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

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:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease) Edema Respiratory Failure

U.S. FDA Resources

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 ]

Estimated Enrollment:	50
Study Start Date:	May 2008
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	December 2009 (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)

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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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00944437

Contacts

Contact: Maria Barbagallo, MD

+39-052-170-3567

mbarbagallo@ao.pr.it

Locations

Italy
University and Hospital of Parma (Azienda Ospedaliero-Universitaria di Parma)	Recruiting
Parma, PR, Italy, 43126
Contact: Marco Baciarello, MD +39-052-103-3477 mbaciarello@parmanesthesia.com
Sub-Investigator: Marco Baciarello, MD
Sub-Investigator: Simone Di Cianni, MD
Sub-Investigator: Maria Rossi, MD
Sub-Investigator: Giada Maspero, MD
Principal Investigator: Maria Barbagallo, MD

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:

Appendini L, Patessio A, Zanaboni S, Carone M, Gukov B, Donner CF, Rossi A. Physiologic effects of positive end-expiratory pressure and mask pressure support during exacerbations of chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1994 May;149(5):1069-76.

Celikel T, Sungur M, Ceyhan B, Karakurt S. Comparison of noninvasive positive pressure ventilation with standard medical therapy in hypercapnic acute respiratory failure. Chest. 1998 Dec;114(6):1636-42.

Chadda K, Clair B, Orlikowski D, Macadoux G, Raphael JC, Lofaso F. Pressure support versus assisted controlled noninvasive ventilation in neuromuscular disease. Neurocrit Care. 2004;1(4):429-34.

Collaborative Research Group of Noninvasive Mechanical Ventilation for Chronic Obstructive Pulmonary Disease. Early use of non-invasive positive pressure ventilation for acute exacerbations of chronic obstructive pulmonary disease: a multicentre randomized controlled trial. Chin Med J (Engl). 2005 Dec 20;118(24):2034-40.

Keenan SP, Sinuff T, Cook DJ, Hill NS. Does noninvasive positive pressure ventilation improve outcome in acute hypoxemic respiratory failure? A systematic review. Crit Care Med. 2004 Dec;32(12):2516-23. Review.

Kramer N, Meyer TJ, Meharg J, Cece RD, Hill NS. Randomized, prospective trial of noninvasive positive pressure ventilation in acute respiratory failure. Am J Respir Crit Care Med. 1995 Jun;151(6):1799-806.

Masip J, Roque M, Sánchez B, Fernández R, Subirana M, Expósito JA. Noninvasive ventilation in acute cardiogenic pulmonary edema: systematic review and meta-analysis. JAMA. 2005 Dec 28;294(24):3124-30. Review.

Meduri GU, Turner RE, Abou-Shala N, Wunderink R, Tolley E. Noninvasive positive pressure ventilation via face mask. First-line intervention in patients with acute hypercapnic and hypoxemic respiratory failure. Chest. 1996 Jan;109(1):179-93.

Meduri GU, Fox RC, Abou-Shala N, Leeper KV, Wunderink RG. Noninvasive mechanical ventilation via face mask in patients with acute respiratory failure who refused endotracheal intubation. Crit Care Med. 1994 Oct;22(10):1584-90.

Responsible Party:	Maria Barbagallo, MD, Azienda Ospedaliero-Universitaria di Parma
ClinicalTrials.gov Identifier:	NCT00944437 History of Changes
Other Study ID Numbers:	ICU-ICU-02
Study First Received:	July 21, 2009
Last Updated:	July 22, 2009
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:

Edema
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Pulmonary Edema
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury

Respiratory Insufficiency
Lung Diseases, Obstructive
Signs and Symptoms
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury

ClinicalTrials.gov processed this record on May 16, 2013