Surfactant Via Endotracheal Tube vs. Laryngeal Mask Airway (LMA) in Preterm Neonates With Respiratory Distress Syndrome
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases, Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 1/16/2019 |
| Start Date: | June 2014 |
| End Date: | March 2020 |
| Contact: | Joaquim M Pinheiro, MD, MPH |
| Email: | pinheij@mail.amc.edu |
| Phone: | 518-262-5421 |
Efficacy of Rescue Surfactant Delivery Via Endotracheal Intubation (INSURE Technique) Versus Laryngeal Mask Airway (LMA) for Respiratory Distress Syndrome (RDS) in Preterm Neonates
In this study, newborn babies with respiratory distress syndrome (RDS), receiving oxygen via
nasal continuous airway pressure (CPAP) modalities, and needing surfactant treatment will be
randomized to standard delivery of surfactant via and endotracheal tube airway (inserted
after pre-medication for pain with a short-acting narcotic), or to surfactant delivery via
laryngeal mask airway (LMA). The intent is to remove the airways and return babies to
non-invasive CPAP support, after surfactant is given. The primary outcome measure is the rate
of failure of initial surfactant therapy. Standardized failure criteria are reached: a)
early, if the baby is unable to be placed back on non-invasive CPAP (i.e., needs tracheal
intubation and mechanical ventilation) or, b) late, if the baby requires ventilation,
retreatment with surfactant within 8 hours or more than 2 doses of surfactant.
The objective of this protocol is to reduce the need for endotracheal intubation and
mechanical ventilation in preterm neonates with RDS needing rescue surfactant therapy by
instilling surfactant though an LMA, while achieving comparable efficacy of surfactant
treatment.
The hypothesis is that surfactant treatment through an LMA will decrease the proportion of
babies with RDS who require mechanical ventilation or subsequent intubation, when compared to
standard surfactant treatment following endotracheal intubation with sedation.
nasal continuous airway pressure (CPAP) modalities, and needing surfactant treatment will be
randomized to standard delivery of surfactant via and endotracheal tube airway (inserted
after pre-medication for pain with a short-acting narcotic), or to surfactant delivery via
laryngeal mask airway (LMA). The intent is to remove the airways and return babies to
non-invasive CPAP support, after surfactant is given. The primary outcome measure is the rate
of failure of initial surfactant therapy. Standardized failure criteria are reached: a)
early, if the baby is unable to be placed back on non-invasive CPAP (i.e., needs tracheal
intubation and mechanical ventilation) or, b) late, if the baby requires ventilation,
retreatment with surfactant within 8 hours or more than 2 doses of surfactant.
The objective of this protocol is to reduce the need for endotracheal intubation and
mechanical ventilation in preterm neonates with RDS needing rescue surfactant therapy by
instilling surfactant though an LMA, while achieving comparable efficacy of surfactant
treatment.
The hypothesis is that surfactant treatment through an LMA will decrease the proportion of
babies with RDS who require mechanical ventilation or subsequent intubation, when compared to
standard surfactant treatment following endotracheal intubation with sedation.
Respiratory Distress Syndrome (RDS) due to deficiency of pulmonary surfactant is common in
preterm newborns. Early treatment with surfactant improves oxygenation, reduces the need for
subsequent mechanical ventilation, decreases the incidence of pulmonary air leaks and chronic
lung disease and it also reduces mortality in extremely premature newborns. Optimal treatment
of RDS includes surfactant therapy and avoidance of invasive mechanical ventilation by using
nasal continuous positive airway pressure modes (NCPAP or NIPPV). The current standard method
of surfactant delivery requires tracheal intubation and at least brief positive-pressure
ventilation, as in the INSURE (Intubation-Surfactant-Extubation) approach. Because tracheal
intubation causes pain and vagal-mediated physiologic instability in neonates, premedication
with atropine and a narcotic is recommended. However, narcotic premedication increases
respiratory depression, which may require sustained mechanical ventilation, thus contributing
to the failure of INSURE. In a recent trial at our center, standard pretreatment with
morphine and atropine was associated with failure of INSURE in more than 2/3 of patients.
