Automated Oxygen Delivery by O2matic to Patients Admitted With an Exacerbation in COPD

NCT03464695 | Completed DMC

• 1 other identifier: O2MATIC-COPD
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of the study is to examine if automated oxygen delivery with O2matic is better than manually controlled oxygen therapy for patients admitted to hospital with an exacerbation in Chronic Obstructive Pulmonary Disease (COPD). O2matic is a closed -loop system based on continuous non-invasive measurement of pulse and oxygen-saturation that is processed in an algorithm that controls the flow of oxygen to the patient. The primary hypothesis is that O2matic increases time within acceptable oxygen-saturation interval. Secondary hypotheses are that O2matic compared to manual control reduces time with severe hypoxia (SpO2 \< 85 %), hypoxi (SpO2 below intended interval) and hyperoxia (SpO2 above intended interval).

Conditions

COPD Exacerbation; Hypoxia; Hyperoxia; Respiratory Failure; Respiratory Insufficiency; Copd Exacerbation Acute

Keywords

closed-loop; oxygen treatment

Outcome Measures

Primary Outcomes (1)

• Time within SpO2-interval

  Fraction of time where SpO2 is kept within desired interval (e.g. 88-92 %) relative to time with SpO2-signal.

  4 hours

Secondary Outcomes (3)

• Time with severe hypoxia

  4 hours

• Time with hypoxia

  4 hours

• Time with hyperoxia

  4 hours

Study Arms (2)

O2matic

ACTIVE COMPARATOR

Oxygen administered by O2matic. Automatic adjustment based on continuous measurement of SpO2.

Device: O2matic

Manual

NO INTERVENTION

Oxygen administered by manual control based on nurse's intermittent measurement of SpO2.

Interventions

O2matic DEVICE

Continous measurement of SpO2 during an admission with COPD, and closed-loop control of oxygen-delivery to maintain SpO2 within a target interval.

O2matic

Eligibility Criteria

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

You may qualify if:

• COPD verified by FEV1/FVC \< 0,70
• Admission due to exacerbation in COPD
• COPD exacerbation and pneumonia can be included
• Duration of admission \> 48 hours
• 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 (except intermittent CPAP)
• Major co-morbidities (cancer, heart disease, thromboembolic disease, uncontrolled diabetes)
• Asthma or other respiratory condition requiring higher SpO2 than normal for COPD- patients
• Pregnancy
• Acute thromboembolic disease (\< 2 weeks)
• Cognitive barriers for participation

Sponsors & Collaborators

• Hvidovre University Hospital: lead
• Innovation Fund Denmark: collaborator

Study Sites (2)

Gentofte University Hospital

Hellerup, 2900, Denmark

Location

Hvidovre University Hospital

Hvidovre, 2650, Denmark

Location

Related Publications (7)

• Claure N, Bancalari E. Closed-loop control of inspired oxygen in premature infants. Semin Fetal Neonatal Med. 2015 Jun;20(3):198-204. doi: 10.1016/j.siny.2015.02.003. Epub 2015 Mar 12.

  PMID: 25773271 BACKGROUND

• Johannigman JA, Branson R, Lecroy D, Beck G. Autonomous control of inspired oxygen concentration during mechanical ventilation of the critically injured trauma patient. J Trauma. 2009 Feb;66(2):386-92. doi: 10.1097/TA.0b013e318197a4bb.

  PMID: 19204511 BACKGROUND

• 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: 28729473 BACKGROUND

• 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: 27601891 BACKGROUND

• 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: 27794080 BACKGROUND

• 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: 22288082 BACKGROUND

• 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: 30587955 RESULT

Related Links

• Open access to paper with results in Int J Chron Obstruct Pulmon Dis

MeSH Terms

Conditions

Hypoxia; Hyperoxia; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Jørgen Vestbo, DMSc

  Manchester University Hospital

  STUDY CHAIR

• Ejvind Frausing Hansen, MD

  Hvidovre University Hospital, Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: March 2, 2018
• First Posted: March 14, 2018
• Study Start: May 7, 2018
• Primary Completion: August 8, 2018
• Study Completion: August 8, 2018
• Last Updated: January 8, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)