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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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-
Manitoba
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Winnipeg, Manitoba, Kanada
- St. Boniface Hospital
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Winnipeg, Manitoba, Kanada, R3C0L8
- Children hospital of health Sciences Center
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Winnipeg, Manitoba, Kanada, R3C0L8
- Women's Hospital Health Science Center
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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
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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
Inne nazwy:
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
Inne nazwy:
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Incidence of Early Ventilation Hours
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Incidence of Bradycardia During Procedure
Ramy czasowe: 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
|
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Saturation During the Procedure
Ramy czasowe: 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
Ramy czasowe: 20 seconds
|
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
|
|
Index Before the Procedure
Ramy czasowe: 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
Ramy czasowe: 4 hours
|
Continuous positive airway pressure (CPAP) is measured in centimeter of water
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4 hours
|
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Oxygen Requirement Before the Procedure
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 10 minutes
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The needed for interruption or stop of ECALMIST to give PPV (positive pressure ventilation or mechanical ventilation though intubation by ETT (endotracheal intubation)
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10 minutes
|
Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Yahya Al Ethawi, MD, University of Manitoba
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- B2012:016
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