Early CPAP And Large Volume Minimally Invasive Surfactant (ECALMIST) in Preterm Infants With RDS (ECALMIST)
Feasibility of Using Early CPAP (Continuous Positive Airway Pressure) And Large Volume Minimal Invasive Surfactant Therapy (ECALMIST) in Preterm Infants With Respiratory Distress Syndrome (RDS)
Modification of Minimally Invasive Surfactant Therapy (MIST) to a new technique called ECALMIST (Early CPAP And Large volume Minimal Invasive Surfactant). This modification is needed to adapt the use of large volume surfactant of 4-5 ml/kg.
The ECALMIST will be used to deliver the large volume Surfactant that been used in Canada called BLES (about 5 ml for each 100 mg) to the preterm infants bellow 35 weeks gestation suffer from respiratory distress syndrome (RDS) in 1st 24 hours of life while maintained on CPAP.
調査の概要
詳細な説明
The 5 ml/Kg surfactant is warm to room temperature. Using standard laryngoscope without premedication while the infant is maintained on continuous positive airway pressure (CPAP. The the laryngoscope should be removed after stabilizing the vascular catheter between 2 fingers at the level of lips (weight +6 cm). The surfactant will be administer by boluses of 0.25 -0.5 ml at a time over 20-30 seconds and 10 seconds apart while maintain the vital signs.
The procedure should be stopped if the vital signs deteriorate, CPAP pressure and oxygen requirement might need to adjusted to restore baseline vital signs. If the vital signs remained unstable the catheter should be removed and the infant managed according by positive pressure ventilation (PPV) or intubation by endotracheal tube (ETT).
At the end of the procedure the catheter should be flushed with 0.5 ml of air then catheter should be removed.
FiO2 (fraction of inspired oxygen), oxygen saturation and CPAP pressure will be recorded before during and after the procedure.
Complication like bradycardia (Hear rate below 100 beat per minute) or Apnea (pause of respiration for more than 20 second or less than 20 seconds but associated with bradycardia) All other neonatal outcome will be recorded (IVH [Intra-ventricular Hemorrhage], ROP [Retinopathy of prematurity], duration of ventilation, duration of hospital stay, infection, duration of oxygen requirement and others.
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
-
-
Manitoba
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Winnipeg、Manitoba、カナダ
- St. Boniface Hospital
-
Winnipeg、Manitoba、カナダ、R3C0L8
- Children hospital of health Sciences Center
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Winnipeg、Manitoba、カナダ、R3C0L8
- Women's Hospital Health Science Center
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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 less than 35 weeks gestation in 1st day of life with RDS and spontaneously breathing on CPAP and need surfactant administration.
Exclusion Criteria:
- Infants needs of mechanical ventilation
- Congenital anomaly
- Respiratory distress due to non RDS related causes.
- no parental consent
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：単一グループの割り当て
- 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：ECALMIST
Large volume 5ml/kg surfactant administered by vascular catheter while maintaining CPAP or ECALMIST; Early CPAP (continuous positive airway pressure) And Large volume Minimal Invasive Surfactant Therapy
|
Labelled catheter at level of the lips (6 cm plus weight) will inserted through the vocal cords under direct vision using a standard laryngoscope without premedication while maintaining CPAP. 5 ml/kg surfactant syringe will be connected to the catheter hub and 0.25-0.5 ml was administered; then the syringe will be disconnected from the catheter to observe the surfactant moving up and down or coming back as indication of accurate intubation of the trachea.
The surfactant the slowly administer by boluses of 0.25-0.5 ml over 20-30 seconds with 10 seconds apart.
