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細気管支炎治療における非侵襲的換気と神経調節換気補助(NAVA)の比較

2026年11月10日 更新者:Montefiore Medical Center

従来の非侵襲的換気と神経調節換気補助 (NAVA) の細気管支炎治療のための非侵襲的換気の比較

This project aims to answer whether the use of a Neurally-Adjusted Ventilatory Assistance mode for non-invasive ventilation in pediatric patients with bronchiolitis results in improved comfort and reduced escalations in therapy (including intubation) when compared to using a standard mode of non-invasive ventilation. Neurally-Adjusted Ventilatory Assistance (NAVA) has been shown to result in greater synchrony then the standard mode of non-invasive ventilation. The study team hypothesizes that this improved synchrony can result in important clinical improvements when NAVA is used to treat children with bronchiolitis.

調査の概要

詳細な説明

Bronchiolitis is a common diagnosis in pediatric hospitals and critical care units. Viral infection in younger patients often results in increased work of breathing, hypoxemia, impaired ventilation, and increased secretion burden. In some cases, treatment of severe respiratory failure includes intubation and mechanical ventilation. Current practice for patients with bronchiolitis who require hospital admission is to initially provide non-invasive ventilation to improve the patient's respiratory mechanics. This non-invasive respiratory support can range from simple nasal cannula, to high-flow nasal cannula, to non-invasive positive pressure ventilation.

The high-flow nasal cannula (HFNC) provides warm, humidified, oxygen-enriched air. Therapy commonly is prescribed with a prescribed fraction of inhaled oxygen (FiO2) delivered at 1-2 L/kg/min. This helps to improve oxygenation as the high rate of flow can "wash-out" carbon dioxide in the upper airways and thus reduce the volume of dead space ventilation.

Non-invasive ventilation (NIV) essentially provides a similar method of support as invasive ventilation without the use of endotracheal tube. Prescribed airway support is instead delivered non-invasively through a specialized nasal cannula or for larger children an occlusive facemask of appropriate size. The ventilator provides positive-end expiratory pressure (PEEP) with a prescribed delivery rate of a set inspiratory pressure (positive inspiratory pressure, or pressure control). This ventilator support enables the delivery of a set FiO2, helps maintain open airways to reduce atelectasis and allow for improved oxygenation with better V/Q matching, and improves work of breathing. The ventilator analyzes the flow generated by the patient's inspiratory effort and attempts to provide the prescribed positive inspiratory pressure at the time of the patient's own effort.

One of the major drawbacks of non-invasive ventilation for young pediatric patients with bronchiolitis is the difficulty in achieving synchrony between patient effort and ventilator-delivered positive inspiratory pressure. This is secondary to the large air leak given the non-invasive apparatus and the low inspiratory flows generated by this patient population. Thus, the ventilator and patient are often dyssynchronous which may actually increase work of breathing and agitation while impeding on the ventilatory support provided.

Neurally-Adjusted Ventilatory Assistance (NAVA) attempts to mitigate the harms of ventilator/patient dyssynchrony. This modality utilizes a specialized catheter placed into the esophagus, often via a nasogastric route, which has the capability of monitoring the electrical activity of the patient's diaphragm. This catheter can also be utilized to deliver feeds similarly to a basic nasogastric tube. The NAVA catheter monitors both the activation of the patient's diaphragm (indicating patient respiratory effort) and the strength of this activation in, referred to as the electrical activity of the diaphragm (Edi) and measured in millivolts (µV). Both human and animal studies have positively correlated the peak Edi values with work-of-breathing and demonstrated higher Edi values when respiratory pathology is present . Based on the Edi tracing, the ventilator can then deliver positive inspiratory pressure that is synchronous with both the patient's respiratory effort and proportional to the strength of this effort through a multiplier referred to as the NAVA level on the ventilator. This modality has been shown to improve patient agitation levels, reduce the need for sedating medications, and enhance synchrony in non-invasive ventilation modes.

The current practice model of the investigators entails that patients with bronchiolitis who require more than 1.5 L/kg of HFNC or require non-invasive ventilation, whether via a conventional or NAVA modality, are managed in the Pediatric Intensive Care Unit (PICU). Both modalities for non-invasive ventilation (conventional and NAVA) are used routinely. Patient respiratory status is aggregated into a value known as the Respiratory Severity Score (RSS) which accounts for respiratory rate, dyspnea, retractions, and auscultatory findings adjusted for the age of the patient. The RSS value is a validated assessment tool with good interobserver reliability between Medical Doctors (MDs), Registered Nurses (RNs), and Respiratory Therapists (RTs). It is calculated on a 4-hour basis for all patients with bronchiolitis in the investigator's PICU and helps determine clinical improvement or deterioration and better guide decisions to increase or decrease support.

While multiple physiologic studies demonstrate a reduced work of breathing with invasive NAVA ventilation, the majority of pediatric studies focused on non-invasive NAVA ventilation were designed to determine improvements in patient/ventilator synchronization. The investigators' project aims are two-fold. The study team hypothesizes that Edi levels and RSS scores will positively correlate for patients with bronchiolitis, allowing for another metric to gauge clinical status. The investigators also hypothesizes that the improved synchronization on NAVA-NIV may improve respiratory status as measured by RSS scores and Edi levels, reduce further escalations in respiratory support, shorten the length of non-invasive ventilation required, and reduce intubation rates. This improvement will be more substantial when transitioning from HFNC to NAVA-NIV compared to transitioning to conventional-NIV.

