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Severe Acute Respiratory Failure in Hematology and Cancer Patients Without Bronchoalveolar Lavage. A Multicentric Randomized Controlled Trial

Phase 3
18 Years
Not Enrolling
Lymphoma, Cancer, Acute Respiratory Failure, Leukemia

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Trial Information

Severe Acute Respiratory Failure in Hematology and Cancer Patients Without Bronchoalveolar Lavage. A Multicentric Randomized Controlled Trial

Acute respiratory failure is a dreadful complication in cancer patients. Indeed, about 20%
of the patients will present with pulmonary infiltrates, but Intensive Care Unit (ICU)
admission and mechanical ventilation will be needed in half of them resulting in mortality
for most of the patients. Managing cancer patients with respiratory failure implicates three
mandatory tasks: 1) early antibiotics administration covering suspected pathogens; 2) search
for the actual aetiology; and 3) adequate supportive care with access to invasive or non
invasive respiratory support. Performing the etiological diagnosis is crucial. Fiberoptic
bronchoscopy and bronchoalveolar lavage (FO-BAL) remains the cornerstone of the management
of pulmonary infiltrates in cancer patients. However, non-invasive diagnostic tools have
been validated in the recent years. Diagnostic and therapeutic impacts of FO-BAL are only of
30% to 60% and 15% to 60% respectively. In neutropenic patients and recipients of bone
marrow or stem cell transplantation, this impact is significantly altered. Moreover, reports
have highlighted significant rates of complications such as haemorrhage (5%), respiratory
deterioration (11% to 40%), possibly heading to intubation and subsequent death. Therefore,
balancing advantages to risks of FO-BAL is in order. The MiniMax® study is a multicenter
randomized controlled study aimed at demonstrating that a combination of non-invasive
diagnostic tools are as effective as FO-BAL in performing the etiological diagnosis of acute
respiratory failure in cancer patients. In addition, these non-invasive tests might not lead
to deterioration of the respiratory status and corresponding requirement to intubation and
mechanical ventilation. The group of investigators is used to manage cancer patients with
pulmonary involvement. In the 21 centres, patients will be randomized to be managed either
with FO-BAL or with only non-invasive tools. In each case, patients will be managed with the
best supportive care including adequate antibiotics, respiratory support and all needed life
sustaining therapies. Our hypothesis is to reduce intubation rate using a non-invasive
approach (without FO-LBA). Surrogate markers will be hospital mortality and the number of
diagnostic procedures in each group of patients.

Inclusion Criteria:

- Patients with a malignant haemopathy or a cancer

- Patients with severe acute respiratory failure requiring admission to an ICU

- No argument for a congestive cardiac insufficiency (heart failure)

- Patients who provided their informed consent

Exclusion Criteria:

- Age less than 18

- Patient who refuses to undergo fiberoptic bronchoscopy

- Therapeutic limitation

- Patients intubated at ICU admission

- Etiological diagnosis of the acute respiratory failure known

- Lack of available bronchoscopy


- Post-operative direct admission

- Inclusion in another research protocol in the ICU (HURRIET law)

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Reduction in intubation rate

Outcome Time Frame:

28 days

Safety Issue:


Principal Investigator

Elie Azoulay, MD,PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Assistance Publique - Hôpitaux de Paris


France: Ministry of Health

Study ID:




Start Date:

August 2005

Completion Date:

August 2008

Related Keywords:

  • Lymphoma
  • Cancer
  • Acute Respiratory Failure
  • Leukemia
  • Haematology and cancer patients
  • Acute respiratory failure
  • Bronchoalveolar lavage
  • Non invasive diagnostic tools
  • Mechanical ventilation
  • Intensive Care
  • Leukemia
  • Lymphoma
  • Respiratory Distress Syndrome, Adult
  • Respiratory Insufficiency