At the end of the procedure, the operator flushed the catheter with 0.5 ml of air before removing the catheter while maintaining CPAP
他の名前：
Vascular catheter of 1.6 French size of 133 mm length 16 gauge used to deliver the BLES; a large volume surfactant while maintain CPAP
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 |
|---|---|---|
|
Incidence of Early Ventilation Hours
時間枠：72 hours
|
The need for mechanical ventilation due to various reasons like sepsis, Apnea (pause of respiration for more than 20 seconds) or Respiratory dysfunction evidenced by abnormal blood gas or desaturation or increase work of breathing
|
72 hours
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of Bradycardia During Procedure
時間枠：Range of 10 minutes
|
Bradycardia is persistent heart rate below 100 beat per minute for more than 20 seconds during the procedure as seen by the monitor or Heart rate below 60 beat per minute for any time if chest compression is needed or if associated with desaturation or apnea.
|
Range of 10 minutes
|
|
Saturation During the Procedure
時間枠：10 minutes
|
Level of oxygen which is measured by oxygen pulse Oximetry.
It is express as proportion out of one which is equal to percentage of 100.
The number can be anywhere between 0.21 to 1 which is equal to percentage of 21 to 100.
|
10 minutes
|
|
Failure to Catheterized the Trachea by the Vascular Catheter
時間枠：20 seconds
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Failure define as inability to pass the vascular catheter to the trachea after 2 trials within 20 seconds time frame for each trial.
|
20 seconds
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Index Before the Procedure
時間枠：1 hour
|
The index is an arbitrary number calculated by equation that is author defined which is(FiO2 * CPAP/ Sat)*100. FiO2: Fraction of inspired oxygen CPAP: continuous positive airway pressure Sat: saturation The equation is similar to the Oxygen index (OI) equation with replacement of Mean airway pressure (MAP) by continuous positive airway pressure (CPAP. It comprehensive view about the 3 parameters (FiO2, CPAP and Sat) during the procedure. |
1 hour
|
|
CPAP Pressure After the Procedure
時間枠：4 hours
|
Continuous positive airway pressure (CPAP) is measured in centimeter of water
|
4 hours
|
|
Oxygen Requirement Before the Procedure
時間枠：1 hour
|
Oxygen requirement or FiO2 (Fraction of inspired oxygen) is expressed as proportion out of one (decimal) or percentage of 100.
The number can be any where between 0.21 to 1 which is equal to percentage of 21 to 100.
|
1 hour
|
|
Oxygen Saturation After the Procedure
時間枠：4 hours
|
Oxygen saturation is measured by pulse oximetry.
It is express as proportion out of 1 (decimal) that is equal to percentage of 100.
The number can be any where between 0.21 to 1 which is equal to percentage of 21 to 100.
|
4 hours
|
|
Index After the Procedure
時間枠：4 hours
|
The index is an arbitrary number calculated by equation that is author defined which is(FiO2 * CPAP/ Sat)*100. FiO2: Fraction of inspired oxygen CPAP: continuous positive airway pressure Sat: saturation The equation is similar to the Oxygen index (OI) equation with replacement of Mean airway pressure (MAP) by continuous positive airway pressure (CPAP. It comprehensive view about the 3 parameters (FiO2, CPAP and Sat) during the procedure. |
4 hours
|
|
CPAP Pressure Before the Proceudre
時間枠：1 hour
|
Continuous positive airway pressure (CPAP) pressure is measured in centimeter of water as recorded from CPAP machine (continuous positive airway pressure)
|
1 hour
|
|
Oxygen Saturation Before the Procedure
時間枠：1 hour
|
Oxygen saturation is measured by pulse oximetry and express as proportion out of one which equal to percentage of 100.
The number can be any where between 0.21 to 1 which is equal to percentage of 21 to 100.
|
1 hour
|
|
Oxygen Requirements After the Procedure
時間枠：4 hours
|
Oxygen requirement is expressed as proportion out of one (decimal) which is equal to percentage of 100.
The measurment can be any where between 0.21 to 1 and this equal to percentage of 21-100%.
|
4 hours
|
|
Needs for Intubation During the Procedure
時間枠：10 minutes
|
The needed for interruption or stop of ECALMIST to give PPV (positive pressure ventilation or mechanical ventilation though intubation by ETT (endotracheal intubation)
|
10 minutes
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Yahya Al Ethawi, MD、University of Manitoba
出版物と役立つリンク
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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