The goal of this clinical research study is to learn whether using early non-invasive
positive pressure ventilation (NIPPV), a method of delivering oxygen using a mask, or high
flow oxygen (using a tube with 2 prongs placed in the nostrils) is better at improving the
amount of oxygen in your blood, reducing shortness of breath, and the need for intubation
(placement of a tube in the windpipe) in patients with cancer and hypoxemia (a low level of
oxygen in the blood).
This is an investigational study. Both NIPPV and high flow oxygen are FDA approved for
hypoxemia. Comparing these procedures in reducing shortness of breath and the need for
intubation is investigational.
Up to 366 participants will be enrolled in this study. All will take part at MD Anderson.
If you agree to take part in this study, you will be randomly assigned (as in the flip of a
coin) to 1 of 2 groups. This is done because no one knows if one study group is better, the
same, or worse than the other group. You will have an equal chance of being in either group:
- If you are in Group 1, you will receive high flow oxygen through your nose.
- If you are in Group 2, you will receive oxygen through a mask (NIPPV). You will also
receive high flow oxygen through your nose, if the doctor thinks it is needed (described
Before you begin treatment and then every 4 hours while you are in the hospital, the study
staff will visit you. At these times, you will have a brief physical exam. This will include
a check on how well you are breathing, how alert you are, and to measure your oxygen levels.
These visits will continue until your hypoxemia improves enough where you no longer need
If your condition worsens and you are in Group 1 and the study doctor thinks it is in your
best interest, you will be allowed to receive oxygen through a NIPPV mask. If you are in
Group 2 and your condition improves or you do not want to wear the mask anymore, you will be
allowed to receive oxygen through your nose.
The study staff will follow your progress by reviewing your medical chart for up to 28 days
after you started the study or until you leave the hospital (whichever comes first). During
this time, the study staff may visit you to learn how well you are tolerating treatment.
Length of Study:
Your participation in this study will be over after 28 days or when you leave the hospital.
Researchers will continue to collect information regarding your health from your medical
records for up to 100 days.
1. Age >/= 18 years old
2. PaO2:FiO2 ratio </= 300 mmHg OR a SpO2:FiO2 </= 357
3. Have a diagnosed malignancy
4. Chest radiograph or 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.
5. Probability of survival is at least 6 months.
1. Presence of DNR/DNI orders at study entry
2. Clinical evidence of left heart failure as the main etiology for respiratory
3. Evidence of active intrathoracic malignancy (primary or metastatic) in the lungs or
pleural space that is a significant cause of respiratory insufficiency
4. Patients with acute chronic obstructive disease exacerbation as the primary etiology
for respiratory failure.
5. Evidence of accessory muscle use with breathing
6. Shock (need for vasopressor therapy or MAP < 60 despite fluid administration)
7. Oliguric acute renal failure (urine output < 500 ml/day) unless already on
8. Patient already on NIPPV at the time of screening
9. Contraindications to NIPPV therapy:a) pH <7.30 or pCO2 >50 (if available) b)Fixed
upper airway obstruction c)Airway or facial trauma that would hinder the use of a
NIPPV mask d)Uncontrolled tachy or bradyarrhythmia or active myocardial ischemia
defined as either: Atrial fibrillation with rapid ventricular response (HR > 120 bpm),
Ventricular tachycardia or nonsustained ventricular tachycardia, Supraventricular
tachycardia, Third degree heart block , any heart rate less than 40 bpm e)Active
myocardial ischemia (acute ST elevation or non ST elevation MI f) GCS < 8 or
inadequate airway protective reflexes g)Undrained pneumothorax/pneumomediastinum h)
Copious secretions (> 20cc/hr sputum production or > 100 cc's hemoptysis/24 hrs, i)
Risk for gastric aspiration (ie; ileus, esophageal or bowel obstruction, active
vomiting) j )Recent esophageal, gastric or bowel surgery (within 3 weeks of study
enrollment) k) Inability to cooperate with NIPPV l) Refusal to receive NIPPV m)