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Non-invasive Ventilation in Terminally Ill Cancer Patients

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. Identifier: NCT00533143
Recruitment Status : Completed
First Posted : September 21, 2007
Last Update Posted : July 17, 2012
Information provided by (Responsible Party):
dr. Stefano Nava, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Brief Summary:

The occurrence of acute respiratory failure (ARF) is often seen by oncologists as a terminal phase of the disease, this view being based on studies reporting limited survival at considerable costs in such patients. A large proportion of cancer patients with severe respiratory failure are denied admission to an ICU because intensive care specialists are aware that intubation and mechanical ventilation are both strong predictors of mortality in critically ill cancer patients. This holds particularly true in the subset of patients who are not receiving chemotherapy or radiotherapy because of the advanced stage of their disease, and who are also not affected by an episode of ARF, related to a reversible cause.

These patients often receive oxygen therapy and morphine in an attempt to improve oxygenation and/or relieve the ensuing dyspnea.

Non-invasive mechanical ventilation (NIV) is now the first line treatment of ARF in selected populations (e.g., those with COPD) and has been used sporadically as a potential treatment of acute respiratory failure in patients with a "do-not-intubate" order. The International Consensus Conference on Intensive Care Medicine stated that "the use of NIV may be justified in selected patients who are "not to be intubated" and may provide patient comfort and facilitate physician-patient interaction." "Early" NIV has been successfully used so far in cancer patients only to prevent intubation among those with hematologic malignancies, while a pilot study has assessed the feasibility of NIV also as a "palliative" treatment of end-stage solid cancer patients. So far we are lacking data about the "pure palliative" effects of NIV,in patients with end-stage solid cancer.

The aim of this multicenter randomised study will be to evaluate on a large scale the feasibility, clinical efficacy and impact on quality of life and dyspnea of NIV versus standard medical in patients with respiratory failure, not related to a reversible cause, and solid cancer needing palliative care treatment.

Condition or disease Intervention/treatment Phase
Cancer Other: non invasive ventilation (NIV) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: Multicenter, Randomised Study of the Use of Non-Invasive Ventilation (NIV) Versus Oxygen Therapy (O2) in Reducing Dyspnea in End-stage Solid Cancer Patients With Respiratory Failure and Distress
Study Start Date : September 2007
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 2
Non-invasive ventilation
Other: non invasive ventilation (NIV)
NIV is a form of mechanical ventilation delivered through a face or nasal mask and therefore not requiring endotracheal intubation. It will be delivered according to the compliance and tolerance of the patients.
Other Name: oxygen therapy

Primary Outcome Measures :
  1. dyspnea [ Time Frame: 48 hours ]
  2. morphine dosage [ Time Frame: 48 hours ]
  3. Quality of Life [ Time Frame: 48 hours ]

Secondary Outcome Measures :
  1. Arterial Blood Gases [ Time Frame: 48 hours ]
  2. Survival [ Time Frame: 48 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Major criteria for enrollment into the study were one of the following:

  • PaO2/FiO2 ratio < 250 + one of the two following:

    • dyspnea with recruitment of the accessory muscles and/or abdominal muscles recruitment; and
    • respiratory rate > 30 b/ min. Hypercapnia per se is not a criteria of inclusion, but it is not an exclusion criteria if chronic.

Exclusion Criteria:

  • Potentially reversible causes of exacerbation such as (CPE, pneumonia or exacerbation of chronic pulmonary disorders) coma
  • Refusal of treatment
  • Inability to protect the airways
  • An agitated or uncooperative patient
  • Anatomical abnormalities interfering with mask fit
  • Uncontrolled cardiac ischemia or arrhythmias
  • Failure of more than two organs

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 identifier (NCT number): NCT00533143

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San'Orsola Malpighi Hospital, Bologna ITALY
Bologna, Italy, 40138
Sponsors and Collaborators
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
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Principal Investigator: Stefano Nava San'Orsola Malpighi Hospital, Bologna ITALY
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: dr. Stefano Nava, Chief ICU, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi Identifier: NCT00533143    
Other Study ID Numbers: 322 CEC
First Posted: September 21, 2007    Key Record Dates
Last Update Posted: July 17, 2012
Last Verified: July 2012
Keywords provided by dr. Stefano Nava, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi:
Solid cancer patient
Non-invasive ventilation
Acute Respiratory Failure
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases