Non-invasive Ventilation in Terminally Ill Cancer Patients

NCT00533143 | Completed Phase 4 DMC

• 1 other identifier: 322 CEC
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Solid cancer patient; Non-invasive ventilation; Acute Respiratory Failure

Outcome Measures

Primary Outcomes (3)

• dyspnea

  48 hours

• morphine dosage

  48 hours

• Quality of Life

  48 hours

Secondary Outcomes (2)

• Arterial Blood Gases

  48 hours

• Survival

  48 hours

Study Arms (1)

2

EXPERIMENTAL

Non-invasive ventilation

Other: non invasive ventilation (NIV)

Interventions

non invasive ventilation (NIV) OTHER

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.

Also known as: oxygen therapy

2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

San'Orsola Malpighi Hospital, Bologna ITALY

Bologna, 40138, Italy

Location

Related Publications (1)

• Nava S, Ferrer M, Esquinas A, Scala R, Groff P, Cosentini R, Guido D, Lin CH, Cuomo AM, Grassi M. Palliative use of non-invasive ventilation in end-of-life patients with solid tumours: a randomised feasibility trial. Lancet Oncol. 2013 Mar;14(3):219-27. doi: 10.1016/S1470-2045(13)70009-3. Epub 2013 Feb 11.

  PMID: 23406914 DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Noninvasive Ventilation; Oxygen

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy; Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Stefano Nava

  San'Orsola Malpighi Hospital, Bologna ITALY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief ICU

Study Record Dates

• First Submitted: September 20, 2007
• First Posted: September 21, 2007
• Study Start: September 1, 2007
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: July 17, 2012

Record last verified: 2012-07

Locations

IT (1)