Oxygen Control and Weaning by O2matic to Patients Admitted With an Exacerbation of COPD (O2MATIC-WEAN)

The aim of the study is to examine if automated oxygen delivery with O2matic allows for faster weaning from oxygen and better oxygen control than manually controlled oxygen therapy for patients admitted with an exacerbation of chronic obstructive pulmonary disease (COPD). Furthermore it will be tested if O2matic compared to manual control allows for faster discharge from hospital. Patients sense of security, anxiety and dyspnea will be evaluated by questionnaires.

Study Overview

• Status: Completed
• Conditions: Hypoxia; Respiratory Failure; Respiratory Insufficiency; COPD Exacerbation; Hypoxemia; Hyperoxia; Copd Exacerbation Acute
• Intervention / Treatment: Device: O2matic

Detailed Description

Closed-loop control of oxygen therapy is described in the literature used for preterm infants, trauma patients, medical emergency use and patients with COPD. For the latter, closed-loop therapy has been used for patients admitted to hospital with an exacerbation, for domiciliary oxygen use and during exercise. O2matic is a closed-loop system that is based on continuous and non-invasive measurement of pulse and oxygen-saturation (SpO2). The algorithm in O2matic controls oxygen delivery with the aim of keeping the SpO2 within the desired interval, which could be 88-92 % for COPD-patients in accordance with international guidelines on this topic. SpO2-interval can be set for the individual patients, as can the range of acceptable oxygen-flow. If SpO2 or oxygen-flow cannot be maintained within the desired intervals an alarm will sound.

All studies on closed-loop systems have shown that this method is better than manually control by nurse to maintain saturation within the desired interval. Furthermore, some studies have indicated that closed-loop has the possibility to reduce admission time and to reduce time spent with oxygen therapy, due to more efficient and fast withdrawal from oxygen supplementation.

In the present study O2matic will be tested versus manual control, for patients admitted with an exacerbation in COPD, and in need of supplemental oxygen. During the study the patients will either have oxygen controlled with O2matic or manually by nursing staff for 3 consecutive days. All patients will have continuous logging of pulse, oxygen-saturation and oxygen-flow with O2matic, but only in the O2matic active group, the algorithm will control oxygen-delivery.

The primary hypothesis is that O2matic compared to manual control allows for faster weaning from oxygen supplementation, and that more patients will be weaned from oxygen supplementation within a time frame of 3 days. Furthermore it will be tested if O2matic compared to manual control leads to faster achieved respiratory stability, allowing for hospital discharge. It will be tested if O2matic is better than manual control in maintaining oxygen-saturation within the desired interval and reducing time with unintended hypoxia and hyperoxia. Patients sense of security and feeling of anxiety and dyspnea will be evaluated by questionnaires.

No safety issues has been reported in the literature. O2matic is approved for clinical testing by The Danish Medicines Agency, The Ethics Committee in the Capital Region of Denmark and by the regional Data Protection Board. The study will be conducted according to Good Clinical Practice (GCP) standards with independent monitoring. All adverse events and serious adverse events will be monitored and serious adverse events will be reported to Danish Medicines Agency.