Consequently, we have recently changed our standard premedication for INSURE to the
combination of atropine and remifentanil (a rapid onset, short-acting narcotic). The
Laryngeal Mask Airway (LMA) is a commercially available, less invasive artificial airway that
does not need to be inserted into the trachea; it is FDA-approved for use in neonates;
preliminary data suggest that it can be used for surfactant administration, which in our
trial was associated with a lower failure rate than the morphine plus INSURE approach.
The main objective of this study protocol is reduce the need for endotracheal intubation and
mechanical ventilation in preterm neonates with mild to moderate RDS needing rescue
surfactant therapy by instilling surfactant though an LMA. A second objective is to compare
the efficacy of surfactant administered via LMA versus endotracheal tube (ETT) in decreasing
the severity of RDS. Additionally, we will further evaluate the safety of surfactant
administration via LMA.
The primary hypothesis is that surfactant therapy delivered via LMA is not inferior to
surfactant therapy delivered via transient intubation (INSURE technique) with short-acting
narcotic premedication for mild to moderate RDS in preterm neonates.
This randomized controlled trial will include babies with mild-to-moderate RDS, less than 48
hours of age, with gestational age 27 0/7 to 36 6/7 weeks, treated with NCPAP (or other NIPPV
modality) ≥ 5 cm H2O and FiO2 between 0.30 and 0.60 for at least 2 hours to maintain oxygen
saturation by pulse oximetry (SpO2) 90-95%.
After informed consent is obtained, babies are randomly assigned (from sealed, opaque,
consecutively numbered envelopes), to "ETT" or "LMA" groups. The "ETT" group is managed
according to our current INSURE approach to surfactant therapy (endotracheal intubation
following premedication with atropine + remifentanil), whereas the "LMA" group will be
pre-medicated with atropine before LMA insertion for surfactant administration.
Both groups will receive Infasurf (3mL/kg) instilled in 2 aliquots via their respective
airway, followed by PPV for at least 5 minutes. The artificial airway will be removed and the
patient returned to NCPAP/NIPPV by 15 minutes, if spontaneous respirations are adequate.
Indications for surfactant re-dosing and mechanical ventilation will be equivalent for both
groups. Babies will continue or initiate assisted ventilation via ETT if any of the following
occurs:
- Persistent apnea;
- Severe retractions;
- Inability to wean FiO2 < 60%
Criteria for re‐dosing with surfactant:
1. Within 8 hours after first dose of surfactant:
• FiO2 20% higher than the baseline FiO2, after excluding other obvious causes of
respiratory insufficiency such as pneumothorax.
If early re‐dosing of surfactant is needed in patients of either group, it will be
administered via ETT (i.e., LMA patients will be intubated, and will receive the dose of
surfactant via ETT)
2. Beyond 8 hours of the first dose of surfactant:
- FiO2 is ≥ 60%, or;
- FiO2 is ≥ 30% associated with worsening clinical signs of RDS.
If late re‐dosing is needed in patients of the LMA group, use of the LMA is permitted for the
second dose. In the ETT group, all doses are given via the ETT.
preterm newborns. Early treatment with surfactant improves oxygenation, reduces the need for
subsequent mechanical ventilation, decreases the incidence of pulmonary air leaks and chronic
lung disease and it also reduces mortality in extremely premature newborns. Optimal treatment
of RDS includes surfactant therapy and avoidance of invasive mechanical ventilation by using
nasal continuous positive airway pressure modes (NCPAP or NIPPV). The current standard method
of surfactant delivery requires tracheal intubation and at least brief positive-pressure
ventilation, as in the INSURE (Intubation-Surfactant-Extubation) approach. Because tracheal
intubation causes pain and vagal-mediated physiologic instability in neonates, premedication
with atropine and a narcotic is recommended. However, narcotic premedication increases
respiratory depression, which may require sustained mechanical ventilation, thus contributing
to the failure of INSURE. In a recent trial at our center, standard pretreatment with
morphine and atropine was associated with failure of INSURE in more than 2/3 of patients.
