Contact information
Type
Scientific
Primary contact
Dr Giovanna Chidini
ORCID ID
Contact details
via della Commenda 9
Milan
20122
Italy
giovannachid@libero.it
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
01
Study information
Scientific title
Acronym
HCPAP
Study hypothesis
Noninvasive continuous positive airway pressure represents a safe and effective means of treating cooperative patients with acute respiratory failure, improving gas exchange, and reducing the rate of complications related to conventional mechanical ventilation. However, 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 non-invasive respiratory treatment. The most common interfaces used in infants and children are nasal prongs and facial masks. The most important principle in guiding the selection of an interface is that it should fit comfortably. However, while the nasal masks can leak gas when the infant opens its mouth, the facial masks can cause significant gastric distension and a tendency for infants to vomit, with the potential risk of aspirating gastric contents. The various 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 ventilatory treatment. Thus, improving the interface between the patient and the ventilator would be expected to facilitate longer, more effective application of non-invasive respiratory support ventilation. A new small helmet designed for young infants has been recently introduced to administer Continuous Positive Airway Pressure (CPAP). The purpose of this study was to investigate the effectiveness of helmet CPAP in terms of tolerance and gas exchange as an alternative to more conventional CPAP full face mask system in infants needing continuous positive airway pressure.
Ethics approval
Ethics Committee at Mangiagalli and Queen Elena Hospital Foundation (c/o Dr Isabella Damilano), approved on 21 December 2005.
Study design
Prospective, randomized physiological cross-over study that included within-partecipant comparison.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Acute respiratory failure, hypoxemic
Intervention
Each infant was randomized to treatment with either helmet or mask CPAP (duration: 90 min). Then the infant was treated with the other CPAP (i.e. those who had been treated with helmet CPAP in the initial phase of the trial were then treated with mask CPAP in the second phase, and vice versa). Each CPAP trial phase was preceded by a 30 min unassisted spontaneous breathing period on oxygen therapy delivered by the Venturi mask.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Tolerance
Secondary outcome measures
1. Gas exchange
2. Respiratory effort
Overall trial start date
01/01/2007
Overall trial end date
01/01/2009
Reason abandoned
Eligibility
Participant inclusion criteria
Acute respiratory distress including the following:
1. PaO2:FiO2 <300 mmHg
2. Bilateral lung infiltrates on chest x-ray
3. Age <2 years
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
20
Participant exclusion criteria
1. Underlying chronic lung disease, such as bronchopulmonary dysplasia and cystic fibrosis
2. Inability to clear major tracheal secretions
3. Requirement for emergency intubation including persistent apnea or cardiopulmonary resuscitation
4. Cardiac disease
5. Presence of more than two new organ failures
6. Tracheostomy
7. Coma
8. Tecent orogastric surgery
Recruitment start date
01/01/2007
Recruitment end date
01/01/2009
Locations
Countries of recruitment
Italy
Trial participating centre
via della Commenda 9
Milan
20122
Italy
Sponsor information
Organisation
Mangiagalli and Queen Elena Hospital Foundation (Italy)
Sponsor details
via Francesco Sforza 35
Milan
20122
Italy
edoardo.calderini@icp.mi.it
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Internally funded by the Mangiagalli and Queen Elena Hospital Foundation (Italy)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary