Track topics on Twitter Track topics that are important to you
In this study, newborn babies with respiratory distress syndrome (RDS), receiving oxygen via nasal CPAP, and needing surfactant treatment will be randomized to standard delivery of surfactant via and endotracheal tube airway(inserted after pre-medication for pain), or to surfactant delivery via laryngeal mask airway (LMA). The intent is to remove the airways and return babies to nasal CPAP, 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 CPAP (needs mechanical ventilation) or, b) late, if the baby requires 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 with standard surfactant treatment following sedation and endotracheal intubation.
Respiratory Distress Syndrome (RDS) due to deficiency of lung 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 (NCPAP). The current standard method of surfactant delivery requires tracheal intubation and at least brief positive-pressure ventilation. Tracheal intubation causes pain and leads to vagal-mediated physiologic instability in neonates; therefore, premedication with morphine and atropine is routinely practiced in our setting. However, premedication with morphine often increases respiratory depression, requiring sustained mechanical ventilation. 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, and preliminary data suggest that it can be used for surfactant administration.
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 evaluate the safety of surfactant administration via LMA.
The primary hypothesis is that surfactant treatment via the LMA approach will decrease the proportion of babies with RDS who require mechanical ventilation or subsequent intubation, when compared with standard surfactant as administered to the ETT group.
This randomized controlled trial will include babies with mild-to-moderate RDS, between 4 to 48 hours of age, with gestational age 29 0/7 to 36 6/7 weeks, treated with NCPAP ≥ 5 cm H2O and FiO2 between 0.30 and 0.60 for at least 2 hours to maintain SpO2 88-95%, and informed consent. Exclusion criteria are weight < 1000 g, airway anomalies, pulmonary air leaks, and craniofacial and cardiothoracic malformations.
After informed consent is obtained, babies are randomly assigned (from sealed, opaque, consecutively numbered envelopes), to the "ETT" or "LMA". The "ETT" group is managed according to our current practice of surfactant therapy (endotracheal intubation following premedication with atropine + morphine), 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 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 (early re‐dosing):
- 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, the dose 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 (late re‐dosing):
- FiO2 is ≥ 60%, or;
- FiO2is ≥ 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.
Primary Outcome Measures:
Rate of failure of early surfactant rescue therapy in the 2 groups, using the following criteria to differentiate early from late failure:
- Criteria for early failure (within 1 hour):
1. The need of mechanical ventilation within 1 hour of surfactant therapy.
2. Use of Narcan to avoid mechanical ventilation after surfactant therapy.
- Criteria for late failure (beyond 1 hour):
1. Sustained FiO2 > 0.60 to maintain target SpO2
2. Second dose of surfactant within 8 hours after the first dose.
3. More than 2 doses of surfactant.
Babies will have FiO2 adjusted to maintain SpO2 88-95%, per current practice. Other aspects of weaning ventilatory support will be managed by clinicians' preference.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Respiratory Distress Syndrome, Newborn
Endotracheal tube insertion, Laryngeal mask airway insertion
Albany Medical Center
Albany Medical College
Published on BioPortfolio: 2014-08-27T03:16:53-0400
The i-gel is a new supra glottic airway device with a non inflatable cuff and an oesophageal vent. The aim of this study is to compare this device to the LMA ProSeal. The study is approved...
A prospective study designed to access changes in the intracuff pressure of a laryngeal mask airway (LMA) or cuffed endotracheal tube (cETT) during placement of an esophagogastroduodenosco...
The aim of the current study is to compare the use of laryngeal mask airway (LMA) and endotracheal tube (ETT) in pediatric adenotonsillectomy. The primary objective is to assess the incid...
The ProSeal laryngeal mask airway (PLMA) is a new laryngeal mask device with a modified cuff to improve the seal and a drain tube to prevent aspiration and gastric insufflation. The manufa...
The aim of this study is to evaluate the success rate, insertion time and complication depending on the use of neuromuscular blocking agent when inserting the laryngeal mask airway (LMA).
This study will determine the safety of laryngeal mask airway (LMA) compared with endotracheal tube (ETT) in patients undergoing general anesthesia for dacryocystorhinostomy (DCR) surgery.
Airway management is a critical skill that may be essential in the battlefield. The aim of this study was to determine if combat life savers and medics with no or limited clinical experience could pro...
Objective This study was performed to observe the occurrence of corrected QT (QTc) interval prolongation during anesthetic induction for laryngeal mask airway insertion and the effects of cisatracuriu...
Studies using videotape recordings and respiratory function monitoring have shown that both face mask (FM) application and endotracheal tube (ETT) placement represent a challenge for resuscitators. He...
A 2-month-old girl with abnormal facial features and malnutrition presented for placement of a gastrostomy tube. The surgery was performed under general anesthesia using a laryngeal mask airway (LMA);...
A type of oropharyngeal airway that provides an alternative to endotracheal intubation and standard mask anesthesia in certain patients. It is introduced into the hypopharynx to form a seal around the larynx thus permitting spontaneous or positive pressure ventilation without penetration of the larynx or esophagus. It is used in place of a facemask in routine anesthesia. The advantages over standard mask anesthesia are better airway control, minimal anesthetic gas leakage, a secure airway during patient transport to the recovery area, and minimal postoperative problems.
Removal of an endotracheal tube from the patient.
A mutation named with the blend of insertion and deletion. It refers to a length difference between two ALLELES where it is unknowable if the difference was originally caused by a SEQUENCE INSERTION or by a SEQUENCE DELETION. If the number of nucleotides in the insertion/deletion is not divisible by three, and it occurs in a protein coding region, it is also a FRAMESHIFT MUTATION.
Insertion of a catheter into a peripheral artery, vein, or airway for diagnostic or therapeutic purposes.
Surgical procedure by which a tendon is incised at its insertion and placed at an anatomical site distant from the original insertion. The tendon remains attached at the point of origin and takes over the function of a muscle inactivated by trauma or disease.
Asthma COPD Cystic Fibrosis Pneumonia Pulmonary Medicine Respiratory Respiratory tract infections (RTIs) are any infection of the sinuses, throat, airways or lungs. They're usually caused by viruses, but they can also ...
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...
An anesthesiologist (US English) or anaesthetist (British English) is a physician trained in anesthesia and perioperative medicine. Anesthesiologists are physicians who provide medical care to patients in a wide variety of (usually acute) situations. ...