This randomized clinical trial studies how well non-invasive ventilation works in reducing the need for intubation, or placement of a tube in the windpipe, in patients with cancer and respiratory failure. Respiratory failure is a condition in which not enough oxygen passes from the lungs to the blood, and is a common cause of admission to the emergency room in patients with hematological and solid tumor patients. Non-invasive positive pressure ventilation (NIPPV) is a method of delivering oxygen using a mask. It is not yet known whether NIPPV is better at improving the amount of oxygen in the blood, reducing shortness of breath, and the need for intubation than standard high flow oxygen (a tube with 2 prongs placed in the nostrils) in patients with cancer and respiratory failure.

Brief Title

Non-invasive Ventilation in Reducing the Need for Intubation in Patients With Cancer and Respiratory Failure

Official Title

A Prospective Randomized Controlled Trial of Early Non-Invasive Positive Pressure Ventilation in Patients With Hypoxemic Respiratory Failure and Malignancies

Brief Summary

This randomized clinical trial studies how well non-invasive ventilation works in reducing <br /> the need for intubation, or placement of a tube in the windpipe, in patients with cancer and <br /> respiratory failure. Respiratory failure is a condition in which not enough oxygen passes <br /> from the lungs to the blood, and is a common cause of admission to the emergency room in <br /> patients with hematological and solid tumor patients. Non-invasive positive pressure <br /> ventilation (NIPPV) is a method of delivering oxygen using a mask. It is not yet known <br /> whether NIPPV is better at improving the amount of oxygen in the blood, reducing shortness of <br /> breath, and the need for intubation than standard high flow oxygen (a tube with 2 prongs <br /> placed in the nostrils) in patients with cancer and respiratory failure.

Detailed Description

PRIMARY OBJECTIVES:

I. To determine the percent of patients who meet criteria for intubation within 28 days of
study inclusion.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A (NIPPV THERAPY): Patients undergo intermittent NIPPV, with the recommended schedule
comprising 2 hours on NIPPV followed by =< 2 hours off NIPPV and continuous NIPPV at night or
while sleeping for 8 hours per day, for 28 days or until discharged from the hospital.

ARM B (HIGH FLOW OXYGEN THERAPY): Patients continue to receive high flow nasal cannula oxygen
therapy using current protocol for titration of high flow oxygen therapy for 28 days or until
discharged from the hospital. Patients may receive NIPPV if they develop evidence of
accessory muscle use with breathing or at the discretion of the treating physician.

IDIOPATHIC PULMONARY SYNDROME (IPS) SUBGROUP (INCLUDING DIFFUSE ALVEOLAR HEMORRHAGE):
Patients with IPS receive methylprednisolone daily on days 0-48 and every other day (QOD) on
days 49-55 in parallel with NIPPV or oxygen therapy, with a taper at the discretion of the
treating physician.

After completion of study, patients are followed up until day 100.

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Inclusion Criteria:

  -  Partial pressure of arterial oxygen (PaO2):fraction of inspired oxygen (FiO2) ratio =<
     300 mmHg OR a peripheral capillary oxygen saturation (SaO2):FiO2 =< 357

  -  Have a diagnosed malignancy

  -  Chest radiograph or computed tomography (CT) scan within =< 3 months prior to study
     enrollment rules out primary or metastatic malignancy in the lungs or pleural space as
     a significant cause of respiratory insufficiency

  -  Probability of survival is at least 6 months

Exclusion Criteria:

  -  Presence of do not resuscitate (DNR)/do not intubate (DNI) orders at study entry

  -  Clinical evidence of left heart failure as the main etiology for respiratory
     compromise

  -  Evidence of active intrathoracic malignancy (primary or metastatic) in the lungs or
     pleural space that is a significant cause of respiratory insufficiency

  -  Patients with acute chronic obstructive disease exacerbation as the primary etiology
     for respiratory failure

  -  Evidence of accessory respiratory muscle use with breathing

  -  Shock (need for vasopressor therapy or mean arterial pressure [MAP] < 60 despite fluid
     administration)

  -  Oliguric acute renal failure (urine output < 500 ml/day) unless already on
     hemodialysis

  -  Patient already on NIPPV at the time of screening

  -  pH < 7.30 or partial pressure of carbon dioxide (pCO2) > 50 (if available)

  -  Fixed upper airway obstruction

  -  Airway or facial trauma that would hinder the use of a NIPPV mask

  -  Uncontrolled tachy or bradyarrhythmia or active myocardial ischemia defined as either:
     atrial fibrillation with rapid ventricular response (heart rate [HR] > 120 beats per
     minute [bpm]), ventricular tachycardia or nonsustained ventricular tachycardia (any
     rate), supraventricular tachycardia (any rate), third degree heart block (any rate),
     heart rate less than 40 beats per minute (regardless of the rhythm)

  -  Active myocardial ischemia defined as a clinical presentation at the time of screening
     consistent with acute coronary syndrome which includes unstable angina and
     electrocardiogram (EKG) changes suggestive of an either an acute ST elevation
     myocardial infarction (new ST elevations or new left bundle branch block) or acute
     non-ST elevation myocardial infarction (new ST depressions, new T wave inversions)

  -  Glasgow Coma Scale (GCS) < 8 or inadequate airway protective reflexes

  -  Undrained pneumothorax/pneumomediastinum

  -  Copious secretions (> 20 cc's of sputum production per hour or significant hemoptysis
     defined as > 100 cc's of hemoptysis in a 24 hour period

  -  Risk for gastric aspiration (ie; ileus, esophageal or bowel obstruction, active
     vomiting)

  -  Recent esophageal, gastric or bowel surgery (within 3 weeks of study enrollment)

  -  Inability to cooperate with NIPPV

  -  Refusal to receive NIPPV

  -  Respiratory arrest