Non-invasive Ventilation in Terminally Ill Cancer Patients
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Cancer |
Other: non invasive ventilation (NIV) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (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 |
- dyspnea [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
- morphine dosage [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
- Quality of Life [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
- Arterial Blood Gases [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
- Survival [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
| Enrollment: | 200 |
| Study Start Date: | September 2007 |
| Study Completion Date: | August 2011 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| Italy | |
| San'Orsola Malpighi Hospital, Bologna ITALY | |
| Bologna, Italy, 40138 | |
| Principal Investigator: | Stefano Nava | San'Orsola Malpighi Hospital, Bologna ITALY |
More Information
No publications provided by Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | dr. Stefano Nava, Chief ICU, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi |
| ClinicalTrials.gov Identifier: | NCT00533143 History of Changes |
| Other Study ID Numbers: | 322 CEC |
| Study First Received: | September 20, 2007 |
| Last Updated: | July 16, 2012 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi:
|
Solid cancer patient Non-invasive ventilation Acute Respiratory Failure |
Additional relevant MeSH terms:
|
Respiratory Insufficiency Respiration Disorders Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 21, 2013