Is Reduced Hypoxia Through a Robot Intervention, Associated With Sensory and Emotional Descriptions of Dyspnea, Anxiety, Depression, Symptom Burden and Anxiolytics

NCT04375917 | Completed

• 1 other identifier: Ethic commitee H-17040114
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

COPD; Dyspnea; Anxiety; Depressive Symptoms; Hypoxia; Closed-Loop Communication

Outcome Measures

Primary Outcomes (1)

• Global dyspnea measured on scale A1 on multidimensional Dyspnea Profile (MDP)

  Multidimensional Dyspnea Profile (MDP) is validated for patients with COPD (40) The schedule is an instrument consisting of 11 rating scales that describe both the sensory and emotional dimension of dyspnea in a user-specified focus period.Patients perception of unpleasantness or discomfort in breathing sensations described as global dyspnea measured on an intensity scale from 0 (anchored by term; neutral) -10(anchored by term; unbearable )

  3 days

Secondary Outcomes (4)

• The emotional dimension of dyspnea

  3 days

• The sensory dimension of dyspnea

  3 days

• Current Dyspnea

  3 days

• Accumulated Dyspnea

  3 days

Other Outcomes (17)

• Respiratory symptom intensity

  3 days

• Anxiety symptoms

  3 days

• Depressive symptoms

  3 days

Study Arms (2)

Active

ACTIVE COMPARATOR

Usual care plus O2matic controlled oxygen therapy for a maximum of 3 days or until weaning from oxygen supplementation

Device: O2matic

control

NO INTERVENTION

Usual care plus manual controlled oxygen therapy by nursing staff. O2matic used in monitoring mode to measure SpO2 continuously

Interventions

O2matic DEVICE

O2matic is a closed-loop-system that controls oxygenadministration according to SpO2. The aim is to maintain SpO2 within a predefined target interval, E.G. 88-92% with the lowest possible supplementation of oxygen by nasal cannula

Active

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Copenhagen University Hospital, Hvidovre: lead

Study Sites (5)

Bispebjerg University Hospital

Copenhagen, 2400, Denmark

Location

Hvidovre University Hospital

Copenhagen, 2650, Denmark

Location

Herlev University Hospital

Copenhagen, 2730, Denmark

Location

Gentofte University Hospital

Copenhagen, 2900, Denmark

Location

Nordsjællands Hospital

Frederikssund, 3600, Denmark

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea; Anxiety Disorders; Depression; Hypoxia; Teach-Back Communication

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior; Communication

Study Officials

• charlotte Sandau Bech, MScHS

  Hvidovre University Hospital, Kettegaard alle

  PRINCIPAL INVESTIGATOR

• Thomas Jørgen Ringbæk, PhD, associated professor

  Hvidovre University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Nursing Specialist and PhD-fellow

Model Details: Open label randomized controlled parallel study

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 6, 2020
• Study Start: September 1, 2019
• Primary Completion: May 1, 2022
• Study Completion: October 1, 2022
• Last Updated: October 26, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (5)