Is Reduced Hypoxia Through a Robot Intervention, Associated With Sensory and Emotional Descriptions of Dyspnea, Anxiety, Depression, Symptom Burden and Anxiolytics
Is Reduced Hypoxia Through a Robot Intervention, Associated With Sensory and Emotional Descriptions of Dyspnea, Anxiety, Depression, Symptom Burden and Anxiolytics
Chronic Obstructive Pulmonary Disease (COPD) is associated with high morbidity and mortality.
 The Danish Lung Association estimates that 320,000 Danes live with COPD, of which
 approximately 50,000 with severe COPD. In 2017, records showed that 23,979 admissions in
 Denmark were related to COPD; of these patients, about 20% were readmitted 2-30 days after
 discharge. The main symptom is dyspnea, which is often accompanied by anxiety. Primary
 treatment is; oxygen, bronchiolitis, prednisolone, morfin, NIV, and anxiolytics.

 Researchers at Hvidovre Hospital have developed an oxygen robot that continuously monitors
 the patient's SaO2 (oxygen saturation) and automatically administrates the oxygen depending
 on it. The preliminary results show that patients with robot-administrated oxygen were within
 defined SaO2 range in 85.7% of the time versus 46.6% when oxygen was nurse-administrated. The
 research was conducted as a multicentre Randomized Controlled Trial (RCT)focusing on
 physiological end-points.

 There is a lack of knowledge about the patient perspective of treatment with the oxygen
 robot.

 The purpose of this study is:

 1. To examine the association between robot-administered oxygen and patients' perception of
 dyspnoea, including the emotional response in the form of anxiety and depression

 The perspective is to be able to provide a holistic response to whether robot administered
 oxygen can be a better method of treating and alleviating dyspnoea.
Chronic Obstructive Pulmonary Disease (COPD) is a high prevalence disease and is associated
 with high morbidity and mortality worldwide. In 2017, there were 23.979 COPD related
 admissions in Denmark, approximately 10% died during hospitalization, while 20% of survivors
 were readmitted between day 2-30 after discharge. Patients with COPD often experience long
 disease trajectories characterized by a substantial burden of symptoms, impaired functional
 status, multiple admissions and thereby reduced quality of life. The cardinal symptom dyspnea
 is associated with hypoxemia, anxiety and depression. Evidence shows that depression is a
 significant risk factor for disabling dyspnea, while risk of anxiety increases with the
 severity of Dyspnea.

 The prevalence of anxiety and depression is indicated to lie between 10%-55% and 10%-86% in
 patients hospitalized with COPD in exacerbation . Patients with COPD have an 85% increased
 risk of developing anxiety compared to a matching control group without COPD. The prevalence
 of anxiety is 10 times higher among patients with COPD than in the background population and
 are strongly associated with the risk of hospitalization, long admissions, readmissions and
 death. Anxiety and depression are often treated with benzodiazepines which have a respiratory
 suppressive effect. Consumption of benzodiazepines increases disease progression, and studies
 have shown that 31.7% of patients with COPD have a benzodiazepine consumption and that 9%
 initiate a new benzodiazepine ordination in conjunction with an exacerbation. The evidence
 that oxygen prevents disease progression and mortality is consistent, but there is a lack of
 knowledge about whether oxygen, can reduce the intensity of dyspnea in patients with COPD. In
 the acute phase of an exacerbation the oxygen flow is titrated to achieve a SaO2 between
 88-92%. Keeping patients with COPD within the given SaO2 range is essential because too low
 SaO2 can induce tissue damage, heart overload and difficulty concentrating, while
 hyperoxaemia can inhibit respiration and increase the risk of hypercapnia, acidosis and the
 need for ventilatory support in the form of Non-invasive Ventilation (NIV). In clinical
 practice, oxygen flow is administered and titrated, via aggregates, by nurses based on point
 observations, with the risk of patients being outside optimal SaO2 range, between
 observations. To improve practice, a group of researchers at Hvidovre Hospital has developed
 an oxygen robot, called O2matic, which continuously monitors the patient's SaO2 and
 automatically administrates oxygenflow according to it. O2Matic has been tested in a
 randomized controlled trial (RCT) in 2018. Patients admitted with an exacerbation of COPD and
 hypoxemia (SaO2 ≤ 88%) was included (N = 19). The design was crossover and patients were
 allocated to either 4 hours of manual oxygen administration via nurse followed by 4 hours of
 oxygen administration via O2Matic, or vice versa. The study showed that patients with O2matic
 controlled oxygen administration were within defined SaO2 range in 85.7% of the time versus
 46,6% of the time when the oxygen was controlled and administrated by a nurse . These results
 are in consensus with a former Canadian study testing an alternative oxygen robot (FreeO2).
 The two RCT Studies provide evidence to investigate robot-administered oxygen therapy for
 inpatient patients with exacerbation of COPD in a larger multicenter Randomized Controlled
 Trail.

