Continuous Positive Airway Pressure (CPAP) Ventilation Using a Novel Full-Face Mask Versus Conventional Helmet

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00944437
• Date of registration: 21/07/2009
• Primary sponsor: University of Parma
• Public title: Continuous Positive Airway Pressure (CPAP) Ventilation Using a Novel Full-Face Mask Versus Conventional Helmet
• Scientific title: Noninvasive Ventilation For Postoperative Acute Respiratory Failure: Comparison of Conventional Helmet With a Novel Full-Face Mask.
• Date of first enrolment: May 2008
• Target sample size: 50
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00944437
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Italy

Contacts

• Name: Marco Baciarello, MD

• Name: Maria Barbagallo, MD

• Name: Guido Fanelli, MD
• Affiliation: Dept. of Anesthesiology and Critical Care Medicine, University of Parma, Italy

• Name: Maria Barbagallo, MD
• Affiliation: UO II Anestesia, Rianimazione e Terapia Antalgica, Azienda Ospedaliero-Universitaria di Parma

Key inclusion & exclusion criteria

Inclusion Criteria:

- Ongoing or recent history of respiratory failure (either primary or secondary)

- PaO2 <60 mmHg if breathing room air or PaO2/FiO2 <300 mmHg if receiving supplemental
oxygen

- Acute dyspnea with respiratory rate >25 bpm and accessory muscle recruitment and/or
paradoxical abdominal breathing

Exclusion Criteria:

- Refusing noninvasive ventilation

- Comatose (Glasgow Coma Scale <8) or unable to maintain a patent airway

- Hemodynamically unstable (systolic blood pressure <80 mmHg on recruitment, or
receiving vasopressors/inotropes; ongoing angina/myocardial infarction;
newly-developed arrhythmia with hemodynamic impact)

- Having recently (=2 weeks) undergone oesophageal or upper respiratory tract surgery



Age minimum: 18 Years
Age maximum: 89 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Obstructive Pulmonary Disease

Pulmonary Edema

Respiratory Distress Syndrome, Adult

Respiratory Insufficiency

Intervention(s)

Device: Full-face mask

Device: Helmet

Primary Outcome(s)

Differences in PaO2/FiO2 ratio with respect to baseline (before NIV) values. [Time Frame: 24 h]

Secondary Outcome(s)

Arterial blood pressure and incidence of hypotension (systolic blood pressure <90 mmHg or mean arterial blood pressure <60 mmHg) [Time Frame: Up to 24 h post-enrollment]

Arterial carbon dioxide partial pressure (PaCO2) [Time Frame: At 1 and 24 h post-enrollment]

Device-related complications: pressure sores, skin necrosis, air leak, eye inflammation, gastric distension. [Time Frame: Up to 24 h post-enrollment]

In-hospital mortality [Time Frame: Up to 30 days]

Intensive care unit stay [Time Frame: Up to 30 days]

Need for intubation [Time Frame: Up to 24 h post-enrollment]

PaO2/FiO2 improvement at 1 h after beginning of ventilation. [Time Frame: 1 h after enrollment]

Patient's rating of comfort with the device. Numerical rating scale ranging from 1 (unbearable) to 5 (very good.) [Time Frame: At 1 and 24 h post-enrollment]

Success rate of NIV as delivered with either helmet or full-face mask. Success is defined as =50 mmHg improvement of PaO2/FiO2 ratio. [Time Frame: 24 h from initiation of therapy]

Secondary ID(s)

ICU-ICU-02

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Azienda Ospedaliero-Universitaria di Parma