Presenting HYPERACT

Hypercapnia: A Randomized Clinical Trial with Dr. Jessica Whittle  

We invite you to learn about this recent multi-center, randomized controlled trial (RCT) which challenges the accepted standard treatment for patients with an acute exacerbation of moderate-severe COPD.* In this recorded presentation delivered in a Live setting, Dr. Jessica Whittle, one of the Principal Investigators, presents the study findings demonstrating that high velocity therapy is a reasonable alternative to Noninvasive Positive Pressure Ventilation (NiPPV) for spontaneously breathing, moderate to severe COPD patients.[1]

Learn more about the study results that suggest high velocity therapy may lead to reduced rates of intubation for patients unable to tolerate NiPPV  in this video… 

Dr. Whittle’s presentation includes the following HYPERACT study highlights: 

Inclusion Criteria 

  • Moderate to severe patient baseline hypercapnia, defined as a baseline pCO2 of 60 mmHg or higher 
  • Venous pH of 7.0 – 7.35 
  • Adults >18 years with a known or suspected diagnosis of COPD 
  • ED presentation with acute hypercapnic respiratory failure 

* More than 50% of the patients started with a pCO2 greater than 70 mmHg. 

Primary Outcome

This study compared NiPPV to high velocity therapy by measuring dyspnea on a modified Borg Scale (0 to 10) at baseline, 30 min, 60 min, and 240 min (4 hours) which determined high velocity therapy is a viable alternative to NiPPV for relieving dyspnea (Figure 1).[1]  

Figure 1

HYPERACT is the first multi-center RCT focused on patients with moderate to severe exacerbations of COPD, showing similar improvement in pH and pCO2 comparing high velocity therapy and NiPPV as demonstrated in the secondary outcomes (Figure 2) 

Secondary Outcomes

Figure 2 

Why consider an alternative therapy to the accepted standard mask-based treatment for COPD exacerbation? Mask complications may add time, cost, & impact patient outcomes[2]  

Possible complications from NiPPV:  

  • Time fitting and refitting the mask for patients to eat/drink, take medication, & speak 
  • Possible aspiration risk 
  • Gastric insufflation concerns 
  • Patients may require additional sedation 
  • High pressures can contribute to cardiovascular instability, requiring more medication 

Other Study Takeaways:

  • Patients on high velocity therapy reported statistically superior comfort ratings at every time point.  
  • 11% of patients on high velocity therapy were effectively treated in the ED and discharged home. No patients on NiPPV were discharged from the ED to home.  
  • 19% of NiPPV patients failed to tolerate therapy compared to 11% of high velocity therapy patients. 

Conclusion 

In the HYPERACT multicenter RCT, high velocity therapy was non-inferior to NiPPV in reducing dyspnea in ED patients presenting with acute exacerbation of COPD at 4 hours. The study also found similar results between high velocity therapy and NiPPV for PCO2 and pH concluding that high velocity therapy is a reasonable alternative for patients with acute exacerbation of COPD who present to the ED with hypercapnic respiratory distress. In appreciation of the similar outcomes and superior patient comfort findings, you can be the difference for your patients by considering high velocity therapy for hypercapnia. 

Dr. Whittle is the Chief Medical Officer and VP of Clinical Research at Vapotherm. She is a Professor and Vice Chair of Research for the Department of Emergency Medicine at the University of Tennessee – Chattanooga/Erlanger Health System.  She lectures both nationally and internationally on respiratory support and critical care and has been a featured guest on prominent EM podcasts, including EmRap and ACEP FrontLine. Dr. Whittle contributed to the ACEP Field Guide to COVID-19, which has been reproduced in 6 languages and over 120 countries.  She has authored 60+ peer-reviewed manuscripts and abstracts.

We’ve created a document to help Respiratory Therapists advocate to physicians the use of high velocity therapy for hypercapnic patients.

Download our new HYPERACT Document

Download

SOURCES:
1. Vapotherm Doc REPO-001430 HYPERACT Clinical Trial Summary and Report. 
2. Carron M et al, Complications of non-invasive ventilation techniques: a comprehensive qualitative review of randomized trials, British Journal of Anesthesia, 110 (6): 896–914 (2013). 
 
CAUTION: US Federal law restricts this device to sale by or on the order of a physician. Indications, contraindications, warnings, and instructions for use can be found in the product labelling supplied with each device or at https://vapotherm.com/resources/support/precision-flow-reference/.  For spontaneously breathing patients. High Velocity Therapy (HVT) does not provide total ventilatory requirements of the patient. It is not a ventilator. Decisions surrounding patient care depend on the physician’s professional judgment in consideration of all available information for the individual case, including escalation of care depending on patient condition. 
 
Study Limitations: 
Neither the participants, providers, nor assessors were blinded to the treatment arms, but all were blinded prior to allocation and enrollment  
Patients with respiratory distress due to mixed reasons may have been included, however, undifferentiated complaints are typical in ED setting 
Patients with respiratory distress due to mixed reasons may have been included, however, undifferentiated complaints are typical in ED setting 
Patients were able to provide verbal assent and not in imminent respiratory arrest. Caution should be exercised when extrapolating the results of this study to patients in extreme distress 
All patients received standard care; however, variability exists among clinicians regarding what constitutes standard of care  
Study utilized a subjective measure – degree of dyspnea – as primary outcome. However, it was augmented by quantitative pH and PCO2 values  
Study conducted during COVID-19 pandemic, acute phase