Respiratory Distress Syndrome
Conditions
Keywords
Respiratory distress syndrome, Preterm infants, Vascular catheter, Surfactant, CPAP, ECALMIST
Brief summary
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.
Detailed description
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.
Interventions
DEVICEECALMIST
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
Sponsors
University of Manitoba
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Minutes to 24 Hours
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Early Ventilation Hours | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Saturation During the Procedure | 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. |
| Failure to Catheterized the Trachea by the Vascular Catheter | 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. |
| Index Before the Procedure | 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. |
| CPAP Pressure After the Procedure | 4 hours | Continuous positive airway pressure (CPAP) is measured in centimeter of water |
| Oxygen Requirement Before the Procedure | 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. |
| Incidence of Bradycardia During Procedure | 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. |
| Index After the Procedure | 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. |
| CPAP Pressure Before the Proceudre | 1 hour | Continuous positive airway pressure (CPAP) pressure is measured in centimeter of water as recorded from CPAP machine (continuous positive airway pressure) |
| Oxygen Saturation Before the Procedure | 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. |
| Oxygen Requirements After the Procedure | 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%. |
| Needs for Intubation During the Procedure | 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) |
| Oxygen Saturation After the Procedure | 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. |
Countries
Canada
Participant flow
Recruitment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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) | 21 |
| Total | 21 |
Baseline characteristics
| Characteristic | Angiocath Surfactant |
|---|---|
| Age, Categorical <=18 years | 21 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age Continuous | 29 Weeks STANDARD_DEVIATION 3 |
| Region of Enrollment Canada | 21 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 21 |
| serious Total, serious adverse events | 3 / 21 |
Outcome results
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
Time frame: 72 hours
Population: 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)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Surfactant Administration Through Vascular Catheter | Incidence of Early Ventilation Hours | 4 Number of participants |
Secondary
CPAP Pressure After the Procedure
Continuous positive airway pressure (CPAP) is measured in centimeter of water
Time frame: 4 hours
Population: The mean of CPAP pressure express as centimeter of water of all participants after completion of ECALMIST
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Surfactant Administration Through Vascular Catheter | CPAP Pressure After the Procedure | 5.8 Centimeter of water | Standard Deviation 0.471 |
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)
Time frame: 1 hour
Population: The mean of CPAP pressure that is measured by centimeter of water of all the participant before ECALMIST
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Surfactant Administration Through Vascular Catheter | CPAP Pressure Before the Proceudre | 7.1 Centimeter of water | Standard Deviation 0.447 |
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.
Time frame: 20 seconds
Population: Number of infatns that failed to pass the angiocath to the trachea after 2 trials, 20 seconds each trial.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Surfactant Administration Through Vascular Catheter | Failure to Catheterized the Trachea by the Vascular Catheter | 1 Number of participants |
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.
Time frame: Range of 10 minutes
Population: 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)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Surfactant Administration Through Vascular Catheter | Incidence of Bradycardia During Procedure | 3 Number of participants |
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.
Time frame: 4 hours
Population: The mean of ECALMIST index of all the participants after ECALMIST
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Surfactant Administration Through Vascular Catheter | Index After the Procedure | 1.27 Score | Standard Deviation 1.8 |
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.
Time frame: 1 hour
Population: The mean of index of all participants before ECALMIST
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Surfactant Administration Through Vascular Catheter | Index Before the Procedure | 2.61 Score | Standard Deviation 0.81 |
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)
Time frame: 10 minutes
Population: The number of preterm infants that needed intubation by ETT (endotracheal intubation) during ECALMIST
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Surfactant Administration Through Vascular Catheter | Needs for Intubation During the Procedure | 3 Number of participants |
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.
Time frame: 1 hour
Population: The mean of oxygen requirement of all the participants before ECALMIST
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Surfactant Administration Through Vascular Catheter | Oxygen Requirement Before the Procedure | 0.308 Proportion of oxygen requirement | Standard Deviation 0.068 |
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%.
Time frame: 4 hours
Population: The mean of oxygen level (proportion) of all participant after ECALMIST
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Surfactant Administration Through Vascular Catheter | Oxygen Requirements After the Procedure | 0.257 Proportion of oxygen saturation | Standard Deviation 0.084 |
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.
Time frame: 4 hours
Population: The mean of oxygen saturation after ECALMIST for all the participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Surfactant Administration Through Vascular Catheter | Oxygen Saturation After the Procedure | 0.94 Proportion of oxygen saturation | Standard Deviation 0.04 |
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.
Time frame: 1 hour
Population: The mean of saturation of all participants before ECALMIST
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Surfactant Administration Through Vascular Catheter | Oxygen Saturation Before the Procedure | 0.87 Proportion of oxygen saturation | Standard Deviation 0.08 |
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.
Time frame: 10 minutes
Population: The mean of oxygen saturation of all participants during ECALMIST(measured by minutes which is variable according participant tolerance of the ECALMIST procedure)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Surfactant Administration Through Vascular Catheter | Saturation During the Procedure | 0.87 Proportion of oxygen saturation | Standard Deviation 0.08 |