Noninvasive Continuous Positive Airway Pressure (NCPAP) in Children (NCPAP)
In critically ill pediatric patients with Acute Respiratory Failure (ARF), Noninvasive Continuous Positive Airway Pressure (NCPAP) is applied to avoid intubation and all related complications such as tracheal injury and predisposition to nosocomial pulmonary infections. The choice of the interface is one of the crucial issues affecting treatment outcome in pediatric age and in particular in preschool children in whom intolerance frequently compromise noninvasive respiratory treatment. NCPAP is applied either through nasal or facial tight fitting masks and the most important principle in guiding the selection of an interface is that it should fit comfortably. However, while nasal mask can leak gas when the infant opens his/her mouth, facial mask can cause significant gastric distension and vomiting, with risk of aspirating gastric contents. Moreover, complications such as air leaks, skin irritation on the bridge of the nose, and discomfort reported with nasal or facial masks in children frequently lead to interruption of the respiratory treatment. Thus, improving the interface between the patient and the ventilator would be expected to facilitate longer and more effective application of NCPAP.
A new small helmet specifically designed for young infants has been recently introduced to administer NCPAP. In a recent short term crossover physiological randomized controlled trial, the investigators found that NCPAP by helmet was associated with enhanced feasibility, less need of sedation and prolonged application time (see references below). The purpose of this prospective randomized multicenter study is to compare the efficacy and feasibility of NCPAP delivered either by helmet or by facial mask to treat acute respiratory failure in infants admitted to Pediatric Intensive Care Unit (PICU).
|Acute Respiratory Failure||Device: NCPAP by helmet Device: NCPAP by facial mask||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Noninvasive Continuous Positive Airway Pressure by Helmet or Facial Mask in Children: a Multicenter Randomized Controlled Study|
- The primary outcome variable is the number of treatment failure in each nCPAP group. [ Time Frame: 1 year ]
- Gas exchange improvement [ Time Frame: 1 year ]
|Study Start Date:||December 2008|
|Study Completion Date:||December 2013|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Experimental: NCPAP Helmet
Infants with mild Acute Respiratory Failure who need NCPAP
Device: NCPAP by helmet
The infant helmet (Castar Starmed© Mirandola, Italy) is secured to a soft collar that adheres to the child's neck and is connected to a high flow NCPAP circuit (high fresh gas flow >40 L/min to avoid carbon dioxide rebreathing). To facilitate tolerance up to a maximum of 2 boluses of midazolam 0.1 mg/kg i.v. can be administered eventually followed by an i.v. continuous infusion rate according to OPS scale. Once the interface is positioned, a baseline Continuous Positive Airway Pressure (CPAP) level is set at 4 cm H2O and then raised in increments of 2 cm H2O every 20 min up to a maximum of 10 cm H2O. FiO2 is set to achieve a SpO2 ≥ 92%. If intolerance persisted despite sedative administration, the alternate interface can be used before considering tracheal intubation. All patients are kept in semirecumbent position.
Other Name: Noninvasive Continuous Positive Airway Pressure by helmet
Active Comparator: NCPAP facial mask
Infants with mild Acute Respiratory failure who need NCPAP
Device: NCPAP by facial mask
The size of NCPAP full face or nasal masks are chosen to be more comfortable for the infants (Respironics, Murrysville). The masks are secured by head straps while avoiding a tight fit and air leaks. A protective hydrocolloid sheet was applied over the nasal bridge (DuoDERM, ConvaTec, Deeside, UK). After a short adaptation period, it is firmly applied on the face by a pediatric head cap (Respironics, Murrysville ) to minimize air leaks. The mask is then connected to the same circuit previously described for helmet NCPAP.
Other Name: Noninvasive Continuous Positive Airway Pressure by mask
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01242150
|Department of Anesthesia and Intensive Care, Vittore Buzzi Children's Hospital|
|Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico|
|Department of Anesthesia and Intensive Care, Policlinico Gemelli|
|Department of the Environment, Healthy and Safety, University of Insubria|
|Principal Investigator:||Giovanna Chidini, MD||Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico|