Automated Oxygen Titration at Home in Patients With COPD on Home Oxygen

NCT05556187 | Completed DMC

• 1 other identifier: DaiLiHOT_2
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Twelwe patients with COPD and long term oxygen treatment (LTOT) will be included in the study. An automated home oxygen titrations (HOT) device will be attached to the patient´s home oxygen equipment. For 2x4 consequent days, the patients will be monitored and saturations, oxygen flow and physical activity level will be registered. In randomized order, the patients will use their usual fixed oxygen dose or automated oxygen titration during the first four days and then crossover. The monitoring consists of a wrist pulse oximeter (register pulse and saturation which is send to the HOT device) and a physical activity sensor attached to the patient's knee. At study start and after both of the four days the patients´dyspnea and QoL will be assessed. After the study period the patients will in an explorative design based on qualitative methodology be interviewed in order to explore the patients experiences with automated oxygen titration during daily activity and on dyspnea.

Conditions

COPD; Hypoxemia

Keywords

long term oxygen treatment; Automated oxygen titration; Physiotherapy; Activities of daily living

Outcome Measures

Primary Outcomes (1)

• Feasibility of using automated oxygen titration at home

  Automated oxygen titration during daily living will be considered feasible if 1. Data is successfully transmitted from the wrist pulse oximeter to O2matic HOT and further to the cloud solution (\<10 % data loss). 2. The patients are wearing the wrist pulse oximeter for more than 50 % of the daytime (08:00 - 20:00) 3. The time spent within acceptable SpO2-interval is statistically different between arms and in favor of automated oxygen titration with a difference of at least 10 percentage difference in time. 4. The patients are at least as active with O2matic HOT as with conventional oxygen therapy, measured by SENS activity monitor. 5. The patients are safe with no serious adverse events, including hypercapnia leading to unscheduled healthcare contacts.

  Immediately after the 2x4 days intervention

Secondary Outcomes (2)

• Change in CCQ-score

  Immediately after the intervention

• Physical activity

  Immediately after the intervention

Study Arms (2)

Usual fixed oxygen dose

NO INTERVENTION

* The oxygen dose will be as usual. * The patient's activity level will be monitored using SENS. * The patient will be asked to wear a wrist pulse oximeter to monitor pulse rate and saturation.

Automated oxygen titration

EXPERIMENTAL

* The O2matic equipment will be installed in the home of the patients. The SpO2-target will be set at 90-94% * The patient's activity level will be monitored using SENS. * The patient will be asked to wear a wrist pulse oximeter to monitor pulse rate and saturation and send the information to O2matic. O2matic will adjust the oxygen flow between 0.5-8 l/min according to the algorithm in the devise aiming at the SpO2-target interval. * The patients will use their usual portable oxygen devises for use when being active outdoor. They are allowed a higher oxygenflow if needed.

Other: Individualized automated oxygen titration

Interventions

Individualized automated oxygen titration OTHER

Automated oxygen titration based on the oxygen saturation during the entire day.

Automated oxygen titration

Eligibility Criteria

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

You may qualify if:

• Verified history of COPD with FEV1/FVC \< 0.70 and FEV1 \< 50 %
• Hypoxemic at rest (SpO2≤ 90 %) and fulfilment of general national criteria for LTOT
• Partial pressure of Oxygen (PaO2) (without oxygen supplement) ≤7.3 kPa in clinically stable and optimally treated condition
• Increase in PaO2 after oxygen supplementation (to 8.0-9.0 kPa) without decrease in arterial pH (\> 0.03 kPa)
• The oxygen is used at least 15 hours daily (optimally 24 hours daily)
• The treatment is handled by hospital departments with lung medical expertise.
• Able to walk at least 30 meters
• Age \>18, Cognitively able to participate in the study and willing to give informed consent

You may not qualify if:

• Pulmonary or cardiac condition other than COPD limiting physical performance
• Unstable heart condition or stenotic aortic valve disease
• A physical condition including paralysis, lower extremity pain, or back problem limiting physical performance
• Exacerbation in COPD treated with either antibiotics or prednisolone within the last 3 weeks
• The patients will also be excluded if they have a drop in pH to \< 7,31 (venous blood gas) on 8 litres per minute of oxygen flow OR an increase in PvCO2 on \> 1 kPa compared to usual fixed oxygen dose.

Sponsors & Collaborators

• Hvidovre University Hospital: lead
• Bispebjerg Hospital: collaborator

Study Sites (1)

Linette Marie Kofod

Hvidovre, 2650, Denmark

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Hypoxia

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Linette M Kofod, PT

  Hvidovre University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The two different oxygen doses at home is randomised after the initial assessment. It is not possible to blind the patients nor the investigator in this feasibility design.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist, Primary investigator

Model Details: The study will be conducted as a multicentre pilot randomized crossover feasibility trial.

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: September 27, 2022
• Study Start: January 10, 2023
• Primary Completion: December 29, 2023
• Study Completion: December 29, 2023
• Last Updated: January 31, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)