by Assiut University. The principal investigator is Mervat Abdel Aziz, PhD at Faculty of Nursing, Assiut University. The trial plans to enroll 162 participants.