Non-invasive Ventilation for Cancer Patients with Respiratory Failure

Overseen By Nisha Rathi, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Heart failure, COPD, Shock, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 28 days

256 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether a special breathing mask, known as non-invasive positive pressure ventilation (NIPPV), can help cancer patients with breathing problems avoid the need for a tube in their windpipe. Researchers aim to determine if this mask improves oxygen levels and reduces shortness of breath more effectively than the usual method, which involves a tube in the nose. Participants will either use the mask or continue with standard oxygen therapy for up to 28 days. Patients with cancer who struggle to breathe, but do not have cancer in their lungs or severe heart issues, may be suitable for this study. As an unphased trial, this study provides a unique opportunity to explore innovative solutions for breathing difficulties in cancer patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this non-invasive ventilation method is safe for cancer patients with respiratory failure?

Studies have shown that non-invasive positive pressure ventilation (NIPPV) is generally safe for patients. Research indicates that patients with chest tumors found NIPPV both practical and manageable. Another study noted fewer side effects, such as worsening breathing problems or coma, with NIPPV compared to other treatments. Additionally, NIPPV helps avoid complications associated with more invasive breathing support.

Overall, NIPPV is well-tolerated and has a good safety record for assisting those with breathing issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores two non-invasive ventilation methods for cancer patients facing respiratory failure. The trial compares high flow oxygen therapy, which delivers oxygen at higher rates to help patients breathe easier, with NIPPV (non-invasive positive pressure ventilation), which supports breathing by providing pressure to keep airways open, especially during sleep. Unlike the standard oxygen therapy, which is often continuous, NIPPV offers the flexibility of intermittent use. This approach might provide more personalized care and improve patient comfort. The trial aims to find out which method is more effective at reducing respiratory distress and improving overall patient outcomes.

What evidence suggests that non-invasive ventilation is effective for cancer patients with respiratory failure?

Research has shown that non-invasive positive pressure ventilation (NIPPV), which participants in this trial may receive, can assist individuals with breathing problems. Studies have found that NIPPV reduces the need for intubation, where a tube is placed in the windpipe to aid breathing. It also improves oxygen levels in the blood for those experiencing sudden breathing difficulties. Some evidence suggests that NIPPV can manage breathing issues in both short-term and long-term conditions. Although data specifically on cancer patients with breathing problems is limited, the overall benefits of NIPPV in similar situations appear promising. Another group in this trial will receive high-flow oxygen therapy, which has supported patients with respiratory failure by providing consistent oxygen levels. ^{1 2 6 7 8}

Who Is on the Research Team?

Nisha Rathi, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for cancer patients with respiratory failure who have a certain level of oxygen in their blood, expect to live at least 6 months, and don't have conditions like uncontrolled heart issues or recent surgeries that could complicate treatment. They shouldn't be at risk of vomiting into the lungs or already on non-invasive ventilation.

Inclusion Criteria

Have a diagnosed malignancy

Partial pressure of arterial oxygen (PaO2):fraction of inspired oxygen (FiO2) ratio =< 300 mmHg OR a peripheral capillary oxygen saturation (SaO2):FiO2 =< 357

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

Exclusion Criteria

You have a risk of stomach contents getting into your lungs, which can happen if you have a blockage in your esophagus or bowels, or if you are actively vomiting.

You have a blockage in your upper airway that doesn't go away.

Presence of do not resuscitate (DNR)/do not intubate (DNI) orders at study entry

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either intermittent NIPPV or high flow oxygen therapy for 28 days or until discharged from the hospital

28 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

72 days

What Are the Treatments Tested in This Trial?

Interventions

• Methylprednisolone
• Oxygen Therapy
• Positive Air Pressure Device

Trial Overview The study tests if non-invasive positive pressure ventilation (NIPPV), which uses a mask to deliver oxygen, is more effective than standard high-flow oxygen therapy through nasal prongs in improving blood oxygen levels and reducing the need for intubation in these patients.

