NCT03661086

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
157

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 7, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

September 21, 2022

Status Verified

September 1, 2022

Enrollment Period

3.6 years

First QC Date

September 1, 2018

Last Update Submit

September 19, 2022

Conditions

COPD ExacerbationHypoxiaHypoxemiaHyperoxiaRespiratory FailureRespiratory InsufficiencyCopd Exacerbation Acute

Keywords

closed-loopoxygen treatment

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Number of patients weaned from oxygen supplementation after day 1

    1 day

  • Number of patients weaned from oxygen supplementation after day 3

    3 days

  • Time within SpO2 interval

    3 days

  • Time with severe hypoxemia

    3 days

  • Time with minor hypoxemia

    3 days

  • +5 more secondary outcomes

Study Arms (2)

O2matic

ACTIVE COMPARATOR

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

Device: O2matic

Manual

NO INTERVENTION

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

Interventions

O2maticDEVICE

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

O2matic

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

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 emboli)
  • Asthma or other respiratory condition requiring higher SpO2 than normal for COPD
  • Pregnancy
  • Cognitive barriers for participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Bispebjerg University Hospital

Copenhagen, 2400, Denmark

Location

Nordsjællands Hospital

Frederikssund, 3600, Denmark

Location

Gentofte University Hospital

Hellerup, 2900, Denmark

Location

Herlev University Hospital

Herlev, 2730, Denmark

Location

Hvidovre University Hospital

Hvidovre, 2650, Denmark

Location

Related Publications (7)

  • 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.

    PMID: 22288082BACKGROUND

  • 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.

    PMID: 21255511BACKGROUND

  • 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.

    PMID: 22348812BACKGROUND

  • 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.

    PMID: 27601891BACKGROUND

  • 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.

    PMID: 27794080BACKGROUND

  • 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.

    PMID: 28729473BACKGROUND

  • 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.

    PMID: 30587955BACKGROUND

Related Links

MeSH Terms

Conditions

HypoxiaHyperoxiaRespiratory Insufficiency

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsRespiration DisordersRespiratory Tract Diseases

Study Officials

  • Jørgen Vestbo, DMSc

    Manchester University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Open label randomized controlled parallel study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Consultant

Study Record Dates

First Submitted

September 1, 2018

First Posted

September 7, 2018

Study Start

December 1, 2018

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

September 21, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

DK(5)