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.
調査の概要
状態
詳細な説明
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
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Damanhūr、エジプト
- Chest Hospital Damanhour
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
|
アクティブコンパレータ：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Change in arterial carbon dioxide (PaCO2)
時間枠：Baseline and 1 hour after randomization
|
Baseline and 1 hour after randomization
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
入院期間
時間枠：30日まで
|
30日まで
|
|
|
Need for escalation to invasive mechanical ventilation
時間枠：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
時間枠：Baseline and 24 hours
|
Baseline and 24 hours
|
|
|
Change from baseline in arterial carbon dioxide (PaCO₂)
時間枠：Baseline to 24 hours after randomization
|
Baseline to 24 hours after randomization
|
|
|
Change in arterial pH from baseline to 24 hours after randomization
時間枠：Baseline and 24 hours after randomization
|
Baseline and 24 hours after randomization
|
|
|
Change from baseline in respiratory rate
時間枠：Baseline to 24 hours after randomization
|
Baseline to 24 hours after randomization
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター：Eman Mostafa moazen, MD,PhD、Al-Azhar University, Faculty of Medicine
- 主任研究者：Entsar Sayed ahmed, MD,PhD、Faculty of Medicine al Azhar University
- スタディディレクター：Magd Mohamed Galal, MD, PhD、Faculty of Medicine al Azhar University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。