Noninvasive Continuous Positive Airway Pressure (CPAP) by a new pediatric helmet in infants with acute respiratory failure: A comparison with standard full face mask CPAP system

ISRCTN ISRCTN26963869
DOI https://doi.org/10.1186/ISRCTN26963869
Secondary identifying numbers 01
Submission date
30/06/2007
Registration date
30/07/2007
Last edited
28/10/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Giovanna Chidini
Scientific

via della Commenda 9
Milan
20122
Italy

giovannachid@libero.it

Study information

Study designProspective, randomized physiological cross-over study that included within-partecipant comparison.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleNoninvasive Continuous Positive Airway Pressure (CPAP) by a new pediatric helmet in infants with acute respiratory failure: A comparison with standard full face mask CPAP system
Study acronymHCPAP
Study objectivesNoninvasive 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(s)Ethics Committee at Mangiagalli and Queen Elena Hospital Foundation (c/o Dr Isabella Damilano), approved on 21 December 2005.
Health condition(s) or problem(s) studiedAcute respiratory failure, hypoxemic
InterventionEach 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 typeOther
Primary outcome measureTolerance
Secondary outcome measures1. Gas exchange
2. Respiratory effort
Overall study start date01/01/2007
Completion date01/01/2009

Eligibility

Participant type(s)Patient
Age groupNeonate
SexAll
Target number of participants20
Total final enrolment20
Key inclusion criteriaAcute respiratory distress including the following:
1. PaO2:FiO2 <300 mmHg
2. Bilateral lung infiltrates on chest x-ray
3. Age <2 years
Key exclusion criteria1. 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
Date of first enrolment01/01/2007
Date of final enrolment01/01/2009

Locations

Countries of recruitment

  • Italy

Study participating centre

via della Commenda 9
Milan
20122
Italy

Sponsor information

Funders

Funder type

Hospital/treatment centre

Internally funded by the Mangiagalli and Queen Elena Hospital Foundation (Italy)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 26/07/2010 28/10/2021 Yes No

Editorial Notes

28/10/2021: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.

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