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

NCT00944437 | Terminated

• 1 other identifier: ICU-ICU-02
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Respiratory Insufficiency; Respiratory Distress Syndrome, Adult; Chronic Obstructive Pulmonary Disease; Pulmonary Edema

Keywords

Ventilation, Mechanical; Positive-Pressure Respiration; Continuous Positive Airway Pressure

Outcome Measures

Primary Outcomes (1)

• Differences in PaO2/FiO2 ratio with respect to baseline (before NIV) values.

  24 h

Secondary Outcomes (9)

• PaO2/FiO2 improvement at 1 h after beginning of ventilation.

  1 h after enrollment

• Arterial carbon dioxide partial pressure (PaCO2)

  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)

  Up to 24 h post-enrollment

• Need for intubation

  Up to 24 h post-enrollment

• Intensive care unit stay

  Up to 30 days

Study Arms (2)

Helmet

ACTIVE COMPARATOR

Patients in this group will receive continuous positive airway pressure delivered through a helmet connected to a high-flow reservoir system.

Device: Helmet

Mask

EXPERIMENTAL

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

Interventions

Helmet DEVICE

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%.

Also known as: Continuous Positive Airway Pressure, Noninvasive Ventilation, 4-Vent helmet (Rüsch, Germany)

Helmet

Full-face mask DEVICE

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%.

Also known as: Continuous Positive Airway Pressure, Noninvasive Ventilation, Novastar mask (Dräger GmbH, Lubeck, Germany)

Mask

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Parma: lead
• Azienda Ospedaliero-Universitaria di Parma: collaborator

Study Sites (1)

University and Hospital of Parma (Azienda Ospedaliero-Universitaria di Parma)

Parma, PR, 43126, Italy

Location

Related Publications (9)

• 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. doi: 10.1164/ajrccm.149.5.8173743.

  PMID: 8173743 BACKGROUND

• 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. doi: 10.1378/chest.114.6.1636.

  PMID: 9872200 BACKGROUND

• 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. doi: 10.1385/NCC:1:4:429.

  PMID: 16174945 BACKGROUND

• 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.

  PMID: 16438899 BACKGROUND

• 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. doi: 10.1097/01.ccm.0000148011.51681.e2.

  PMID: 15599160 BACKGROUND

• 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. doi: 10.1164/ajrccm.151.6.7767523.

  PMID: 7767523 BACKGROUND

• Masip J, Roque M, Sanchez B, Fernandez R, Subirana M, Exposito JA. Noninvasive ventilation in acute cardiogenic pulmonary edema: systematic review and meta-analysis. JAMA. 2005 Dec 28;294(24):3124-30. doi: 10.1001/jama.294.24.3124.

  PMID: 16380593 BACKGROUND

• 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. doi: 10.1378/chest.109.1.179.

  PMID: 8549183 BACKGROUND

• 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.

  PMID: 7924369 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency; Respiratory Distress Syndrome; Pulmonary Disease, Chronic Obstructive; Pulmonary Edema; Respiratory Aspiration

Interventions

Head Protective Devices; Continuous Positive Airway Pressure; Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Personal Protective Equipment; Protective Devices; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture; Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Guido Fanelli, MD

  Dept. of Anesthesiology and Critical Care Medicine, University of Parma, Italy

  STUDY CHAIR

• Maria Barbagallo, MD

  UO II Anestesia, Rianimazione e Terapia Antalgica, Azienda Ospedaliero-Universitaria di Parma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology and Director, Anesthesia, Critical Care and Pain Medicine

Study Record Dates

• First Submitted: July 21, 2009
• First Posted: July 23, 2009
• Study Start: May 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: November 5, 2013

Record last verified: 2013-11

Locations

IT (1)