Automatic Oxygen Titration With O2matic® to Patients Admi... | NCT04565106

Studies
Automatic Oxygen Titration With O2matic® to Patients Admitted With COVID-19 and Hypoxemic Respiratory Failure

NCT04565106

Sponsor

Hvidovre University Hospital

Status

Completed

Last Update Posted

Sep 25, 2020Actual

Enrollment

16Actual

Phase

Not provided

Conditions

Covid19
Hypoxemic Respiratory Failure
Hypoxemia

Interventions

Closed-loop control of oxygen supplementation by O2matic

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 15, 2020Actual

Primary Completion Date

May 31, 2020Actual

Completion Date

May 31, 2020Actual

First Submitted Date

Sep 24, 2020

First Submission Date that Met QC Criteria

Sep 24, 2020

First Posted Date

Sep 25, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 24, 2020

Last Update Posted Date

Sep 25, 2020Actual

Name	Class
Innovation Fund Denmark	INDIV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Patients with coronavirus disease (COVID-19) and pneumonitis often have hypoxemic respiratory failure and a need of supplementary oxygen. Guidelines recommend controlled oxygen, for most patients with a recommended interval of SpO2 between 92 and 96 %. We aimed to determine if closed-loop control of oxygen was feasible in patients with COVID-19 and could maintain SpO2 in the specified interval.

Detailed Description

Patients were prospectively enrolled in an observational study on a medical ward dedicated to patients with COVID-19. Closed-loop controlled oxygen was delivered by O2matic® which can deliver 0-15 liters/min and adjusts flow every second based on 15 seconds averaging of SpO2 measured by pulse oximetry. Lung function parameters were measured at admission.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Closed-loop control of oxygen supplementation by O2matic	Device	Closed-loop control of oxygen supplementation to achieve a target SpO2 of 92 - 96 %

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time in SpO2 target	Time in SpO2 target of 92-96 %	1 week

Secondary Outcomes

Measure	Description	Time Frame
Time with SpO2 not more than 2 % outside target	Time with SpO2 not more than 2 % outside target	1 week
Time with SpO2 more than 2 % outside target	Time with SpO2 more than 2 % outside target

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Older than 18 years
Positive COVID-19 PCR analysis in pharyngeal swab or in tracheal secretion
Need oxygen supply to maintain SpO2 ≥ 92 %
Able to comply with continuous measurement of SpO2 by pulse oximetry.

Exclusion Criteria:

Need of oxygen supply > 10 liters/min at admission

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients admitted with COVID-19 pneumonitis and in need of oxygen supplementation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ove Andersen, PhD	Hvidovre University Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hvidovre University Hospital		Copenhagen		3550	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19
D012131	Respiratory Insufficiency
D000860	Hypoxia

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided