NAVA Use in Preterm Neonates With Respiratory Distress Syndrome
Neurally Adjusted Ventilatory Assist [NAVA] Versus Conventional Ventilation in Preterm Neonates With Respiratory Distress Syndrome
A randomized controlled clinical trial evaluates the efficacy of NAVA in comparison with conventional ventilation (SIMV) in preterm neonates with respiratory distress syndrome.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
Numerous methods for ventilating patients are available in both invasive and noninvasive modes. However, patient-ventilator asynchrony has been a persistent problem .
Neurally adjusted ventilatory assist (NAVA) improves patient-ventilator synchrony in preterm infants, leading to reduced work of breathing, lower peak inspiratory pressures (PIP), and decreased oxygen requirements compared to conventional ventilation . This improved synchrony results in better oxygenation and ventilation, potentially reducing the risk of lung injury and other complications associated with mechanical ventilation in preterm neonates . . NAVA is a mechanical ventilation modality in which the ventilator assists the patient breath in proportion to and in synchrony with the electrical activity of the diaphragm (EAdi) .EAdi is a fast and accurate reflection of phrenic nerve activity arising from central respiratory centers.
During NAVA use, a nasogastric or orogastric tube with electrodes is placed in the patient to detect changes in the diaphragm's electrical activity (Edi) more than 60 times per second . The diaphragm contracts as the phrenic nerves deliver the signal to breathe. The ventilator measures the strength of this activity and provides an appropriately sized breath based on the patient's own effort .
As synchronization in NAVA is independent of pressure or flow trigger and independent of leaks, NAVA has a strong potential to increase invasive ventilation efficiency .
Patient-ventilator asynchrony occurs when the ventilator fails to detect the patient's breath or detects it too late in the breathing cycle, leading to complications that include increased sedation, discomfort, and possibly higher morbidity and mortality .
With NAVA, the patient is actually controlling the trigger, delivery and cycling of every breath. The ventilator becomes completely synchronous with the patient avoiding the undesirable outcomes of patient-ventilator asynchrony. Since the Edi is a reflection of neural respiratory output, ventilator breath delivery is in synchrony with neural control of ventilation .
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研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究連絡先
研究連絡先
- 名前：Rania Ali El-Farrash
- 電話番号：+201222208550
研究場所
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Abbasia
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Cairo、Abbasia、エジプト、11517
- 募集
- Neonatal Intensive Care Units (NICUs), Ain Shams University
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参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Gestational age ≤ 34 weeks.
- Neonates that have RDS according to clinical and radiological findings
- Neonates requiring invasive mechanical ventilation.
Exclusion Criteria:
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1) Preterm neonates that have respiratory distress due to causes other than respiratory distress syndrome including transient tachypnea of new born , congenital pneumonia and sepsis. 2)Central and peripheral conditions that limit the respiratory drive, as well as diaphragmatic anatomical defects in patients with an intact respiratory drive, comprise the contraindications to NAVA
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Examples are the following:
- Central disorder: paralytic drug use, respiratory drive suppression due to heavy sedation or brain injury.
- Peripheral disorder: phrenic nerve injury, paralytic agent administration.
- Structural (anatomical) disorder: esophageal atresia, diaphragmatic hernia. 3) Cardiac patients including aortic coarctation , double outlet right ventricle (DORV), Tetralogy of Fallot and Transposition of the great arteries (TGA). 4) Surgical patients including gastroschisis , omphalocele , tracheoesophageal fistula and congenital diaphragmatic hernia (CDH).
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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：診断
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
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実験的：Experimental: Neurally Adjusted Ventilatory Assist [NAVA] .
After documenting parental consent, preterm neonates with respiratoryd by insufficiency randomly ventilated on NAVA will be assessed by transcranial Doppler ultrasonographic examination and echocardiography. |
ventilator settings will be recorded such as: NAVA level , Edi peak , peep, apnea time |
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アクティブコンパレータ：Active Comparator: Synchronized Intermittent Mandatory Ventilation (SIMV)
After documenting parental consent, preterm neonates with respiratoryd by insufficiency randomly ventilated on SIMV will be assessed by transcranial Doppler ultrasonographic examination and echocardiography. |
ventilator settings will be recorded such as peep , PIP , Fio2 |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Echocardiography
時間枠：baseline and after 24 hours from enrollment in the study
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to assess any structural cardiac anomalies, the patency of ductus arteriosus, right ventricular output (RVO), left ventricular output (LVO), and superior vena cava (SVC) flow, ejection fraction (EF) and pulmonary pressure performed by a specialized echocardiographist. |
baseline and after 24 hours from enrollment in the study
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二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Transcranial ultrasonography Doppler
時間枠：baseline and after 24 hours from enrollment in the study
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applied to the middle cerebral artery to provide an estimate of cerebral blood flow performed by a specialized pediatric radiologist . |
baseline and after 24 hours from enrollment in the study
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Duration of admission
時間枠：up to 8 weeks or till patient discharged or die which comes first
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To document total number of days of admission |
up to 8 weeks or till patient discharged or die which comes first
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Mortality rate
時間枠：up to 8 weeks or till patient death which comes first
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To document incidence of mortality during hospitalization |
up to 8 weeks or till patient death which comes first
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Incidence of feeding intolerance
時間枠：up to 8 weeks or till patient discharged or die which comes first
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Percentage of Patients who developed feeding intolerance |
up to 8 weeks or till patient discharged or die which comes first
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Days to reach full intake
時間枠：up to 8 weeks or till patient discharged or die which comes first
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Number of days needed by each patient to reach full intake |
up to 8 weeks or till patient discharged or die which comes first
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Chest x ray change
時間枠：upon NICU admission and one hour after enrollment in the study .
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Chest x ray grading of RDS performed to patient before and after the assigned mode to compare lung aeration degree |
upon NICU admission and one hour after enrollment in the study .
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
その他の研究ID番号
- NAVA use in preterm neonates
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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