Skip to main content
OpenTrials
Completed

NCT Number: NCT04291911

Retrospective 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bruyneel Arnaud

La Louvière, Belgium

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. INCIDENCE HYPEROXIA

    Time frame: one week

Sponsors and collaborators

Lead sponsor

SIZ Nursing

Other

Registry information

Official study title

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

Acronym: OxSIZgen

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 2, 2020
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.