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

Email	giovannachid@libero.it

Study information

Study design	Prospective, randomized physiological cross-over study that included within-partecipant comparison.
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	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
Study acronym	HCPAP
Study objectives	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(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) studied	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
Primary outcome measure	Tolerance
Secondary outcome measures	1. Gas exchange 2. Respiratory effort
Overall study start date	01/01/2007
Completion date	01/01/2009

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	Both
Target number of participants	20
Total final enrolment	20
Key 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
Key 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
Date of first enrolment	01/01/2007
Date of final enrolment	01/01/2009

Locations

Countries of recruitment

Italy

Study participating centre

via della Commenda 9

Milan
20122
Italy

Sponsor information

Mangiagalli and Queen Elena Hospital Foundation (Italy)
Hospital/treatment centre

via Francesco Sforza 35
Milan
20122
Italy

Email	edoardo.calderini@icp.mi.it
Website	http://www.policlinico.mi.it/
"ROR"	https://ror.org/016zn0y21

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 share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not 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.