Hui, D., Morgado, M., Chisholm, G., Withers, L., Nguyen, Q., Finch, C., . . . Bruera, E. (2013). High-flow oxygen and bilevel positive airway pressure for persistent dyspnea in patients with advanced cancer: A phase II randomized trial. Journal of Pain and Symptom Management, 46, 463–473. 

DOI Link

Study Purpose

To examine changes in dyspnea through a randomized trial of high-flow oxygen (HFO) and bilevel positive airway pressure (BiPAP) in patients with cancer

Intervention Characteristics/Basic Study Process

Patients were randomized using a computer-generated randomization scheme in a 1:1 ratio to receive either two hours of HFO followed by a washout period and then two hours of BiPAP or two hours of BiPAP followed by a washout period followed by two hours of HFO. Data on dyspnea were collected every 10 minutes after the first intervention for as much as one hour. Patients participated in the second intervention if their dyspnea level was ≥ baseline dyspnea level minus one or  ≥ 3/10 after one hour.

Sample Characteristics

  • N = 30
  • AVERAGE AGE = 61 years (range = 29–79 years)
  • MALES: 47% (n = 14), FEMALES: 53% (n = 16)
  • KEY DISEASE CHARACTERISTICS: Lung 43% (n = 13), head and neck 3% (n = 1), genitourinary 3% (n = 1), gastrointestinal 10% (n = 3), breast 17% (n = 5), other 23% (n = 7); cancer stage metastatic 87% (n = 26) and local 13% (n = 4); causes of dyspnea were pulmonary parenchymal lesions 70% (n = 21), pleural effusions 50% (n = 15), lymphangitic carcinomatosis 7% (n = 2), and other noncancer causes; not already on home supplemental oxygen 70% (n = 21); majority of participants (93%) on supplemental oxygen at the time of enrollment with a median of 3 L per minute and an average oxygen saturation of 95% (SD = 4%). 
  • OTHER KEY SAMPLE CHARACTERISTICS: Inclusion criteria: average intensity of dyspnea at rest over the past week ≥ 3/10 on a numeric rating scale despite the use of supplemental oxygen, life expectancy of more than one week, and English-speaking; exclusion criteria: hemodynamic instability, acute respiratory distress with impending intubation, delirium (Memorial Delirium Assessment Scale > 13/30), Glasgow Coma Scale < 8/15, contraindications to BiPAP, or noncancer-related dyspnea with supplemental home oxygen before hospitalization

Setting

  • SITE: Single site  
  • SETTING TYPE: Inpatient  
  • LOCATION: MD Anderson Cancer Center

Phase of Care and Clinical Applications

  • PHASE OF CARE: End-of-life care
  • APPLICATIONS: Palliative care

Study Design

Randomized, open-label study with a parallel design and an optional second intervention

Measurement Instruments/Methods

  • Numeric Rating Scale (NRS), a measurement of dyspnea on a 0–10 scale
  • Modified Borg Scale (MBS), an assessment scale for dyspnea
  • Global symptom evaluation
  • Memorial Delirium Assessment Scale (MDAS)
  • Glasgow Coma Scale (GCS)

Results

This study found that dyspnea improved with both HFO and BiPAP in a comparison of pre- and post-treatment dyspnea. BiPAP use was associated with an average of a 3.2 dyspnea improvement on the NRS (p = 0.0004) and 1.5 on the MBS (p = 0.13). HFO was associated with an average improvement of 1.9 on the NRS (p = 0.02) and 2.1 on the MBS (p = 0.007). There were no significant differences in dyspnea relief between HFO and BiPAP on the NRS (P = 0.14) or the MBS (P = 0.47). BiPAP use also was associated with average improvements in NRS scores of 3.2 (P = 0.007) and 1.5 on the MBS (P = 0.13).
 
A statistically insignificant decrease in respiratory rate was identified with both devices. BiPAP use was associated with a decrease in heart rate (p = 0.02). HFO was associated with a significant decrease in systolic blood pressure (p = 0.02) and improvements in oxygen saturation (p = 0.003). No adverse effects were noted for either device. The majority of patients reported that HFO (10/13; 17%) and BiPAP (9/10) improved their dyspnea. 

Conclusions

HFO and BiPAP were found to alleviate dyspnea and improve physiologic parameters. The results of this study justify larger randomized, controlled studies to validate these findings. The authors of this study proposed that HFO and BiPAP be examined separately.

Limitations

  • Small sample (< 100)
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Other limitations/explanation: Multiple statistical comparisons were conducted. Baseline arterial blood gas and a measurement of oxygen saturation while on room air were not conducted.

Nursing Implications

Dyspnea is one of the most common symptoms for patients with cancer. This study shows that HFO and BiPAP may alleviate dyspnea. These devices are safe for patients to use. Larger randomized, controlled clinical trials are needed to confirm the findings of this study.