Retrospective Multicentre Observational Study on the Incidence of Hyperoxia in Non-intubated Patients in Intensive Care in Belgium Study OxSIZgen (OxSIZgen)

October 5, 2020 updated by: Arnaud Bruyneel, SIZ Nursing

Prospective Multicentre Observational Study on the Incidence of Hyperoxia in Non-intubated Patients in Intensive Care in Belgium Study OxSIZgen

Oxygen is the most widely prescribed therapy in the ICU (intensive care unit) and can save lives in critical patients. While the deleterious effects of hypoxia are apparent and must be actively avoided, hyperoxia also has adverse effects. These include systemic, coronary and cerebral vasoconstriction; decreased coronary blood flow; pulmonary atelectasis and increased free radicals. Despite these deleterious effects, hyperoxia is common and frequent in the ICU (from 22% to 74%).

A recent meta-analysis published in "The Lancet" with more than 16,000 patients demonstrated an association between liberal oxygen therapy and mortality in critical patients. Other meta-analyses confirm its results with high quality data according to the authors.

A randomized controlled trial published in "The New England Journal of Medicine" comparing liberal versus conservative oxygen therapy showed no difference in mechanical ventilation days and mortality (The ICU-ROX, 2019). However, the difference in PaO2 between the two groups was very small and the PaO2 in the liberal group did not exceed 100 mmHg. In any case, conservative oxygen therapy is safe for critical patients.

The recommendations therefore recommend an oxygen saturation between 94-97% in critical patients and 88-92% in patients with COPD (Chronic Obstructive Pulmonary Disease) .

However, to our knowledge, no study has described the incidence of hyperoxia in non-intubated patients in the intensive care unit.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • La Louvière, Belgium
        • Bruyneel Arnaud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Oxygen patients in intensive care hospitals and no-intubated

Description

Inclusion Criteria:

  • Patient having oxygen
  • Not to be ventilated
  • Being over 18 years old

Exclusion Criteria:

  • Sickle cell disease patient
  • Patient with pneumo/hemothorax
  • Pregnant women, prisoners, denial of informed consent
  • Patients who are related to an investigator
  • Patients undergoing hyperbaric chamber therapy
  • Patients with CO
  • Patients on ECMO
  • Patients with paracoate poisoning...
  • Patients included in other interventional studies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
INTENSIVE CARE UNITS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
INCIDENCE HYPEROXIA
Time Frame: one week
one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SIZ Nursing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2020

Primary Completion (Actual)

September 25, 2020

Study Completion (Actual)

September 25, 2020

Study Registration Dates

First Submitted

February 27, 2020

First Submitted That Met QC Criteria

February 28, 2020

First Posted (Actual)

March 2, 2020

Study Record Updates

Last Update Posted (Actual)

October 8, 2020

Last Update Submitted That Met QC Criteria

October 5, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIZNursing

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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