NCT02464696 Non-invasive Ventilation in Reducing the Need for Intubation in Patients With Cancer and Respiratory Failure
| NCT ID | NCT02464696 |
| Status | Recruiting |
| Phase | — |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Hematopoietic and Lymphoid Cell Neoplasm |
| Study Type | INTERVENTIONAL |
| Enrollment | 256 participants |
| Start Date | 2015-10-06 |
| Primary Completion | 2026-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 256 participants in total. It began in 2015-10-06 with a primary completion date of 2026-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Nisha Rathi
PRINCIPAL INVESTIGATOR
M.D. Anderson Cancer Center
Frequently Asked Questions
Who can join the NCT02464696 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hematopoietic and Lymphoid Cell Neoplasm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02464696 currently recruiting?
Yes, NCT02464696 is actively recruiting participants. Contact the research team at NRathi@mdanderson.org for enrollment information.
Where is the NCT02464696 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT02464696 clinical trial?
NCT02464696 is sponsored by M.D. Anderson Cancer Center. The principal investigator is Nisha Rathi at M.D. Anderson Cancer Center. The trial plans to enroll 256 participants.