 Dyspnea is defined as; "A subjective experience of breathing discomfort that consist of
 qualitatively distinct sensations that vary in intensity". The experience of dyspnea is a
 product of a physical perception based on signals from the body to the brain followed by the
 cognitive processing of these into an emotional experience. Dyspnea is thus an emotional and
 sensational experience based on perceptual afferent feedback from various respiratory
 receptors. Up to 16 possible mechanisms are involved in the process . Given the above,
 dyspnea is a complex symptom, mainly induced by the body's attempts to obtain homeostasis,
 when subjected to hypoxemia. Despite this dyspnea is not the same as hypoxemia, as it has not
 been clearly demonstrated that reduced hypoxemia, by oxygen therapy also reduces Dyspnea.
 However, there are indications in the literature that oxygen therapy can reduce the
 experience of dyspnea. A significant barrier to the use of oxygen therapy as an intervention
 on fragmentary dyspnea in patients with COPD is the risk of hypercapnia and acidosis. Oxygen
 therapy administrated according to saturation in a closedloop-feedback-system by a robot,
 could potentially be an intervention to relieve fragmentary dyspnea in patients with COPD.
 International guidelines show that dyspnea is not treated consistently nor effectively in the
 advanced stages of the disease.

 Opioids are one of the most widely used agents in the treatments of dyspnea. Opioids
 suppress' respiration and treatment should be balanced to avoid respiratory depression.
 Guidelines points out the importance of identifying and graduate the intensity of dyspnea in
 clinical practice, without indicating any superior instruments to achieve this. Majority of
 instruments developed, describe dyspnea in relation to activity. As COPD progress, dyspnea
 intensifies and patients will become more inactive and often live a sedentary life. Few
 questionnaires measure the sensory and emotional domains of dyspnea independently of activity
 and diagnose. One is the multidimensional Dyspnoea profile (MDP) that has recently been
 translated into Danish. In order to reduce symptom burden, length of hospital stay, number of
 readmissions and mortality, new knowledge and more effective methods for treating and
 alleviating dyspnea and the associated anxiety and depression are needed in patients with
 COPD. Studies investigating the effect of oxygen therapy, including time with and degree of
 hypoxemia, in hypoxemic patients experiencing dyspnea, anxiety or depression during
 hospitalization with acute exacerbation, could not be identified. Because O2matic provides a
 new and unique opportunity to reduce and illuminate time with hypoxemia during
 hospitalization and patient's subjective experience of the sensory and emotional aspects of
 dyspnea can be reported on a validated questionnaire via MDP, researchers now have an option
 to investigate if a robot intervention, that reduces time with hypoxemia, has an effect on
 dyspnea in patients admitted with a exacerbation of COPD. Furthermore, investigators want to
 examine whether this intervention alters the consumption of opioids and benzodiazepines.

 Primary hypothesis. Reduced time with hypoxia, via active differentiated oxygen supply
 determined by visible monitored saturation, affects the sensory and emotional response to
 dyspnea, anxiety, depression and consumption of medication.

 Primary objective:

 To investigate whether there is an association between time with hypoxemia and dyspnea,
 described by the Sensory Question (SQ) scale and A2 scale of MDP, in patients admitted with
 an exacerbation of COPD and a need for oxygen therapy Secondary hypothesis 1 The intensity of
 dyspnea, anxiety, depression and respiratory symptom burden is dependent on time with and
 degree of hypoxemia

 Secondary objective 1:

 To investigate whether there is an association between time with-and degree of hypoxemia and
 respectively dyspnea, anxiety, depression and symptom burden Secondary hypothesis 2 Reduced
 time with-and degree of hypoxemia reduces consumption of anxiolytics expressed in Mg

 Secondary objective 2:

 To investigate whether there is an association between time with-and degree of hypoxemia and
 anxiolytics represented as Benzodiazepines, morphine and "Oramorph" drops
Inclusion Criteria:

 -  • COPD veryfied by Forced Expiratory Volume in 1 sec (Fev1) divided by forced Vital
 Capacity (FVC)< 0,70

 -  Admission due to exercabation in COPD

 -  COPD exacerbation and pneumonia can be included

 -  Expeted duration of admission >48 hours

 -  Need for oxygen supplementation (SpO2<= 88% in room air) Cognitive able to
 participate in the study

 -  Willing to participate and give informed consent

 Exclusion Criteria:

 -  • Need or anticipated need for mechanical ventilation ( Intermittent continuous
 Positive Airway Pressure (CPAP) is allowed)

 -  Major comorbidities causing hypoxemia (cancer, heart disease, pulmonary embolia)

 -  Asthma or other respiratory conditions requiring higher SpO2 than normal for COPD
 Pregnancy

 -  Cognitive barrierers for participation