Effect of Continuous Positive Airway Pressure Delivered by Two Different Modalities on Breathing Pattern in Preterm Infants
Effects of Continuous Positive Airway Pressure (CPAP) Delivered by High Flow Nasal Cannula Versus Nasal Continuous Positive Airway Pressure on the Diaphragm Electrical Activity in Very Low Birth Weight Preterm Infants
調査の概要
状態
条件
詳細な説明
Many preterm very low birth weight infants require continuous positive airway pressure(CPAP) for breathing support because of lung immaturity. CPAP can be delivered by the infant flow(TM) device which is well studied. Prolonged use of nasal prongs CPAP has been shown to cause discomfort and, rarely, nasal injury leading to long term disfigurement. On the other hand, High flow nasal cannula (HFNC) ,which is another modality of delivering CPAP, creates less pressure on the nose and less disfiguring effect but previous research showed that the use of HFNC may be less effective than IF-CPAP in providing breathing support in these infants.
We plan to study 10 stable preterm infants born less than 32 weeks' gestation and 1.5 kilograms at birth after being stable for at least 48hours on IF-CPAP. babies will be randomized to start on IF-CPAP or HFNC for 30 minutes. After 45 minutes of adaptation, baby will be switched to the other modality for another 30 minutes. By inserting a specialized feeding tube with sensors into the stomach, we can measure the electrical activity of the diaphragm (EAdi). By analysing EAdi with each modality of delivering CPAP, we want to directly assess how HFNC affects breathing compared to IF-CPAP.
研究の種類
入学 (予想される)
連絡先と場所
研究場所
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Ontario
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Toronto、Ontario、カナダ
- Sunnybrook Health Sciences Centre
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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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Birth weights ≤ 1500g
- Gestational age less than 32 week
- Stable on nasal continuous positive airway pressure (CPAP) of 5-6cmH20 support for at least 48 hours
- Treated with methylxanthines for apnea of prematurity
- In less than 35% oxygen
Exclusion Criteria:
- Congenital and acquired problem of the gastrointestinal tract
- Phrenic nerve injury and/or diaphragm paralysis
- Esophageal perforation/tracheoesophageal fistula
- Congenital/acquired neurological deficit and/or seizures
- Hemodynamic instability
- Congenital heart disease (including symptomatic patent ductus arteriosus)
- Undergoing treatment for sepsis or pneumonia
- Use of muscle relaxants, narcotic analgesics, or gastric motility agents
- Congenital anomalies of respiratory tract (e.g. CCAM)
- Infants requiring more than 35% oxygen
- Infants with facial anomalies
- Infants with pneumothorax and/or pneumomediatinum
- Infants in the immediate postoperative period
- Infants with significant gastric residues and vomiting
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
コホートと介入
グループ/コホート |
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EAdi 1
babies in this group will first receive CPAP through IF-CPAP for 30 minutes.
After another 45 minutes, they will be switched to HFNC for 30 minutes.
EAdi will be recorded for the last 15 minutes of each 30 minutes period.
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EAdi 2
babies in this group will first receive CPAP through HFNC for 30 minutes.
After another 45 minutes, they will be switched to IF-CPAP for 30 minutes.
EAdi will be recorded for the last 15 minutes of each 30 minutes period.
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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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The difference in the tonic EAdi between IF-CPAP and HFNC .
時間枠：During the 4-hour study period.
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Patients will be randomized in two groups, one group will start on IF-CPAP for 30 minutes.
After another 45 minutes, this group will be switched to HFNC for another 30 minutes.
The other group will start on HFNC and then switched to IF-CPAP.
EAdi will be analyzed in the last 15 minutes of each 30 minutes period.
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During the 4-hour study period.
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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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Difference in the number of apnea episodes (breathing pauses) on EAdi recorded with each modality.
時間枠：During the 4-hour study period.
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During the 4-hour study period.
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Difference in episodes of clinically significant apnea with HFNC and IF-CPAP.
時間枠：During the 4-hour study period.
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During the 4-hour study period.
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Indices of respiratory muscle effort (inspiratory and expiratory) will be calculated from Edi waveform.
時間枠：During the 4-hour study period.
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These indices include the phasic Edi to the peak, mean inspiratory Edi, Edi-time product, post inspiratory activity and all neural timings.
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During the 4-hour study period.
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協力者と研究者
捜査官
- 主任研究者：Michael Dunn, MD、Sunnybrook Health Sciences Centre
- 主任研究者：Nehad Nasef, M.B.B.Ch、Sunnybrook Health Sciences Centre
- 主任研究者：Maureen Reilly, RRT、Sunnybrook Health Sciences Centre
- 主任研究者：Patti Schurr, RN(EC)、Sunnybrook Health Sciences Centre
- 主任研究者：Jennifer Beck, Ph.D.、Unity Health Toronto
- スタディディレクター：Eugene Ng, MD、Sunnybrook Health Sciences Centre
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 (見積もり)
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
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