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

NCT02464696 | Recruiting DMC

• 2 other identifiers: 2015-0165NCI-2015-01514
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (1)

• Percent of patients who require intubation or meet criteria for intubation

  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.

  Up to 28 days from study inclusion

Secondary Outcomes (4)

• Time to intubation

  Up to 28 days

• Intensive care unit length of stay

  Up to 28 days

• Hospital length of stay

  Up to 28 days

• Change in partial pressure of arterial oxygen (PaO2):fraction of inspired oxygen (FiO2) ratio

  Baseline up to 28 days

Study Arms (2)

Arm A (NIPPV therapy)

EXPERIMENTAL

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.

Drug: Methylprednisolone; Device: Positive Air Pressure Device

Arm B (high flow oxygen therapy)

ACTIVE COMPARATOR

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.

Drug: Methylprednisolone; Procedure: Oxygen Therapy

Interventions

Methylprednisolone DRUG

IPS cohort only

Also known as: Adlone, Caberdelta M, DepMedalone, Depo Moderin, Depo-Nisolone, Duralone, Emmetipi, Esametone, Firmacort, Medlone 21, Medrate, Medrol, Medrol Veriderm, Medrone, Mega-Star, Meprolone, Methylprednisolonum, Metilbetasone Solubile, Metrocort, Metypresol, Metysolon, Predni-M-Tablinen, Prednilen, Radilem, Sieropresol, Solpredone, Summicort, Urbason, Veriderm Medrol, Wyacort

Arm A (NIPPV therapy); Arm B (high flow oxygen therapy)

Oxygen Therapy PROCEDURE

Receive high flow oxygen therapy

Also known as: supplemental oxygen therapy

Arm B (high flow oxygen therapy)

Positive Air Pressure Device DEVICE

Undergo NIPPV

Arm A (NIPPV therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Methylprednisolone; exifone; Medrol Veriderm; Oxygen

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Nisha Rathi

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nisha Rathi, MD

CONTACT

713-792-5040; NRathi@mdanderson.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2015
• First Posted: June 8, 2015
• Study Start: October 6, 2015
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

US (1)