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NCT00213395 Clinical Trial

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

Acute Hypercapnic Respiratory Failure Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00213395
Other study ID # 2004/015/HP
Secondary ID
Status Terminated
Phase N/A
First received September 13, 2005
Last updated February 14, 2012
Start date October 2004
Est. completion date February 2006

Study information
Verified date February 2012
Source University Hospital, Rouen
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 0
Est. completion date February 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Interface for noninvasive ventilation

Locations
Country Name City State
France Pulmonary & Intensive Care Department - Rouen University Hospital, Rouen

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Arterial blood gases
Secondary Respiratory frequency
Secondary Severity scores
Secondary Ventilatory settings
Secondary Patient-ventilator adaptation
Secondary Tolerance
Secondary Outcome
Secondary Complications
See also
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Completed NCT04102735 - Under the Nose Face Mask to Prevent Facial Pressure Ulcers During NIV for Acute Hypercapnic Respiratory Failure (AHRF) N/A
Not yet recruiting NCT06064409 - Optimal Timing and Failure Prediction of High Flow Nasal Cannula Oxygen Therapy in Emergency Department: Prospective Observational Single Center Study
Terminated NCT04650412 - Integrated Care of Co-morbidities vs Standard Care After AHRF in the Intensive Care Unit N/A
Active, not recruiting NCT06374589 - Closed-Loop O2 Use During High Flow Oxygen Treatment Of Critical Care Adult Patients (CLOUDHFOT) N/A
Recruiting NCT04640948 - High VS Low Flow Nasal O2 for Acute Hypercapnic Respiratory Failure N/A
Completed NCT02538263 - Volume-targeted Versus Pressure-limited Noninvasive Ventilation in Patients With Acute Hypercapnic Respiratory Failure N/A
Recruiting NCT06204276 - Asymmetrical Versus Conventional High-flow Nasal Cannula in Acute Respiratory Failure N/A
Not yet recruiting NCT03756415 - CO2 Clearance During Noninvasive Ventilation (NIV) N/A
Recruiting NCT06108284 - Impact of Negative Pressure Ventilation in Patients Hospitalized With Acute Hypercapnic Respiratory Failure N/A
Not yet recruiting NCT05674760 - ReAcT CO2: A Study to Assess TcCO2 to Guide Acute NIV N/A
Recruiting NCT05513508 - The ROTAtional-USE of Interface STUDY N/A
Recruiting NCT03642002 - The Effects of Music Therapy on Adult Patients Requiring Mechanical Ventilation in the ICU N/A
Not yet recruiting NCT04362787 - High Pressure Non Invasive Ventilation in Hypercapnic Respiratory Failure
Completed NCT04109560 - HFNC and Acute Hypercapnic Respiratory Failure