Not Yet RecruitingPhase 2ACTRN12616000587404

Breathe Easy Early Study (BEES): A randomised control study assessing the efficacy of early intervention with humidified high flow nasal cannula in the emergency department-Optimising outcomes in the Golden Hour of Respiratory failure.

The Breathe Easy Early Study: A randomised control study assessing the efficacy of early intervention with humidified high flow nasal cannula in the emergency department-Optimising outcomes in the Golden Hour of Respiratory failure.


Sponsor

Ipswich Hospital

Enrollment

268 participants

Start Date

May 30, 2016

Study Type

Interventional

Conditions

Summary

Tne Breathe Easy Early study is a randomised control trial to assess the efficacy of early intervention with humidified high flow nasal cannula in the emergency department- Optimising outcomes in the Golden Hour of respiaratory failure. Many patients present to the emergency department frequently feeling breathless. The cause of the breathlessness is varied and can be caused by problems with the heart, lungs, cancer or infection. On presentation to the emergency department, standard treatment of the breathless patient involves the application of oxygen via a face mask in addition to drug therapy and investigations including chest xrays and blood tests. If breathlessness gets worse, the patient may need breathing support in the way of non invasive or invasive breathing support which requires intensive nursing and medical care. Despite the benefit of these therapies they come with inherent risks to the patient. A breathing support device that provides noninvasive humidified high flow via a nasal cannula is one method of breathing support that is currently utilised safely in the critical care units of adult and paediatric hospitals. The high flow delivery provides small amounts of pressure to reduce the effort exerted by the patient while breathing in and to help splint the airways open. This pressure is not present during simple oxygen therapy. Additionally, the humidification of the high flow therapy helps maintain normal airway and lung function, by not drying out the airways. If we treat patients early with high flow therapy rather than using the standard facemask, we may be able to relieve symptoms of shortness of breath sooner and avoiding the worsening of breathing difficulties. Research Design and Methods: Ipswich Hospital Emergency Department will be the pilot site for this randomised controlled trial of early intervention with humidified high flow nasal cannula (HHFNC) vs. standard practice in the breathless patient. Patients that present to the Ipswich Hospital ED with dyspnoea will be identified at the point of triage and flagged as potential participants in the study. Participants will be randomised to receive study arm (HHFNC) or standard practice. Outcomes: The Primary outcome will be the proportion of patients who experience relief of dyspnoea. The secondary outcomes will include Time to relief of dyspnoea Time requiring respiratory supplementation Health care cost reduction with early initiation of supportive respiratory support


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria3

  • years and over
  • Symptomatic breathlessness- increased respiratory rate > 25 breaths per min and observed increased work of breathing.
  • Patients requiring oxygen supplementation to maintain Sp02 > 94% for acutely unwell patient OR 88% to 92% for those at risk of hypercapnic respiratory failure (in line with recruiting site hospital).

Exclusion Criteria8

  • Recent ENT surgery
  • Epistaxis/ nasal trauma/ sinus problems
  • Altered level of consciousness
  • Pregnancy
  • Non invasive ventilation at point of triage
  • Pneumothorax/chest trauma
  • History of trauma eg. post fall
  • Falling GCS or GCS <9

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Interventions

Humidified High Flow Nasal Cannula (HHFNC) is a therapy that utilises heated humidified blend of gases (i.e. Oxygen, Room Air) via large bore nasal cannula. Due to humidification, high flow therapy ca

Humidified High Flow Nasal Cannula (HHFNC) is a therapy that utilises heated humidified blend of gases (i.e. Oxygen, Room Air) via large bore nasal cannula. Due to humidification, high flow therapy can deliver flows of up to 60lt min and titrated fraction of inspired oxygen (Fi02). In this study, patients randomised to HHFNC will be commenced on 60lt/min and Fio2 titrated as per protocol. Oxygen concentration will depend on patients individual room air staurations after 10mins on 60lt. If patients Sp02 <94% (for non- COPD patients),then the FiO2 is tritated to achieve O2 saturations of >94%. If patients Spo2 < 88% (for known COPD patients), then Fio2 is tritated to achieve between 88%-92% O2 saturations. The duration of HHFNC therapy will depend on the individual patients clinical observations. Weaning off HHFNC therapy will occur when respiratory rate is <20bpm,SpO2 is within target ranges specified above in <50% FiO2 and improvement in the dyspnoea scale. Purpose made observation charts are utilised to monitor adherence and aid in data collection.


Locations(1)

QLD, Australia

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ACTRN12616000587404


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