How Is the Trial Designed?

Group I: Arm A (NIPPV therapy) Experimental Treatment 2 Interventions

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.

Group II: Arm B (high flow oxygen therapy) Active Control 2 Interventions

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.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

A meta-analysis of seven studies involving 245 stable hypercapnic COPD patients found that nocturnal non-invasive positive pressure ventilation (NIPPV) did not show consistent significant improvements in key health measures such as gas exchange, exercise tolerance, or quality of life.

While the mean increase in six-minute walking distance (6MWD) was 27.7 meters, this change was not statistically significant, indicating that the true effect of NIPPV on exercise capacity remains uncertain, especially given the small sample sizes of the studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nocturnal non-invasive positive pressure ventilation for stable chronic obstructive pulmonary disease. Struik, FM., Lacasse, Y., Goldstein, R., et al.[2022]

Noninvasive positive-pressure ventilation (NIPPV) is recommended as the first choice for treating acute respiratory failure in patients with hematologic malignancies or those recovering from bone marrow transplants, emphasizing the importance of early intervention.

NIPPV can be considered for select cancer patients with respiratory failure who have a do-not-intubate status, but it should not be used solely to prolong life in cases of terminal respiratory failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive positive-pressure ventilation in patients with malignancy. Marik, PE.[2017]

The study found that the maximum inspired oxygen fraction (FiO2) achievable with a CPAP system was 67.39%, particularly when oxygen was connected distally, indicating that CPAP can effectively deliver high levels of oxygen to patients in respiratory distress.

In contrast, non-invasive positive pressure ventilation (NIPPV) provided a higher minute volume compared to CPAP, but the FiO2 delivered was inversely related to the minute volume, suggesting that as breathing rate increases, the concentration of oxygen delivered decreases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inspired oxygen fraction achieved with a portable ventilator: determinant factors. Samolski, D., Antón, A., Güell, R., et al.[2013]

In a study of 100 patients with acute hypercapnic respiratory failure, 76% showed significant improvement in clinical parameters and arterial blood gas measurements after starting non-invasive positive pressure ventilation (NIPPV).

Improvement in heart rate, respiratory rate, pH, and PCO2 within the first hour of NIPPV treatment was a strong predictor of treatment success, while those who failed to respond often required intubation shortly after.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early predictors of success of non-invasive positive pressure ventilation in hypercapnic respiratory failure. Bhattacharyya, D., Prasad, B., Tampi, PS., et al.[2020]

Nasal intermittent positive pressure ventilation (NIPPV) is more effective than continuous positive airway pressure (CPAP) in preventing respiratory failure in preterm infants, based on meta-analyses of trials.

Using synchronized, ventilator-generated NIPPV not only reduces the need for additional ventilatory support but also lowers the incidence of bronchopulmonary dysplasia, although it does not affect mortality rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nasal Intermittent Positive Pressure Ventilation for Neonatal Respiratory Distress Syndrome. Rüegger, CM., Owen, LS., Davis, PG.[2022]

Non-invasive positive pressure ventilation (NIPPV) significantly improves patient-reported outcomes such as somnolence, fatigue, and sleep quality in individuals with chronic respiratory failure, particularly in conditions like ALS/MND and obesity hypoventilation syndrome (OHS).

Patients with ALS/MND also experience prolonged survival with NIPPV, while the effects on Duchenne muscular dystrophy (DMD) remain inconclusive, indicating that the benefits of NIPPV vary based on the underlying respiratory condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of non-invasive positive pressure ventilation for chronic respiratory failure. Hannan, LM., Dominelli, GS., Chen, YW., et al.[2018]

In a study of 1614 critically ill cancer patients, those who failed noninvasive positive pressure ventilation (NIPPV) had significantly higher ICU and hospital mortality rates (71.3% and 79.5%, respectively), indicating that NIPPV failure is a serious risk factor for poor outcomes.