• Study Type: Interventional
• Enrollment (Actual): 157
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2400
    • Bispebjerg University Hospital
  • Frederikssund, Denmark, 3600
    • Nordsjællands Hospital
  • Hellerup, Denmark, 2900
    • Gentofte University Hospital
  • Herlev, Denmark, 2730
    • Herlev University Hospital
  • Hvidovre, Denmark, 2650
    • Hvidovre University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• COPD verified by Forced Expiratory Volume in 1. second (FEV1) divided by Forced Vital Capacity (FVC) < 0,70
• Admission due to exacerbation in COPD
• COPD exacerbation and pneumonia can be included
• Expected duration of admission > 48 hours
• Need for oxygen supplementation (SpO2 <= 88 % on room air)
• Cognitively 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 emboli)
• Asthma or other respiratory condition requiring higher SpO2 than normal for COPD
• Pregnancy
• Cognitive barriers for participation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: O2matic; Usual care plus O2matic controlled oxygen therapy for a maximum of 3 days or until weaning from oxygen supplementation	Device: O2matic; O2matic controls oxygen with the aim of maintaining SpO2 within a predefined target interval, e.g. 88-92 % with the lowest possible supplementation of oxygen by nasal cannula
No Intervention: Manual; Usual care plus manual controlled oxygen therapy by nursing staff. O2matic used in monitoring mode to measure SpO2 continuously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to weaning from oxygen supplementation	Time to weaning from oxygen supplementation in O2matic and manual arm (Patients will be followed for this outcome during the admission, up to 30 days)	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients weaned from oxygen supplementation after day 1	Fraction of patients weaned from oxygen supplementation after 1 day in O2matic and manual arm	1 day
Number of patients weaned from oxygen supplementation after day 3	Fraction of patients weaned from oxygen supplementation after 3 days in O2matic and manual arm	3 days
Time within SpO2 interval	Fraction of time within prescribed SpO2 interval in O2matic and manual arm	3 days
Time with severe hypoxemia	Fraction of time with SpO2 < 85 % in O2matic and manual arm	3 days
Time with minor hypoxemia	Fraction of time with SpO2 below target but not below 85 % in O2matic and manual arm	3 days
Time with hyperoxia	Fraction of time with SpO2 above target in O2matic and manual arm	3 days
Sensation of safety	Patients sensation of safety measured by Visual Analog Scale (VAS) score in O2matic and manual arm	3 days
Sensation of anxiety	Patients sensation of anxiety measured by Hospital Anxiety and Depression (HADS-A ) subscale in O2matic and manual arm	3 days
Sensation of dyspnea	Patients sensation of dyspnea measured by Multidimensional Dyspnea Profile (MDP) in O2matic and manual arm	3 days
Time to discharge	Time from admission to discharge from hospital	30 days

Collaborators and Investigators

• Sponsor: Hvidovre University Hospital
• Collaborators: Innovation Fund Denmark

Publications and helpful links

General Publications

• Lellouche F, L'her E. Automated oxygen flow titration to maintain constant oxygenation. Respir Care. 2012 Aug;57(8):1254-62. doi: 10.4187/respcare.01343. Epub 2012 Feb 17.
• Lellouche F, Bouchard PA, Roberge M, Simard S, L'Her E, Maltais F, Lacasse Y. Automated oxygen titration and weaning with FreeO2 in patients with acute exacerbation of COPD: a pilot randomized trial. Int J Chron Obstruct Pulmon Dis. 2016 Aug 24;11:1983-90. doi: 10.2147/COPD.S112820. eCollection 2016.
• Cirio S, Nava S. Pilot study of a new device to titrate oxygen flow in hypoxic patients on long-term oxygen therapy. Respir Care. 2011 Apr;56(4):429-34. doi: 10.4187/respcare.00983. Epub 2011 Jan 21.
• Lellouche F, L'Her E, Bouchard PA, Brouillard C, Maltais F. Automatic Oxygen Titration During Walking in Subjects With COPD: A Randomized Crossover Controlled Study. Respir Care. 2016 Nov;61(11):1456-1464. doi: 10.4187/respcare.04406. Epub 2016 Oct 18.
• Rice KL, Schmidt MF, Buan JS, Lebahn F, Schwarzock TK. AccuO2 oximetry-driven oxygen-conserving device versus fixed-dose oxygen devices in stable COPD patients. Respir Care. 2011 Dec;56(12):1901-5.
• L'Her E, Dias P, Gouillou M, Riou A, Souquiere L, Paleiron N, Archambault P, Bouchard PA, Lellouche F. Automatic versus manual oxygen administration in the emergency department. Eur Respir J. 2017 Jul 20;50(1):1602552. doi: 10.1183/13993003.02552-2016. Print 2017 Jul.
• Hansen EF, Hove JD, Bech CS, Jensen JS, Kallemose T, Vestbo J. Automated oxygen control with O2matic(R) during admission with exacerbation of COPD. Int J Chron Obstruct Pulmon Dis. 2018 Dec 14;13:3997-4003. doi: 10.2147/COPD.S183762. eCollection 2018.

Helpful Links

• Background and description of the O2matic device

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: September 1, 2018
• First Submitted That Met QC Criteria: September 4, 2018
• First Posted (Actual): September 7, 2018

Study Record Updates

• Last Update Posted (Actual): September 21, 2022
• Last Update Submitted That Met QC Criteria: September 19, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: closed-loop; oxygen treatment
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Signs and Symptoms, Respiratory; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Insufficiency; Hypoxia; Hyperoxia
• Other Study ID Numbers: O2MATIC-O2WEAN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No