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

NCT07713238 | Not Yet Recruiting

• 1 other identifier: 1120261459
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Insufficiency; Wounds and Injuries; Critical Illness

Keywords

Heated Humidifier; Heat and Moisture Exchanger; Airway Complications; Mechanical Ventilation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Incidence of Ventilator-Associated Pneumonia (VAP)

  Daily from study enrollment until ICU discharge, up to 30 days.

• Duration of Mechanical Ventilation

  Daily from study enrollment until successful weaning, up to 30 days.

• ICU Length of Stay

  Through ICU discharge, up to 30 days.

• Total Estimated Hospitalization Cost

  At the time of ICU discharge, up to 30 days.

• Frequency of Endotracheal Tube Exchange

  Daily from study enrollment until ICU discharge, up to 30 days.

Study Arms (2)

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.

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.

Device: Airway Humidification Device

Interventions

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.

Heat and Moisture Exchanger (HME) Group; Heated Humidifier (HH) Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Trauma Intensive Care Units, Assiut University Hospital

Asyut, Asyut Governorate, 71515, Egypt

Location

MeSH Terms

Conditions

Respiratory Insufficiency; Wounds and Injuries; Critical Illness

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mervat Abdel Aziz, PhD

  Faculty of Nursing, Assiut University

  STUDY CHAIR

Central Study Contacts

Mostafa MA Ali, MSc Candidate

CONTACT

+201091423626; Mostafa1156@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of Critical Care and Emergency Nursing

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 20, 2026
• Study Start: July 12, 2026
• Primary Completion (Estimated): April 12, 2027
• Study Completion (Estimated): May 12, 2027
• Last Updated: July 20, 2026

Record last verified: 2026-07

Locations

EG (1)