Arterial oxygenation targets in mechanically ventilated patients in the intensive care unit, a randomized controlled triali

Completed

• Conditions: aandoeningen met een Intensive Care indicatie; Critical Care; Mechanical Ventilation

• Registration Number: NL-OMON55692
• Lead Sponsor: Intensive Care

Brief Summary

Trial is onging in other countries

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-12-22
• Results First Posted: 2023-10-24
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 653

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 Intensive Care Unit
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 chronic
hypoxaemia
Use of home oxygen therapy
Severe not rapidly reversible low cardiac output shock (for example: cardiac
index <=2 L/min/m2)
Documented severe pulmonary hypertension
VA-ECMO
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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>All-cause mortality at 28 days after randomization.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The number of ventilator-free days and alive at day 28, defined as the number<br /><br>of calendar days from day 1 to day 28; the patient is alive and breathes<br /><br>without assistance of the mechanical ventilator. Ventilator-free days are<br /><br>according to the definitions by the Dutch National Intensive Care Evaluation<br /><br>(NICE) registry.<br /><br>ICU length of stay (LOS)<br /><br>Hospital LOS<br /><br>ICU mortality<br /><br>Hospital mortality<br /><br>90-day mortality<br /><br>Reintubation rate<br /><br>Transfusion of blood products, including packed red blood cells, plasma and<br /><br>platelet concentrates<br /><br>Delirium<br /><br>Ischaemic events (cardiac, neurological and peripheral)<br /><br>Blood stream and respiratory tract infection<br /><br>Organ failure<br /><br>Readmission to Intensive Care within 28 days<br /><br>Quality of life<br /><br>Patient experience consent procedure</p><br>