No registrations found.
ID
Source
Brief title
Health condition
Intensive Care patients
Mechanical ventilation
Oxygenation targets
Sponsors and support
Intervention
Outcome measures
Primary outcome
All-cause mortality on day 28 after randomisation
Secondary outcome
The number of days alive and free from ventilation at day 28 after admission to the intensive care unit (ventilator-free days),
ICU-mortality and in-hospital mortality
ICU length of stay (LOS), hospital LOS
Organ failure (daily)
Reintubation rate
Cost of hospitalization
Ischemic events; myocardial, intestinal, cerebral or peripheral
Delirium
Blood stream infection and respiratory tract infection
Surgical site infection
Re-admission within 28 days
Long term follow-up:
Quality of life at 6 and 12 months after randomisation
Patient opinion of research and consent in the emergency setting at 6 months after randomisation
Background summary
Oxygen therapy is a widely used intervention in intensive care unit (ICU) patients. However, supraphysiological oxygenation may have harmful effects, especially during prolonged exposure. Several studies, including investigations from the Netherlands, have demonstrated a clear association between high arterial oxygen levels and increased mortality in ICU patients. Despite this accumulating evidence it remains unclear which arterial oxygenation targets to adher to for the highest survival. In this trial we aim to compare low normal (conservative) and high normal (conventional) oxygenation targets in Intensive Care patients.
Study objective
To compare a ventilation strategy that uses conservative targets (PaO2 55-80 mmHg (7.3-10.7 kPa)) with one that uses conventional oxygenation targets (PaO2 110-150 mmHg (14.7-20 kPa)) for arterial oxygenation. Primary endpoint is all-cause mortality at 28 days after ICU-admission.
Study design
Patients in participating intensive care units (ICU) will be screened for inclusion. Eligible patients will be randomised within 2 hours of start of mechanical ventilation. Informed consent will be obtained if possible prior to start of intervention. However, in the majority of the cases inclusion will take place in an emergency setting when the patient is incapacitated and in those cases deferred consent will be obtained as soon as possible, preferably within 72 hours after randomisation. Demographic data on screened patients regardless of meeting enrolment criteria will be recorded (registry: age, gender, admission type, organ failure and comorbidities).
At least one blood gas analyses per shift (three per 24 hours) will be required whilst mechanically ventilated. Daily evaluation registered in the eCRF will include ventilator mode and settings, delirium, and arterial blood gas and laboratory evaluation, whereby SOFA-scores will be calculated. When a study endpoint is reached transfusion of blood products, and events of bloodstream- and respiratory tract infection, surgical site infection, and ischemia will be evaluated and recorded.
Follow up will include hospital and 90-day mortality, which will be recorded. Furthermore, at 6 and 12 months patients will receive a quality of life and patient opinion about research and consent in the emergency setting questionnaire.
The investigator can decide to deviate from the study protocol for a subject for urgent medical reasons, such as ARDS with a PaO2/FiO2 ratio less than 150 mmHg. These patients will not be withdrawn from the study and will be analysed according to the intention-to-treat principle.
Intervention
The conservative oxygenation arm will be targeted at PaO2 55-80 mmHg (7.3-10.7 kPa) and/or SpO2 91-94% and the conventional oxygenation arm will be targeted at PaO2 between 110-150 mmHg (14.7-20 kPa) and/or SpO2 >96%.
Inclusion criteria
Age ≥ 18 years
Admission to an ICU participating in this study Need for intubation and mechanical ventilation
An expected mechanical ventilation time of 24 hours or longer
Inclusion within 2 hours after start of invasive ventilation in the study ICU or if previously intubated and ventilated within 2 hours after admission to the study ICU
Exclusion criteria
Readmitted to the intensive care unit and prior ICONIC inclusion
Invasive ventilation longer than 12 hours directly preceding admission
Participation in other interventional trials which could influence ICONIC intervention and/or endpoints
Suspected or confirmed pregnancy
Decision to withhold life-sustaining treatment at the time of inclusion
Acute respiratory distress syndrome (ARDS) with a PaO2/FiO2 ratio less than 150 mmHg
Acute decompensation of chronic obstructive pulmonary disease(COPD) and/or chronic hypoxaemia and/or use of home oxygen therapy
Underlying disease indication for hyperoxygenation (for example: carbon monoxide intoxication, decompression sickness, gas embolism)
Severe anaemia (Hb< 4.0 mmol/l) that is not rapidly reversible (e.g. if blood transfusions are not possible or not allowed for religious reasons)
Uncontrollable intracranial hypertension
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7185 |
| NTR-old | NTR7376 |
| CCMO | NL65236.058.18 |
| OMON | NL-OMON55692 |