NCT02464696 · M.D. Anderson Cancer Center
Non-invasive Ventilation in Reducing the Need for Intubation in Patients With Cancer and Respiratory Failure
What this study is about
This randomly assigned 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Houston, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 5, 2026 · Source of record for eligibility and locations