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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: NRathi@mdanderson.org
• Phone: 713-792-5040

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.