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Clinical Efficacy of a Cephalic Mask for Noninvasive Ventilation During Acute Hypercapnic Respiratory Failure

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00213395
Enrollment
Unknown
Registered
2005-09-21
Start date
2004-10-31
Completion date
2006-02-28
Last updated
2012-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Hypercapnic Respiratory Failure

Keywords

Noninvasive ventilation, Acute hypercapnic respiratory failure, Cephalic mask, Facial Mask

Brief summary

Noninvasive ventilation (NIV) is now a major therapeutic option to manage patients with acute hypercapnic respiratory failure (AHRF). Otherwise, patient-ventilator interfaces are determinant to get an optimal NIV efficacy in parallel with ventilatory comfort. Facial masks during NIV are associated with deleterious consequences like gas leaks around the mask, skin breakdown (especially on the nasal bridge), claustrophobia and mask discomfort. In order to limit these side effects, a cephalic interface has been recently designed. Cephalic mask covers the whole anterior surface of the face and excessive mask fit pressure is therefore spread over a larger surface outside the nose area. However, this mask has a high volume that may interfere with NIV efficacy and may also induce claustrophobic sensations. The aim of this study is to compare the clinical efficacy and tolerance of a cephalic mask versus a conventional oronasal mask during AHRF.

Interventions

DEVICEInterface for noninvasive ventilation

Sponsors

University Hospital, Rouen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Acute hypercapnic respiratory failure * Indication to noninvasive ventilation

Exclusion criteria

* Requirement for endotracheal intubation * Proven pulmonary embolism * Present or previous history of ophthalmologic disease

Design outcomes

Primary

MeasureTime frame
Arterial blood gases

Secondary

MeasureTime frame
Severity scores
Ventilatory settings
Patient-ventilator adaptation
Respiratory frequency
Outcome
Complications
Tolerance

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026