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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:
Collaborator:
Azienda Ospedaliero-Universitaria di Parma
Information provided by (Responsible Party):
Guido Fanelli, University of Parma
ClinicalTrials.gov Identifier:
NCT00944437
First received: July 21, 2009
Last updated: November 4, 2013
Last verified: November 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 University of Parma:

Primary Outcome Measures:
  • Differences in PaO2/FiO2 ratio with respect to baseline (before NIV) values. [ Time Frame: 24 h ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PaO2/FiO2 improvement at 1 h after beginning of ventilation. [ Time Frame: 1 h after enrollment ] [ Designated as safety issue: No ]
  • Arterial carbon dioxide partial pressure (PaCO2) [ Time Frame: At 1 and 24 h post-enrollment ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Need for intubation [ Time Frame: Up to 24 h post-enrollment ] [ Designated as safety issue: No ]
  • Intensive care unit stay [ Time Frame: Up to 30 days ] [ Designated as safety issue: Yes ]
  • In-hospital mortality [ Time Frame: Up to 30 days ] [ Designated as safety issue: Yes ]
  • Device-related complications: pressure sores, skin necrosis, air leak, eye inflammation, gastric distension. [ Time Frame: Up to 24 h post-enrollment ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: July 21, 2009
Last Updated: November 4, 2013
Health Authority: Italy: Ethics Committee
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Italy: The Italian Medicines Agency

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

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

ClinicalTrials.gov processed this record on November 27, 2014