Consequently, we have recently changed our standard premedication for INSURE to the
combination of atropine and remifentanil (a rapid onset, short-acting narcotic). The
Laryngeal Mask Airway (LMA) is a commercially available, less invasive artificial airway that
does not need to be inserted into the trachea; it is FDA-approved for use in neonates;
preliminary data suggest that it can be used for surfactant administration, which in our
trial was associated with a lower failure rate than the morphine plus INSURE approach.
The main objective of this study protocol is reduce the need for endotracheal intubation and
mechanical ventilation in preterm neonates with mild to moderate RDS needing rescue
surfactant therapy by instilling surfactant though an LMA. A second objective is to compare
the efficacy of surfactant administered via LMA versus endotracheal tube (ETT) in decreasing
the severity of RDS. Additionally, we will further evaluate the safety of surfactant
administration via LMA.
The primary hypothesis is that surfactant therapy delivered via LMA is not inferior to
surfactant therapy delivered via transient intubation (INSURE technique) with short-acting
narcotic premedication for mild to moderate RDS in preterm neonates.
This randomized controlled trial will include babies with mild-to-moderate RDS, less than 48
hours of age, with gestational age 27 0/7 to 36 6/7 weeks, treated with NCPAP (or other NIPPV
modality) ≥ 5 cm H2O and FiO2 between 0.30 and 0.60 for at least 2 hours to maintain oxygen
saturation by pulse oximetry (SpO2) 90-95%.
After informed consent is obtained, babies are randomly assigned (from sealed, opaque,
consecutively numbered envelopes), to "ETT" or "LMA" groups. The "ETT" group is managed
according to our current INSURE approach to surfactant therapy (endotracheal intubation
following premedication with atropine + remifentanil), whereas the "LMA" group will be
pre-medicated with atropine before LMA insertion for surfactant administration.
Both groups will receive Infasurf (3mL/kg) instilled in 2 aliquots via their respective
airway, followed by PPV for at least 5 minutes. The artificial airway will be removed and the
patient returned to NCPAP/NIPPV by 15 minutes, if spontaneous respirations are adequate.
Indications for surfactant re-dosing and mechanical ventilation will be equivalent for both
groups. Babies will continue or initiate assisted ventilation via ETT if any of the following
occurs:
- Persistent apnea;
- Severe retractions;
- Inability to wean FiO2 < 60%
Criteria for re‐dosing with surfactant:
1. Within 8 hours after first dose of surfactant:
• FiO2 20% higher than the baseline FiO2, after excluding other obvious causes of
respiratory insufficiency such as pneumothorax.
If early re‐dosing of surfactant is needed in patients of either group, it will be
administered via ETT (i.e., LMA patients will be intubated, and will receive the dose of
surfactant via ETT)
2. Beyond 8 hours of the first dose of surfactant:
- FiO2 is ≥ 60%, or;
- FiO2 is ≥ 30% associated with worsening clinical signs of RDS.
If late re‐dosing is needed in patients of the LMA group, use of the LMA is permitted for the
second dose. In the ETT group, all doses are given via the ETT.
Inclusion Criteria:
- Mild-to-moderate RDS;
- Postnatal age 2 to 48 hours;
- Gestational age 27 0/7 to 36 6/7 weeks;
- Treated with nasal CPAP modalities ≥ 5 cm H2O and FiO2 between 0.30 and 0.60 for at
least 2 hours to maintain SpO2 90-95%;
- Informed consent
Exclusion Criteria:
- Weight < 800 g;
- Airway anomalies;
- Pulmonary air leaks;
- Craniofacial or cardiothoracic malformations
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