研究の種類

介入

入学 (実際)

20

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • New York
      • The Bronx、New York、アメリカ、10467
        • Children's Hospital at Montefiore

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

1秒~2年 (子)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  • Patients under the age of two years old with a diagnosis of bronchiolitis presenting to the pediatric ICU
  • Patient's provider believes there is equipoise between the use of NAVA or conventional non-invasive ventilation for the patient

Exclusion Criteria:

  • Patients unable to utilize a nasogastric tube
  • Patients with a diagnosis of chronic lung disease, cyanotic heart lesions, or congestive heart failure
  • Patients with hypotonia
  • Patients likely to require imminent intubation: >0.60 Fraction of Inspired Oxygen (FiO2); Carbon Dioxide (CO2) > 60, frequent apneas, clinician determines patient unlikely to tolerate non-invasive modality)
  • Patients with hemodynamic instability, defined as the need for vasoactive medication

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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:ランダム化
  • 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
アクティブコンパレータ:Standard Non-Invasive Mechanical Servo Ventilation Arm

This arm will utilize a standard mode of non-invasive ventilation within protocol parameters.

The active comparator arm will utilize a standard non-invasive mode to provide ventilation support

実験的:Neurally-Adjusted Ventilatory Assistance (NAVA) Non-Invasive Mechanical Servo Ventilation Arm

This arm with utilize a NAVA mode of non-invasive ventilation within protocol parameters.

The experimental arm will utilize a NAVA mode to provide non-invasive ventilation support

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
メジャーの説明
時間枠
Baseline Respiratory Severity Score (RSS)
時間枠:Approximately one hour after Edi catheter placement

RSS is a validated measure of severity in children with bronchiolitis, scored from 0-12 with higher numbers indicating greater severity. If able, baseline scores will be taken before randomization to either treatment arm.

Approximately one hour after Edi catheter placement
Average Respiratory Severity Score (RSS)
時間枠:48 hour average, values collected at ~4 hour intervals.

RSS is a validated measure of severity in children with bronchiolitis, scored from 0-12 with higher numbers indicating greater severity. Average RSS values over a 48-hour period will be reported for each treatment arm.

48 hour average, values collected at ~4 hour intervals.
Baseline Electrical Activity of the Diaphragm (Edi)
時間枠:Approximately one hour after Edi catheter placement

Measure, in microvolts, recorded by the Edi catheter to reflect activity of diaphragmatic activation. Higher values correspond with increased diaphragmatic activation. If able, will be collected prior to randomization to either treatment arm.

Approximately one hour after Edi catheter placement
Average Baseline Electrical Activity of the Diaphragm (Edi)
時間枠:48 hour average, values collected at ~4 hour intervals.

Measure, in microvolts, recorded by the Edi catheter to reflect activity of diaphragmatic activation. Higher values correspond with increased diaphragmatic activation. Average Edi values over a 48-hour period will be reported for each treatment arm.

48 hour average, values collected at ~4 hour intervals.

二次結果の測定

結果測定
メジャーの説明
時間枠
Duration of Non-Invasive Ventilation
時間枠:Time of randomization or start of non-invasive ventilation (whichever occurs last) up to 4 weeks later or time of intubation (whichever occurs first)

The duration, in hours, that a patient requires non-invasive ventilation.

Time of randomization or start of non-invasive ventilation (whichever occurs last) up to 4 weeks later or time of intubation (whichever occurs first)
Number of participants requiring intubation
時間枠:Following start of non-invasive ventilation or randomization (whichever comes last) up to 4 weeks later

If a patient requires intubation due to bronchiolitis, this information will be recorded

Following start of non-invasive ventilation or randomization (whichever comes last) up to 4 weeks later
Frequency of increasing ventilatory support
時間枠:From hours 4-48 of the intervention period

The number of times that a physician increases respiratory support settings on the ventilator (other than FiO2) while remaining within protocol parameters will be documented. The number of events, limited to one event per hour, of increase in respiratory support will be counted during the study period. A greater number of increases in ventilatory support will indicate inadequate response to the treatment arm intervention.

From hours 4-48 of the intervention period
Number of patients requiring dexmedetomidine
時間枠:Through 48 hour study intervention period

The number of patients requiring dexmedetomidine will be tabulated. The use of dexmedetomidine use likely reflects patient agitation and inability to ventilate adequately on non-invasive ventilation. The use of dexmedetomidine may indicate more agitation present within a given treatment arm.

Through 48 hour study intervention period

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Jacqueline Weingarten, MD、Montefiore Medical Center

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2023年12月18日

一次修了 (実際)

2025年5月25日

研究の完了 (実際)

2025年5月25日

試験登録日

最初に提出

2023年9月6日

QC基準を満たした最初の提出物

2023年9月18日

最初の投稿 (実際)

2023年9月26日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月13日

QC基準を満たした最後の更新が送信されました

2026年11月10日

最終確認日

2026年11月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 2022-14633

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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

いいえ

米国FDA規制機器製品の研究

はい

米国で製造され、米国から輸出された製品。

はい

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