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

This study has been terminated.
(Failed to reach expected enrollment by anticipated dates.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00944437
First Posted: July 23, 2009
Last Update Posted: November 5, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Azienda Ospedaliero-Universitaria di Parma
Information provided by (Responsible Party):
Guido Fanelli, University of Parma
  Purpose

The aim of this study is to compare two methods of delivery of noninvasive mechanical ventilation (NIV).

Since patient compliance and mechanical characteristics of the delivery devices are two fundamental variables in the success of NIV during acute respiratory failure, our hypothesis is that an improved patient-ventilator interface may improve the efficacy of therapy.


Condition Intervention
Respiratory Insufficiency Respiratory Distress Syndrome, Adult Chronic Obstructive Pulmonary Disease Pulmonary Edema Device: Helmet Device: Full-face mask

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Noninvasive Ventilation For Postoperative Acute Respiratory Failure: Comparison of Conventional Helmet With a Novel Full-Face Mask.

Resource links provided by NLM:


Further study details as provided by Guido Fanelli, University of Parma:

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

Secondary Outcome Measures:
  • PaO2/FiO2 improvement at 1 h after beginning of ventilation. [ Time Frame: 1 h after enrollment ]
  • Arterial carbon dioxide partial pressure (PaCO2) [ Time Frame: At 1 and 24 h post-enrollment ]
  • 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 ]
  • Need for intubation [ Time Frame: Up to 24 h post-enrollment ]
  • Intensive care unit stay [ Time Frame: Up to 30 days ]
  • In-hospital mortality [ Time Frame: Up to 30 days ]
  • Device-related complications: pressure sores, skin necrosis, air leak, eye inflammation, gastric distension. [ Time Frame: Up to 24 h post-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 ]

Enrollment: 23
Study Start Date: May 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Helmet
Patients in this group will receive continuous positive airway pressure delivered through a helmet connected to a high-flow reservoir system.
Device: Helmet
Continuous positive airway pressure for up to 24 h. Initial pressure will be 5 cmH2O, and will be increased by 2-3 cmH2O up to 10 cmH2O, in order to maintain SpO2 ≥90%.
Other Names:
  • Continuous Positive Airway Pressure
  • Noninvasive Ventilation
  • 4-Vent helmet (Rüsch, Germany)
Experimental: Mask
Patients in this group will receive continuous positive-airway pressure delivered through a novel full-face mask connected to a high-flow system. Expiratory pressure will be maintained using an expiratory valve connected to a T-tube.
Device: Full-face mask
Continuous positive airway pressure for up to 24 h. Initial pressure will be 5 cmH2O, and will be increased by 2-3 cmH2O up to 10 cmH2O, in order to maintain SpO2 ≥90%.
Other Names:
  • Continuous Positive Airway Pressure
  • Noninvasive Ventilation
  • Novastar mask (Dräger GmbH, Lubeck, Germany)

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00944437


Locations
Italy
University and Hospital of Parma (Azienda Ospedaliero-Universitaria di Parma)
Parma, PR, Italy, 43126
Sponsors and Collaborators
University of Parma
Azienda Ospedaliero-Universitaria di Parma
Investigators
Study Chair: Guido Fanelli, MD Dept. of Anesthesiology and Critical Care Medicine, University of Parma, Italy
Principal Investigator: Maria Barbagallo, MD UO II Anestesia, Rianimazione e Terapia Antalgica, Azienda Ospedaliero-Universitaria di Parma
  More Information

Publications:

Responsible Party: Guido Fanelli, Professor of Anesthesiology and Director, Anesthesia, Critical Care and Pain Medicine, University of Parma
ClinicalTrials.gov Identifier: NCT00944437     History of Changes
Other Study ID Numbers: ICU-ICU-02
First Submitted: July 21, 2009
First Posted: July 23, 2009
Last Update Posted: November 5, 2013
Last Verified: November 2013

Keywords provided by Guido Fanelli, University of Parma:
Ventilation, Mechanical
Positive-Pressure Respiration
Continuous Positive Airway Pressure

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Pulmonary Edema
Acute Lung Injury
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Lung Injury