Non-invasive Ventilation in Reducing the Need for Intubation in Patients With Cancer and Respiratory Failure
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 366
Summary
- Conditions
- Hematopoietic and Lymphoid Cell Neoplasm
- Malignant Solid Neoplasm
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 follo...
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.
Tracking Information
- NCT #
- NCT02464696
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Nisha Rathi M.D. Anderson Cancer Center