High Velocity Nasal Insufflation Versus Non Invasive Ventilation in COPD Patients With Acute Hypercapnic Respiratory Failure (HVNI vs NIV CO)
High-velocity Nasal Insufflation Versus Non-invasive Mechanical Ventilation in COPD Patients With Acute Hypercapnic Respiratory Failure
This study is a randomized clinical trial that compares two methods of non-invasive respiratory support in patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD) complicated by acute hypercapnic respiratory failure.
Eligible adult patients admitted with this condition will be randomly assigned to receive either High-Flow Nasal Insufflation (HVNI) or Non-Invasive Ventilation (NIV).
The main goal of the study is to evaluate changes in blood gas levels, especially carbon dioxide (PaCO2), after one hour of treatment. Secondary outcomes include the need for invasive ventilation, length of hospital stay, changes in breathing rate, and in-hospital outcomes.
The study aims to determine whether HVNI can provide a safe and effective alternative to NIV in this group of patients.
연구 개요
상태
상세 설명
This study is a prospective randomized controlled trial conducted on adult patients diagnosed with acute exacerbation of chronic obstructive pulmonary disease (AECOPD) complicated by acute hypercapnic respiratory failure (type II respiratory failure), admitted to the respiratory intensive care unit or emergency department.
COPD is a leading cause of morbidity and mortality worldwide, and acute exacerbations associated with hypercapnic respiratory failure represent a major cause of hospital admission and intensive care utilization. Non-invasive ventilation (NIV) is the standard of care in such cases; however, its use may be limited by patient intolerance, discomfort, and contraindications.
High-Flow Nasal Insufflation (HVNI) is an emerging non-invasive respiratory support modality that delivers heated, humidified oxygen at high flow rates, generating low levels of positive airway pressure, reducing dead space ventilation, and improving oxygenation and ventilation. It may offer improved patient comfort and tolerance compared to NIV.
In this study, eligible patients will be randomly assigned into two groups: Group I: High-Flow Nasal Insufflation (HVNI) Group II: Non-Invasive Ventilation (NIV) Baseline clinical data, arterial blood gases, and severity scores will be recorded. Patients will be monitored for clinical and laboratory response.
The primary endpoint is the mean difference in PaCO2 to evaluate the short-term effect of HVNI and NIV from baseline to one hour after randomization.
The secondary endpoints include the following outcomes:
Treatment change rates (switch to other ventilatory support modality due to clinical deterioration) Proportion of patients with PaCO2 worsening or reduction less than 10 mmHg from baseline, or no improvement in dyspnea Respiratory rate Changes in arterial blood gases Duration of mechanical ventilation (invasive and non-invasive) Length of hospital stay In-hospital mortality
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
-
Damanhūr, 이집트
- Chest Hospital Damanhour
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
Adults aged ≥18 years Diagnosis of acute exacerbation of COPD (AECOPD) Acute hypercapnic respiratory failure (PaCO2 > 45 mmHg with acidosis or indication for ventilatory support) Indication for non-invasive ventilatory support Hemodynamically stable patients Ability to provide informed consent or legal representative consent
Exclusion Criteria:
Age <18 years Immediate need for invasive mechanical ventilation (e.g., apnea, respiratory arrest, severe respiratory distress) Severe hypoxemia (PaO2 < 55 mmHg despite oxygen therapy) Severe acidosis (pH < 7.25) with hypercapnia Neuromuscular disease Unstable hemodynamics (SBP < 90 mmHg or MAP < 65 mmHg despite resuscitation) Hypercapnic respiratory failure due to non-COPD causes Contraindications to HVNI or NIV (facial trauma, obstruction, severe agitation, etc.) Pregnancy BMI > 30 kg/m²
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: HVNI group
Patients in this arm receive High-Velocity Nasal Insufflation (HVNI) as the primary non-invasive respiratory support modality for acute hypercapnic respiratory failure.
HVNI delivers heated and humidified oxygen at high flow rates to improve oxygenation, reduce work of breathing, and enhance patient comfort.
|
High-velocity nasal insufflation delivering heated and humidified oxygen at high flow rates through nasal cannula.
It provides low level positive airway pressure, washout of anatomical dead space, reduction of work of breathing, and improvement in oxygenation and ventilation in patients with acute hypercapnic respiratory failure.
|
|
활성 비교기: NIV group
Patients in this arm receive Non-Invasive Ventilation (NIV) as the standard non-invasive ventilatory support for acute hypercapnic respiratory failure.
NIV provides positive pressure ventilation via mask to improve alveolar ventilation, reduce PaCO2, and correct respiratory acidosis.
|
Non-invasive ventilation delivered via face mask providing positive pressure support to improve alveolar ventilation, decrease PaCO2, correct respiratory acidosis, and reduce work of breathing in patients with acute hypercapnic respiratory failure.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Change in arterial carbon dioxide (PaCO2)
기간: Baseline and 1 hour after randomization
|
Baseline and 1 hour after randomization
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
입원 기간
기간: 최대 30일
|
최대 30일
|
|
|
Need for escalation to invasive mechanical ventilation
기간: Up to 4 days after randomization
|
Proportion of patients requiring invasive mechanical ventilation
|
Up to 4 days after randomization
|
|
Change in arterial pH from baseline to 24 hours after randomization
기간: Baseline and 24 hours
|
Baseline and 24 hours
|
|
|
Change from baseline in arterial carbon dioxide (PaCO₂)
기간: Baseline to 24 hours after randomization
|
Baseline to 24 hours after randomization
|
|
|
Change in arterial pH from baseline to 24 hours after randomization
기간: Baseline and 24 hours after randomization
|
Baseline and 24 hours after randomization
|
|
|
Change from baseline in respiratory rate
기간: Baseline to 24 hours after randomization
|
Baseline to 24 hours after randomization
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Eman Mostafa moazen, MD,PhD, Al-Azhar University, Faculty of Medicine
- 수석 연구원: Entsar Sayed ahmed, MD,PhD, Faculty of Medicine al Azhar University
- 연구 책임자: Magd Mohamed Galal, MD, PhD, Faculty of Medicine al Azhar University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- COPD-HVNI-NIV-2026
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .