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

14. juli 2026 opdateret af: Mostafa Muhammad Ahmad Ali, Assiut University

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

162

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Enhed: 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.
Eksperimentel: 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.
Enhed: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of Clinically Significant Airway Obstruction
Tidsramme: 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.
From study enrollment up to 14 days of mechanical ventilation.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of Ventilator-Associated Pneumonia (VAP)
Tidsramme: 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).
Daily from study enrollment until ICU discharge, up to 30 days.
Duration of Mechanical Ventilation
Tidsramme: 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.
Daily from study enrollment until successful weaning, up to 30 days.
ICU Length of Stay
Tidsramme: Through ICU discharge, up to 30 days.
Total number of days from ICU admission to official ICU discharge.
Through ICU discharge, up to 30 days.
Total Estimated Hospitalization Cost
Tidsramme: 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.
At the time of ICU discharge, up to 30 days.
Frequency of Endotracheal Tube Exchange
Tidsramme: 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.
Daily from study enrollment until ICU discharge, up to 30 days.
Arterial Oxygenation Status (PaO2/FiO2 Ratio)
Tidsramme: 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.
Daily from initiation until liberation from mechanical ventilation.
ICU Mortality Rate
Tidsramme: Through ICU discharge, up to 30 days.
Percentage of participants who die from any cause during their stay in the Intensive Care Unit.
Through ICU discharge, up to 30 days.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Assiut University

Efterforskere

  • Studiestol: Mervat Abdel Aziz, PhD, Faculty of Nursing, Assiut University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

12. juli 2026

Primær færdiggørelse (Anslået)

12. april 2027

Studieafslutning (Anslået)

12. maj 2027

Datoer for studieregistrering

Først indsendt

8. juli 2026

Først indsendt, der opfyldte QC-kriterier

14. juli 2026

Først opslået (Faktiske)

20. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1120261459

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