NCT02464696

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 256 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Hematopoietic and Lymphoid Cell Neoplasm
• Malignant Solid Neoplasm

Interventions

Type	Name	Description
DRUG	Methylprednisolone	IPS cohort only
PROCEDURE	Oxygen Therapy	Receive high flow oxygen therapy
DEVICE	Positive Air Pressure Device	Undergo NIPPV

Timeline

• Start date: 2015-10-06
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2015-06-08
• Last updated: 2026-03-05

Locations

1 site across 1 country: United States