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.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Mostafa MA Ali, MSc Candidate
- 전화번호: +201091423626
- 이메일: Mostafa1156@aun.edu.eg
연구 장소
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Asyut Governorate
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Asyut, Asyut Governorate, 이집트, 71515
- Trauma Intensive Care Units, Assiut University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria
- 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
Exclusion Criteria:
- 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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
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Application of either active heated humidifiers or passive heat-and-moisture exchangers to provide adequate gas humidification for patients on prolonged mechanical ventilation.
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실험적: 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.
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Application of either active heated humidifiers or passive heat-and-moisture exchangers to provide adequate gas humidification for patients on prolonged mechanical ventilation.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence of Clinically Significant Airway Obstruction
기간: From study enrollment up to 14 days of mechanical ventilation.
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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.
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From study enrollment up to 14 days of mechanical ventilation.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence of Ventilator-Associated Pneumonia (VAP)
기간: Daily from study enrollment until ICU discharge, up to 30 days.
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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).
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Daily from study enrollment until ICU discharge, up to 30 days.
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Duration of Mechanical Ventilation
기간: Daily from study enrollment until successful weaning, up to 30 days.
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Total number of days the patient required mechanical ventilation from study enrollment until successful weaning or ICU discharge.
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Daily from study enrollment until successful weaning, up to 30 days.
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ICU Length of Stay
기간: Through ICU discharge, up to 30 days.
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Total number of days from ICU admission to official ICU discharge.
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Through ICU discharge, up to 30 days.
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Total Estimated Hospitalization Cost
기간: At the time of ICU discharge, up to 30 days.
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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.
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At the time of ICU discharge, up to 30 days.
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Frequency of Endotracheal Tube Exchange
기간: Daily from study enrollment until ICU discharge, up to 30 days.
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The total number of endotracheal tube exchanges required per patient due to partial or complete occlusion or thick secretions.
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Daily from study enrollment until ICU discharge, up to 30 days.
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Arterial Oxygenation Status (PaO2/FiO2 Ratio)
기간: Daily from initiation until liberation from mechanical ventilation.
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Evaluation of gas exchange efficiency measured via arterial blood gas (ABG) analysis using the PaO2/FiO2 ratio.
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Daily from initiation until liberation from mechanical ventilation.
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ICU Mortality Rate
기간: Through ICU discharge, up to 30 days.
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Percentage of participants who die from any cause during their stay in the Intensive Care Unit.
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Through ICU discharge, up to 30 days.
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공동 작업자 및 조사자
수사관
- 연구 의자: Mervat Abdel Aziz, PhD, Faculty of Nursing, Assiut University
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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기타 연구 ID 번호
- 1120261459
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