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

Sponsor
SIZ Nursing (Other)
Overall Status
Completed
CT.gov ID
NCT04291911
Collaborator
(none)
300
1
4
2282.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    300 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Prospective Multicentre Observational Study on the Incidence of Hyperoxia in Non-intubated Patients in Intensive Care in Belgium Study OxSIZgen
    Actual Study Start Date :
    Sep 21, 2020
    Actual Primary Completion Date :
    Sep 25, 2020
    Actual Study Completion Date :
    Sep 25, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    INTENSIVE CARE UNITS

    Outcome Measures

    Primary Outcome Measures

    1. INCIDENCE HYPEROXIA [one week]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bruyneel Arnaud La Louvière Belgium

    Sponsors and Collaborators

    • SIZ Nursing

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Arnaud Bruyneel, President of SIZ Nursing, RN, CCRN, PhDc, SIZ Nursing
    ClinicalTrials.gov Identifier:
    NCT04291911
    Other Study ID Numbers:
    • SIZNursing
    First Posted:
    Mar 2, 2020
    Last Update Posted:
    Oct 8, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 8, 2020