BridgeMD
Opioid-Free Analgesia In Intensive Care Unit (OFICU)
EU CTIS ID: 2024-517770-14-00
What this study is testing
Compare daily remifentanil consumption, between the 24th hour and the 48th hour after randomization of ICU patients requiring at least 72 hours of mechanical ventilation, between patients following a standardized multimodal analgesia strategy without major opioids and patients following the conventional strategy
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patient hospitalized in ICU and requiring sedation-analgesia for mechanical ventilation
- Patient undergoing mechanical ventilation for more than 2 hours and less than 24 hours.
- Informed consent signed by the patient or his trusted person, legal representative, family member, curator or tutor, or emergency consent procedure
- Patient affiliated to the French Government Public Health Insurance
- Patient over 18 years old
You likely can't join if
- Patient already involved in a trial that might influence our primary endpoint
- Patient in exclusion-period determined by another trial or study
- Patient who is likely to be requiring less than 48 hours of mechanical ventilation
- Patient with contraindication or allergies to at least one of the following medication : paracetamol, nefopam, tramadol, ketamine, remifentanil
- Patient with hepatic insufficiency (defined as PT < 50%)
- Parturient or breast-feeding patient
See the full eligibility criteria
- Patient hospitalized in ICU and requiring sedation-analgesia for mechanical ventilation
- Patient undergoing mechanical ventilation for more than 2 hours and less than 24 hours.
- Informed consent signed by the patient or his trusted person, legal representative, family member, curator or tutor, or emergency consent procedure
- Patient affiliated to the French Government Public Health Insurance
- Patient over 18 years old
- Patient already involved in a trial that might influence our primary endpoint
- Patient in exclusion-period determined by another trial or study
- Patient who is likely to be requiring less than 48 hours of mechanical ventilation
- Patient with contraindication or allergies to at least one of the following medication : paracetamol, nefopam, tramadol, ketamine, remifentanil
- Patient with hepatic insufficiency (defined as PT < 50%)
- Parturient or breast-feeding patient
- Patient suffering from moderate to severe Acute Respiratory Distress Syndrome (ARDS), with decreased PaO2/FiO2 ratio under 150mmHg after respiratory optimization (courant volume 6mL/kg and PEEP > 5mbar)
- Patient requiring curare treatment
- Patient requiring ICU after undergoing major surgery (laparotomy or thoracotomy)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.