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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ECALMIST | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ECALMIST | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Early Ventilation 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Bradycardia During Procedure | 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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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:
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| Name | Affiliation | Role |
|---|---|---|
| Yahya Al Ethawi, MD | University of Manitoba | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children hospital of health Sciences Center | Winnipeg | Manitoba | R3C0L8 | Canada | ||
| Women's Hospital Health Science Center |
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| Label | URL |
|---|---|
| If parents, colleagues have any questions, comments or suggestions; you can contact me on Facebook with this link | View source |
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The recruitment period was of 2 months duration form July 5th, 2012 to September 5th, 2012 in 3 hospitals (St Boniface NICU, Children hospital's NICU and Women's hospital delivery room at HSC).
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| ID | Title | Description |
|---|---|---|
| FG000 | Surfactant Through Vascular Catheter | Preterm infants born between 24 to 34 weeks postmenstrual gestation were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)during 1st 24 hours of life |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Angiocath Surfactant | Preterm infants born at 24 to 34 weeks of postmenstrual gestational age were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Incidence of Bradycardia During Procedure | 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. | The mean of heart beat per minute of all participants during ECALMIST(measured by minutes which is variable according participant tolerance of the ECALMIST procedure) | Posted | Number | Number of participants | Range of 10 minutes |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Angiocath Surfactant | Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Brady cardia | Cardiac disorders | Systematic Assessment | Severe brady occurs in 1/21 (14.28%) |
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This is non randomized interventional feasibility trial, small sample size and in one center
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Yahya Al Ethawi | University of Manitoba | 0012049634721 | yalethawi@hsc.mb.ca |
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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| ECALMIST | Device | 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 |
|
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| Saturation During the Procedure |
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 | 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 | 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 | Continuous positive airway pressure (CPAP) is measured in centimeter of water | 4 hours |
| Oxygen Requirement Before the Procedure | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
| Winnipeg |
| Manitoba |
| R3C0L8 |
| Canada |
| St. Boniface Hospital | Winnipeg | Manitoba | Canada |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | Weeks |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Saturation During the Procedure | 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. | The mean of oxygen saturation of all participants during ECALMIST(measured by minutes which is variable according participant tolerance of the ECALMIST procedure) | Posted | Mean | Standard Deviation | Proportion of oxygen saturation | 10 minutes |
|
|
|
| Secondary | Failure to Catheterized the Trachea by the Vascular Catheter | Failure define as inability to pass the vascular catheter to the trachea after 2 trials within 20 seconds time frame for each trial. | Number of infatns that failed to pass the angiocath to the trachea after 2 trials, 20 seconds each trial. | Posted | Number | Number of participants | 20 seconds |
|
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| Primary | Incidence of Early Ventilation 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 | The number of preterm infants that need intubation by ETT within 72 hours of life(early ventilation). This is includes all infants intubated whether during or after the ECALMIST procedure in the 1st 3 days of life (after delivery) | Posted | Number | Number of participants | 72 hours |
|
|
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| Secondary | Index Before the Procedure | 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. | The mean of index of all participants before ECALMIST | Posted | Mean | Standard Deviation | Score | 1 hour |
|
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| Secondary | CPAP Pressure After the Procedure | Continuous positive airway pressure (CPAP) is measured in centimeter of water | The mean of CPAP pressure express as centimeter of water of all participants after completion of ECALMIST | Posted | Mean | Standard Deviation | Centimeter of water | 4 hours |
|
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| Secondary | Oxygen Requirement Before the Procedure | 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. | The mean of oxygen requirement of all the participants before ECALMIST | Posted | Mean | Standard Deviation | Proportion of oxygen requirement | 1 hour |
|
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| Secondary | Oxygen Saturation After the Procedure | 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. | The mean of oxygen saturation after ECALMIST for all the participants | Posted | Mean | Standard Deviation | Proportion of oxygen saturation | 4 hours |
|
|
|
| Secondary | Index After the Procedure | 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. | The mean of ECALMIST index of all the participants after ECALMIST | Posted | Mean | Standard Deviation | Score | 4 hours |
|
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| Secondary | CPAP Pressure Before the Proceudre | Continuous positive airway pressure (CPAP) pressure is measured in centimeter of water as recorded from CPAP machine (continuous positive airway pressure) | The mean of CPAP pressure that is measured by centimeter of water of all the participant before ECALMIST | Posted | Mean | Standard Deviation | Centimeter of water | 1 hour |
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| Secondary | Oxygen Saturation Before the Procedure | 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. | The mean of saturation of all participants before ECALMIST | Posted | Mean | Standard Deviation | Proportion of oxygen saturation | 1 hour |
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| Secondary | Oxygen Requirements After the Procedure | 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%. | The mean of oxygen level (proportion) of all participant after ECALMIST | Posted | Mean | Standard Deviation | Proportion of oxygen saturation | 4 hours |
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| Secondary | Needs for Intubation During the Procedure | The needed for interruption or stop of ECALMIST to give PPV (positive pressure ventilation or mechanical ventilation though intubation by ETT (endotracheal intubation) | The number of preterm infants that needed intubation by ETT (endotracheal intubation) during ECALMIST | Posted | Number | Number of participants | 10 minutes |
|
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| 3 |
| 21 |
| 0 |
| 21 |
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| de-saturation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Desaturation bellow 85% for 10 seconds occurs in 3/21 (14.28) |
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