Patient Comfort During High Flow Nasal Cannula Versus Nasal Continuous Airway Pressure (CPAP)
Patient Comfort During High Flow Nasal Cannula (HFNC)Versus Nasal Continuous Airway Pressure (CPAP): a Cross Over Randomised Trial
Preterm children are at increased risk for developing lung disease due to immature lungs. Non-invasive ventilation (NIV) support is increasingly used as treatment. Nasal continuous positive airway pressure (nCPAP) is the most common NIV-mode. Recently, high flow nasal cannulas (HFNC) have become an alternative NIV-mode. Both nCPAP and HFNC provide increased pressure in the airways aiming to keep the lungs open. With nCPAP it is common to use short binasal prongs that fill the nostrils completely and are pressed tightly over the nose. With HFNC oxygen/air is administered via two small, thin cannulas located just inside the nostrils, but the nostrils are not blocked.
The aim of this study is to compare patient comfort in premature infants treated with nCPAP and HFNC. The investigators hypothesis is that HFNC increases patient comfort.
The study is a randomized cross over study (2 x 24 hours). Children eligible for inclusion should be born before 34 weeks of gestation and have moderate respiratory distress, thus be "in need" of nCPAP. During the study period (48 hours) the investigators will consider how the child tolerates treatment with nCPAP versus HFNC. Primary outcome is patient comfort assessed with the EDIN-score (Neonatal pain and comfort score). Secondary outcomes are stress hormone response (cortisol in saliva), surrounding noise and parental satisfaction. The child's breathing pattern will be carefully monitored. The study involves no extra painful investigations.
The investigators plan to recruit 20 patients.
調査の概要
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
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Tromsø、ノルウェー、N-9038
- University Hospital of North Norway
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参加基準
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:
Preterm infants admitted to the NICU at University Hospital of North Norway, Tromsoe, Norway (single center study)
- Gestational age (GA) < 34 weeks
- Corrected age < 34 weeks
- Receiving nasal CPAP for respiratory distress
- Respiratory "stable": FiO2 < 30%, pCO2 < 8,5 kPa and pH > 7.25.
- GA < 29 weeks: Respiratory "stable" over last 72 h.
- GA 29-33 weeks: Respiratory "stable" over last 24 h.
Exclusion Criteria:
- Congenital anomalies
- Ongoing treatment for hypoglycemia or infection
- Other intercurrent disease requiring frequent blood sampling
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：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：HFNC
High flow nasal cannula
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In the cross over study 2 types of respiratory support are compared; HFNC versus nCPAP
他の名前：
In the cross over study 2 types of respiratory support are compared; HFNC versus nCPAP
他の名前：
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アクティブコンパレータ：nCPAP
Nasal CPAP
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In the cross over study 2 types of respiratory support are compared; HFNC versus nCPAP
他の名前：
In the cross over study 2 types of respiratory support are compared; HFNC versus nCPAP
他の名前：
|
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 |
|---|---|---|
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Patient comfort (EDIN score)
時間枠：48 h (CPAP 24 h and HFNC 24 h); cumulative EDIN score for each 24 epoch is calculated and a change between the two interventions are assessed
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EDIN score (neonatal pain and comfort score) is a validated scoring system to assess pain and comfort in term and preterm infants.
The cumulative EDIN score, based on three evaluations/24 h, is recorded for each 24 h epoch with HFNC or CPAP, respectively.
The change in EDIN score between the two 24 h epochs are assessed.
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48 h (CPAP 24 h and HFNC 24 h); cumulative EDIN score for each 24 epoch is calculated and a change between the two interventions are assessed
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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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Noise
時間枠：Measured at 10 AM and 10 PM over 48 h (4 measurements)
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Surrounding noise (dB)is measured twice daily during the 2 x 24 (48) h study period; twice during CPAP and twice during HFNC.
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Measured at 10 AM and 10 PM over 48 h (4 measurements)
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Parental satisfaction
時間枠：Three questions answered after 24 h and 48 h
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3 questions related to parental satisfaction are asked by the end of each 24 h epoch with either CPAP or HFNC.
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Three questions answered after 24 h and 48 h
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Stress hormone response (salivary cortisol)
時間枠：Measured at 10 AM and 10 PM over 48 h (4 measurements)
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Salivary cortisol is used as a marker of stress hormone response.
Salivary cortisol is collected twice (10 AM and 10 PM) for every 24 h epoch; a total of 4 measurements.
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Measured at 10 AM and 10 PM over 48 h (4 measurements)
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協力者と研究者
捜査官
- 主任研究者：Claus Klingenberg, MD, PhD、University Hospital of North Norway, Tromsø, Norway
出版物と役立つリンク
一般刊行物
- Wilkinson D, Andersen C, O'Donnell CP, De Paoli AG. High flow nasal cannula for respiratory support in preterm infants. Cochrane Database Syst Rev. 2011 May 11;(5):CD006405. doi: 10.1002/14651858.CD006405.pub2.
- Klingenberg C, Pettersen M, Hansen EA, Gustavsen LJ, Dahl IA, Leknessund A, Kaaresen PI, Nordhov M. Patient comfort during treatment with heated humidified high flow nasal cannulae versus nasal continuous positive airway pressure: a randomised cross-over trial. Arch Dis Child Fetal Neonatal Ed. 2014 Mar;99(2):F134-7. doi: 10.1136/archdischild-2013-304525. Epub 2013 Nov 13.
研究記録日
主要日程の研究
研究開始
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 (見積もり)
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。
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