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

Conditions

• Hematopoietic and Lymphoid Cell Neoplasm
• Malignant Solid Neoplasm

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Oct 6, 2015

Status verified

Mar 2026

Primary completion

Oct 1, 2026

Completion

Oct 1, 2026

Study Design

Enrollment

256 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• Experimental: 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.
• Active Comparator: 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.

Primary Outcome Measure

Percent of patients who require intubation or meet criteria for intubation [ Time Frame: Up to 28 days from study inclusion ]

Central Contacts

• Nisha Rathi, MD
  713-792-5040
  [email protected]

Locations (1)

Find similar trials in Houston, TX

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