Condition category
Respiratory
Date applied
30/06/2007
Date assigned
30/07/2007
Last edited
30/07/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.policlinico.mi.it/

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

Publication citations

Additional files

Editorial Notes