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New treatment option for Hematopoietic and Lymphoid Cell Neoplasm
Official title Non-invasive Ventilation in Reducing the Need for Intubation in Patients With Cancer and Respiratory Failure
ClinicalTrials.gov ID: NCT02464696
What this study is testing
What is Methylprednisolone?
Methylprednisolone is an investigational medicine, given as an once-daily, being studied as a potential treatment for hematopoietic and lymphoid cell neoplasm.
Also referred to as Adlone, Caberdelta M.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Partial pressure of arterial oxygen (PaO2):fraction of inspired oxygen (FiO2) ratio =\< 300 mmHg OR a peripheral capillary oxygen saturation...
- 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...
- Probability of survival is at least 6 months
You likely can't join 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...
- 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)
See the full eligibility 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
- 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 \ 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.