Using non-invasive ventilation to reduce intubation in cancer patients with respiratory failure

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

This study is testing if a breathing treatment called non-invasive ventilation can help cancer patients with respiratory failure avoid the need for a breathing tube compared to standard oxygen therapy.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 256 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: M.D. Anderson Cancer Center (other)
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT02464696 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of non-invasive positive pressure ventilation (NIPPV) compared to standard high flow oxygen therapy in reducing the need for intubation in patients with cancer and respiratory failure. Participants are randomly assigned to receive either NIPPV or high flow oxygen therapy for 28 days or until hospital discharge. The study aims to determine the percentage of patients who require intubation within 28 days of enrollment. Additionally, a subgroup of patients with idiopathic pulmonary syndrome will receive methylprednisolone alongside their assigned therapy. Follow-up will continue until day 100 post-enrollment.

Who should consider this trial

Good fit: Ideal candidates include patients with a diagnosed malignancy and respiratory failure who meet specific oxygenation criteria.

Not a fit: Patients with do not resuscitate (DNR) or do not intubate (DNI) orders, or those with significant intrathoracic malignancies causing respiratory insufficiency, may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the need for invasive intubation procedures in cancer patients experiencing respiratory failure.

How similar studies have performed: Other studies have shown promising results with non-invasive ventilation approaches in similar patient populations, suggesting potential for success in this trial.

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Copious secretions (\> 20 cc's of sputum production per hour or significant hemoptysis defined as \> 100 cc's of hemoptysis in a 24 hour period
* Risk for gastric aspiration (ie; ileus, esophageal or bowel obstruction, active vomiting)
* Recent esophageal, gastric or bowel surgery (within 3 weeks of study enrollment)
* Inability to cooperate with NIPPV
* Refusal to receive NIPPV
* Respiratory arrest

Where this trial is running

Houston, Texas

• M D Anderson Cancer Center — Houston, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: Nisha Rathi — M.D. Anderson Cancer Center
• Study coordinator: Nisha Rathi, MD

Conditions: Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm