Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT02464696

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

Led by M.D. Anderson Cancer Center · Updated on 2026-03-05

256

Participants Needed

1

Research Sites

573 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Partial pressure of arterial oxygen to fraction of inspired oxygen ratio (PaO2:FiO2) of 300 mmHg or less, or peripheral capillary oxygen saturation to FiO2 ratio (SaO2:FiO2) of 357 or less
  • Diagnosis of any malignancy
  • Chest X-ray or CT scan within 3 months before enrollment showing no active or metastatic lung or pleural cancer causing breathing problems
  • Expected survival of at least 6 months
Not Eligible

You will not qualify if you...

  • Presence of do not resuscitate (DNR) or do not intubate (DNI) orders at enrollment
  • Heart failure as the main cause of respiratory problems
  • Active lung or pleural cancer causing breathing problems
  • Acute exacerbation of chronic obstructive pulmonary disease as main cause of respiratory failure
  • Use of accessory muscles to breathe
  • Shock requiring vasopressors or low blood pressure despite fluids
  • Acute kidney failure with very low urine output unless on dialysis
  • Already using NIPPV at screening
  • Blood pH below 7.30 or high carbon dioxide levels (pCO2 > 50)
  • Fixed upper airway blockage
  • Facial or airway injury preventing NIPPV mask use
  • Uncontrolled abnormal heart rhythms or active heart attack
  • Glasgow Coma Scale below 8 or poor airway reflexes
  • Undrained pneumothorax or pneumomediastinum
  • Excessive sputum or significant bleeding from lungs
  • Risk of stomach contents entering lungs
  • Recent stomach or bowel surgery within 3 weeks
  • Unable or unwilling to use NIPPV
  • Respiratory arrest

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

M D Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

N

Nisha Rathi, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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