Respiratory InsufficiencyNCT07713238
Humidification Effects on Airway Complications and Clinical Outcomes in Trauma ICU Patients on Mechanical Ventilation
A study testing Airway Humidification Device in people with Respiratory Insufficiency and Wounds and Injuries, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Respiratory Insufficiency, Wounds and Injuries, Critical Illness
- What is being tested?
- Airway Humidification Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteEgypt
- Study dates
- 13 May 2026to 12 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Trauma Intensive Care Units, Assiut University Hospital
Asyut, Asyut Governorate, 71515
About this study
Official title: 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.
- Being tested
- Airway Humidification Device
- Keywords
- Heated Humidifier, Heat and Moisture Exchanger, Airway Complications, Mechanical Ventilation
- Medical subject headings
- Respiratory Insufficiency, Wounds and Injuries, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Airway Humidification DeviceDevice
Application of either active heated humidifiers or passive heat-and-moisture exchangers to provide adequate gas humidification for patients on prolonged mechanical ventilation.
| Study group | Role | What they receive |
|---|---|---|
| Heated Humidifier (HH) Group | Experimental | 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. Receives: Device: Airway Humidification Device |
| Heat and Moisture Exchanger (HME) Group | Experimental | 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. Receives: Device: Airway Humidification Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From study enrollment up to 14 days of mechanical ventilation.
Secondary outcomes (7)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through ICU discharge, up to 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start13 May 2026
- Primary completion12 Dec 2026 (estimated)
- Study completion12 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory InsufficiencyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Muhammad Ahmad Ali, Assiut University
- Investigators
- Mervat Abdel Aziz, PhD, Study chair, Faculty of Nursing, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07713238
- Sponsor's protocol ID
- 1120261459
- Status last verified
- Oct 2026
- First submitted
- 8 Jul 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Active Versus Passive Humidification on Airway Complications and Clinical Outcomes in Trauma ICU Patients With Prolonged Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT07713238
- Acronym / sponsor ID
- 1120261459
- Keywords
- Heated Humidifier, Heat and Moisture Exchanger, Airway Complications, Mechanical Ventilation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 13 May 2026 (actual)
- Primary completion
- 12 Dec 2026 (estimated)
- Study completion
- 12 May 2027 (estimated)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heated Humidifier (HH) Group | Experimental | Device: Airway Humidification DevicePatients 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. |
| Heat and Moisture Exchanger (HME) Group | Experimental | Device: Airway Humidification DevicePatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Airway Humidification DeviceApplication of either active heated humidifiers or passive heat-and-moisture exchangers to provide adequate gas humidification for patients on prolonged mechanical ventilation. | Device | Heat and Moisture Exchanger (HME) Group, Heated Humidifier (HH) Group |
Primary outcome
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.
7 secondary outcomes
Incidence of Ventilator-Associated Pneumonia (VAP)
Time frame: Daily from study enrollment until ICU discharge, up to 30 days.
Duration of Mechanical Ventilation
Time frame: Daily from study enrollment until successful weaning, up to 30 days.
ICU Length of Stay
Time frame: Through ICU discharge, up to 30 days.
Total Estimated Hospitalization Cost
Time frame: At the time of ICU discharge, up to 30 days.
Frequency of Endotracheal Tube Exchange
Time frame: Daily from study enrollment until ICU discharge, up to 30 days.
Arterial Oxygenation Status (PaO2/FiO2 Ratio)
Time frame: Daily from initiation until liberation from mechanical ventilation.
ICU Mortality Rate
Time frame: Through ICU discharge, up to 30 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mervat Abdel Aziz, PhD study chair
Faculty of Nursing, Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Airway Humidification Device in people with Respiratory Insufficiency and Wounds and Injuries, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mostafa MA Ali, MSc Candidate (+201091423626, Mostafa1156@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Clinically Significant Airway Obstruction (time frame: From study enrollment up to 14 days of mechanical ventilation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.