Automated Oxygen Control by O2matic to Patients Admitted With Acute Hypoxemia

NCT04079465 | Completed DMC

• 1 other identifier: O2MATIC-ACUTE
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of this study is to examine if automated oxygen delivery with O2matic allows for faster weaning from oxygen supply and better oxygen control than manually controlled oxygen therapy for patients admitted to the emergency department with acute hypoxemia. Furthermore it will be tested if O2matic compared to manual control allows for earlier discharge.

Conditions

Hypoxemic Respiratory Failure; Hypoxia; Hypoxemia; Respiratory Failure; Respiratory Insufficiency

Keywords

closed-loop; oxygen treatment

Outcome Measures

Primary Outcomes (1)

• Probability of weaning from oxygen within 24 hours

  Fraction of patients weaned from oxygen supplementation within 24 hours

  24 hours

Secondary Outcomes (6)

• Probability of weaning from oxygen within 12 hours

  12 hours

• Duration of admission

  30 days

• Time within SpO2 target interval

  24 hours

• Time with minor hypoxemia

  24 hours

• Time with severe hypoxemia

  24 hours

Study Arms (2)

O2matic

ACTIVE COMPARATOR

Usual care plus O2matic controlled oxygen therapy for a maximum of 24 hours or until weaning from oxygen supplementation

Device: O2matic

Manual

NO INTERVENTION

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

Interventions

O2matic DEVICE

O2matic controls oxygen supply with a closed-loop feedback from a pulse oximeter. The aim is to maintain SpO2 within a predefined target interval according to guidelines for the specific condition causing hypoxemia, with the lowest possible supplementation of oxygen.

O2matic

Eligibility Criteria

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

You may qualify if:

• Admission with hypoxemic respiratory failure
• Age \>= 18 years
• Expected duration of admission \> 24 hours
• Need for oxygen supplementation to maintain SpO2 \>= 88 % (patients at risk of hypercapnia) or SpO2 \>= 94 % (other patients)
• 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)
• Patients with CO-poisoning or other condition with unreliable SpO2.
• Patients in need of oxygen supplementation at more than 10 liters/min
• Pregnancy
• Cognitive or language barriers for participation

Sponsors & Collaborators

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

Study Sites (2)

Amager Hospital

Copenhagen, 2300, Denmark

Location

Hvidovre Hospital

Hvidovre, 2650, Denmark

Location

Related Publications (4)

• O'Driscoll BR, Howard LS, Earis J, Mak V. British Thoracic Society Guideline for oxygen use in adults in healthcare and emergency settings. BMJ Open Respir Res. 2017 May 15;4(1):e000170. doi: 10.1136/bmjresp-2016-000170. eCollection 2017. No abstract available.

  PMID: 28883921 BACKGROUND

• Cornet AD, Kooter AJ, Peters MJ, Smulders YM. The potential harm of oxygen therapy in medical emergencies. Crit Care. 2013 Apr 18;17(2):313. doi: 10.1186/cc12554.

  PMID: 23635028 BACKGROUND

• Chu DK, Kim LH, Young PJ, Zamiri N, Almenawer SA, Jaeschke R, Szczeklik W, Schunemann HJ, Neary JD, Alhazzani W. Mortality and morbidity in acutely ill adults treated with liberal versus conservative oxygen therapy (IOTA): a systematic review and meta-analysis. Lancet. 2018 Apr 28;391(10131):1693-1705. doi: 10.1016/S0140-6736(18)30479-3. Epub 2018 Apr 26.

  PMID: 29726345 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 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency; Hypoxia

Condition Hierarchy (Ancestors)

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

Study Officials

• Ove Andersen, DMSc

  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: Senior Consultant

Model Details: Open label randomized controlled parallel study

Study Record Dates

• First Submitted: September 3, 2019
• First Posted: September 6, 2019
• Study Start: October 1, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)