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Non-invasive Ventilation for Cancer Patients with Breathing Problems

This study is looking at whether non-invasive positive pressure ventilation (NIPPV) can help cancer patients with respiratory failure (when lungs don't get enough oxygen to the blood) avoid needing a breathing tube (intubation). Patients with blood cancers or solid tumors who have breathing difficulties may be able to join. You would either receive NIPPV, which uses a mask to deliver oxygen, or standard high-flow oxygen therapy through a tube in your nose. Some patients with a specific lung condition called idiopathic pulmonary syndrome (IPS) will also receive methylprednisolone. The main goal is to see how many patients in each group need intubation within 28 days. The study's current status is unclear.

Study design
This is a randomized study with 256 planned participants. You would be assigned by chance to one of two treatment groups.
What's involved
You would receive either NIPPV or high-flow oxygen therapy for up to 28 days or until you leave the hospital. If you have IPS, you would also receive methylprednisolone for a period of time.
Compensation
Not stated in the trial record.
Follow-up
After your treatment, you would be followed for up to 100 days.

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NCT02464696

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

Recruiting
NAAges 18+InterventionalSupportive care
M.D. Anderson Cancer Center
~256 participants
Updated 2026-03-05 on ClinicalTrials.gov
What's tested:MethylprednisoloneOxygen TherapyPositive Air Pressure Device

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent of patients who require intubation or meet criteria for intubation
Measured over Up to 28 days from study inclusion

Conditions

Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm

Explore related trials

Hematopoietic and Lymphoid Cell NeoplasmMalignant Solid Neoplasm

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Nisha Rathi · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Nisha Rathi, MD
[email protected]
713-792-5040
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Percent of patients who require intubation or meet criteria for intubationUp to 28 days from study inclusion

    Fisher's exact test or a chi-squared test will be used to assess the association between two categorical variables. The intubation rate by 28 days and 95% confidence intervals will be estimated for each treatment arm. Logistic regression will be utilized to assess the effect of patient prognostic factors on the intubation rate by 28 days.