Patients who successfully avoided intubation after NIPPV had better outcomes compared to those who required invasive mechanical ventilation, suggesting that NIPPV can be beneficial if it prevents the need for intubation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasivepositive pressure ventilation vsinvasive mechanical ventilation as first-line therapy for acute hypoxemic respiratory failure in cancer patients. Rathi, NK., Haque, SA., Nates, R., et al.[2020]

In a study involving 30 lung transplant patients, non-invasive mechanical ventilation (NIPPV) was successfully used to extubate 6 patients who were predicted to fail weaning, demonstrating its potential in postoperative care.

NIPPV improved oxygenation and pulmonary mechanics, leading to better respiratory rates and tidal volumes, while also reducing energy expenditure, indicating its efficacy in facilitating recovery after lung transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Noninvasive ventilation after lung transplantation]. Kilger, E., Briegel, J., Haller, M., et al.[2013]

In a study of 14 COPD patients experiencing severe exacerbations and respiratory acidosis, noninvasive intermittent positive pressure ventilation (NIPPV) significantly improved arterial blood gases in 10 patients, indicating its efficacy in treating this condition.

Despite the overall success of NIPPV, 4 patients did not respond and required intubation, highlighting that while NIPPV can be effective, it may not work for everyone in critical situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Noninvasive intermittent positive pressure ventilation in treatment of chronic respiratory disease exacerbation]. Bieleń, P., Burakowski, J., Sliwiński, P., et al.[2012]

In a study of 66 COPD patients over two years, adding noninvasive intermittent positive pressure ventilation (NIPPV) to pulmonary rehabilitation significantly improved health-related quality of life (HRQoL) and several other health metrics, despite not showing a significant difference in the Chronic Respiratory Questionnaire scores.

The addition of NIPPV also led to improvements in mood, dyspnea, gas exchange, exercise tolerance, and lung function, indicating that NIPPV can enhance the overall treatment outcomes for patients with chronic hypercapnic respiratory failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two-year home-based nocturnal noninvasive ventilation added to rehabilitation in chronic obstructive pulmonary disease patients: a randomized controlled trial. Duiverman, ML., Wempe, JB., Bladder, G., et al.[2022]

Citations

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Noninvasive Positive Pressure Ventilation for Acute ... The objective of this evidence-based analysis was to examine the effectiveness, safety, and cost-effectiveness of noninvasive positive pressure ventilation ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2405630824000612

Continuous and bilevel positive airway pressure may ... CPAP might reduce tumor motion by applying a constant positive airway pressure, resulting in increased lung volumes, more diaphragm flattening and consequently ...

3. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2760390

Association of Home Noninvasive Positive Pressure ... This meta-analysis of trials and observational studies evaluates the association of the use of home noninvasive positive pressure ...

4. nejm.org nejm.org/doi/full/10.1056/NEJMvcm1313336

Noninvasive Positive-Pressure Ventilation Now known as noninvasive positive-pressure ventilation (NPPV), it can be used to manage both acute and chronic respiratory failure.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2650588/

Noninvasive positive pressure ventilation in acute ... NIPPV is more effective in preventing endotracheal intubation in ARF due to COPD than other causes, and the etiology of ARF is an important predictor of NIPPV ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/23728654/

Non-invasive positive pressure ventilation (CPAP or bilevel ... We identified fewer adverse events with NPPV use (in particular progressive respiratory distress and neurological failure (coma)) when compared ...

7. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2788505

Effect of Noninvasive Respiratory Strategies on Intubation ... An initial strategy of CPAP significantly reduced the risk of tracheal intubation or mortality compared with conventional oxygen therapy.

8. jtd.amegroups.org jtd.amegroups.org/article/view/15052/html

Noninvasive ventilation during acute respiratory distress ... Noninvasive ventilation (NIV) is used to provide ventilator support with the aim of avoiding the complications of invasive mechanical ventilation.