Noninvasive Continuous Positive Airway Pressure (NCPAP) in Children

NCT01242150 | Completed Phase 3 DMC

• 1 other identifier: GCHNN16011968
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

Brief Summary

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).

Conditions

Acute Respiratory Failure

Keywords

Acute Respiratory Failure; Continuous Positive Airway Pressure; Infants; Helmet

Outcome Measures

Primary Outcomes (1)

• The primary outcome variable is the number of treatment failure in each nCPAP group.

  1 year

Secondary Outcomes (1)

• Gas exchange improvement

  1 year

Study Arms (2)

NCPAP Helmet

EXPERIMENTAL

Infants with mild Acute Respiratory Failure who need NCPAP

Device: NCPAP by helmet

NCPAP facial mask

ACTIVE COMPARATOR

Infants with mild Acute Respiratory failure who need NCPAP

Device: NCPAP by facial mask

Interventions

NCPAP by helmet DEVICE

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.

Also known as: Noninvasive Continuous Positive Airway Pressure by helmet

NCPAP Helmet

NCPAP by facial mask DEVICE

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.

Also known as: Noninvasive Continuous Positive Airway Pressure by mask

NCPAP facial mask

Eligibility Criteria

• Age: 1 Month - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• PaO2/FiO2 ratio \<300
• Respiratory rate \>50 breaths/min
• Chest x-ray compatible with pulmonary infection
• No clinical improvement after breathing oxygen at 8 l/min or more for at least 15 min

You may not qualify if:

• Presence of an endotracheal tube or a tracheostomy before PICU admission
• Facial deformities
• Upper airway obstruction
• Cyanotic congenital heart disease
• Facial trauma
• Recurrent apnea
• Neuromuscular weakness
• Pulmonary hypoplasia
• Pulmonary vascular anomalies
• Imminent respiratory or cardiac arrest
• COPD and/or chronic CO2 retention
• Status asthmaticus
• Pneumothorax
• Hemodynamic instability
• Alteration in consciousness with a Glasgow coma score (GCS) \<10

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (4)

Department of Anesthesia and Intensive Care, Vittore Buzzi Children's Hospital

Milan, Italy

Location

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy

Location

Department of Anesthesia and Intensive Care, Policlinico Gemelli

Rome, Italy

Location

Department of the Environment, Healthy and Safety, University of Insubria

Varese, Italy

Location

Related Publications (2)

• Chidini G, Calderini E, Pelosi P. Treatment of acute hypoxemic respiratory failure with continuous positive airway pressure delivered by a new pediatric helmet in comparison with a standard full face mask: a prospective pilot study. Pediatr Crit Care Med. 2010 Jul;11(4):502-8. doi: 10.1097/PCC.0b013e3181b8063b.

  PMID: 19794328 RESULT

• Chidini G, Calderini E, Cesana BM, Gandini C, Prandi E, Pelosi P. Noninvasive continuous positive airway pressure in acute respiratory failure: helmet versus facial mask. Pediatrics. 2010 Aug;126(2):e330-6. doi: 10.1542/peds.2009-3357. Epub 2010 Jul 26.

  PMID: 20660548 RESULT

Study Officials

• Giovanna Chidini, MD

  Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 14, 2010
• First Posted: November 16, 2010
• Study Start: December 1, 2008
• Primary Completion: September 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 22, 2014

Record last verified: 2014-01

Locations

IT (4)