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Noninvasive Continuous Positive Airway Pressure (NCPAP) in Children

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
ClinicalTrials.gov Identifier:
NCT01242150
First received: November 14, 2010
Last updated: November 17, 2010
Last verified: September 2010
History of Changes
  Purpose

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).


Condition Intervention Phase
Acute Respiratory Failure
 Device: NCPAP by helmet
Device: NCPAP by facial mask
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico:

Primary Outcome Measures:
  • The primary outcome variable is the number of treatment failure in each nCPAP group. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Gas exchange improvement [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: December 2008
Estimated Study Completion Date: May 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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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  Eligibility

Ages Eligible for Study:   1 Month to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Aspiration or excessive bronchial secretions
  • Enrollment in other research protocol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01242150

Contacts
Contact: Giovanna Chidini, MD +39-2-55032242 giovannachid@libero.it

Locations
Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Recruiting
Milan, Italy
Contact: Giovanna Chidini, MD     +39-2-55032584     giovannachid@libero.it    
Principal Investigator: Giovanna Chidini, MD            
Department of Anesthesia and Intensive Care, Vittore Buzzi Children's Hospital Recruiting
Milan, Italy
Principal Investigator: Andrea M Wolfler, MD            
Department of Anesthesia and Intensive Care, Policlinico Gemelli Recruiting
Rom, Italy
Principal Investigator: Giorgio Conti, MD            
Department of the Environment, Healthy and Safety, University of Insubria Active, not recruiting
Varese, Italy
Sponsors and Collaborators
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Investigators
Principal Investigator: Giovanna Chidini, MD Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
  More Information

Publications:

Responsible Party: Giovanna Chidini MD, Fondazione IRCCS Policlinico Ospedale Maggiore Ca' Granda, Department of Anesthesia and Intensive Care
ClinicalTrials.gov Identifier: NCT01242150     History of Changes
Other Study ID Numbers: GCHNN16011968
Study First Received: November 14, 2010
Last Updated: November 17, 2010
Health Authority: Italy: Ministry of Health

Keywords provided by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico:
Acute Respiratory Failure
Continuous Positive Airway Pressure
Infants
Helmet

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders

ClinicalTrials.gov processed this record on May 16, 2013