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Implementation of lower oxygenation targets to improve outcome in ICU patients.

Implementation of lower oxygenation targets to improve outcome in ICU patients

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON27410
Enrollment
10000
Registered
2012-05-07
Start date
2012-07-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

High inspiratory oxygen concentrations and high arterial oxygen pressures (PaO2) are independently associated with higher mortality in ICU patients. Although (inter)national guidelines advocate low (physiological) oxygenation targets, ICU-patients in the Netherlands achieve much higher PaO2 values.

Interventions

The study phases: 1. Retrospective: Baseline measurement over 12-months period. They include in-hospital mortality, ICU-mortality, number of days alive and without artificial ventilation at 28 days a
2. First implementation phase. This phase will consist of providing a written guideline with clear recommendations how to adapt oxygen administration and ventilator settings depending on arterial bloo
3. Introduction decision-support. The decision-support will be based on exactly the same targets as the guideline from phase 2 and will work in the active, critiquing mode, meaning that it will give d

Sponsors

Leiden University Medical Center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All ICU patients admitted during the studyperiod at 3 ICUs, with subgroup analysis in all patients on mechanical ventilation.

Exclusion criteria

Exclusion criteria: Patients on extracorporeal membrane oxygenation (ECMO).

Design outcomes

Primary

MeasureTime frame
Primary End-points will include an analysis of the process of implementation, specifically the mean proportion (per patient) of PaO2 measurements within target range (primary endpoint), mean PaO2 and FiO2, and mean proportion of PaO2 measurements > 16 kPa (hyperoxia). Additional endpoint is the subjective judgement and appreciation of the guideline and the oxygenation targets by physicians and nurses.

Secondary

MeasureTime frame
Secondary End-points, Outcome: Hospital mortality, ICU-mortality and days alive and without mechanical ventilation at 28 days after ICU admission. Outcome endpoints will be studied in all ICU patients and in a subgroup of patients that had mechanical ventilation at any time during ICU-stay.

Contacts

Public ContactEvert Jonge, de

PO-box 9600

e.dejonge@lumc.nl+31 (0)71 5265018

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)