Compassionate Use of Hyperbaric Oxygen Therapy

The Compassionate Use of Hyperbaric Oxygen Therapy in the Treatment of COVID-19

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04386265

Enrollment

100

Registered

2020-05-13

Start date

2020-04-15

Completion date

2022-05-11

Last updated

2020-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Keywords

COVID-19, Mechanical Ventilation, Hyperbaric Oxygen Therapy, Patient Registry

Brief summary

This is an observational patient registry of COVID-19 patients treated with HBOT.

Detailed description

The retrospective analysis will focus on the reduction in need for mechanical ventilation in COVID-19 patients. The information will be gathered prospectively. Data will be collected from the patients' medical record, including medical notes and data recorded into the study database.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Inclusion criteria

* Adult patients with COVID-19. * The clinical decision to use HBOT is independent of the decision to participate in registry. * A signed and dated informed consent form for the off-label use of Hyperbaric Oxygen Therapy specific to the institution where treatment is rendered. * Subject is willing and able to comply with instructions and scheduled visits.

Exclusion criteria

* The Subject has other concurrent conditions that in the opinion of the Investigator may compromise patient safety. * The patient has an untreated pneumothorax.

Design outcomes

Primary

Measure	Time frame	Description
Gather information on patients treated with hyperbaric oxygen therapy	24 months	Collect information on the reduction in need for mechanical ventilation in COVID-19 patients.

Secondary

Measure	Time frame	Description
Gather information on adverse events	24 months	Follow adverse events associated with the treatment of COVID-19 related to HBOT

Countries

Poland, United States

Outcome results