BridgeMD
New treatment option for Sedation
Official title Inhaled Sedation in Critically Ill Patients
ClinicalTrials.gov ID: NCT07000526
What this study is testing
What is Isoflurane?
Isoflurane is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for sedation.
Also referred to as Inhaled sedation with Isoflurane.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The proposal of this study is to compare inhaled sedation with isoflurane administered via the Sedaconda ACD-S system with intravenous sedation with propofol. Patients will be randomized 1:1 to receive either inhaled sedation with isoflurane administered via the Sedaconda ACD device (Sedana Medical, Uppsala, Sweden) or intravenous propofol.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- \- Adult patients receiving mechanical ventilation, with an anticipated duration \>48 hours after randomization, and requiring deep sedation (target...
You likely can't join if
- Contraindication to isoflurane or propofol
- Patients with maternal ancestry from Venezuela, due to the potential presence of an mt-ND4 gene mutation associated with neurological injury after...
- Significant air leak, defined as a leak exceeding 30% of the delivered minute ventilation
- Allergy to isoflurane or propofol
- Cardiopulmonary arrest
- History of ventricular tachycardia or long QT syndrome
See the full eligibility criteria
- \- Adult patients receiving mechanical ventilation, with an anticipated duration \>48 hours after randomization, and requiring deep sedation (target RASS between -3 and -5).
- Contraindication to isoflurane or propofol
- Patients with maternal ancestry from Venezuela, due to the potential presence of an mt-ND4 gene mutation associated with neurological injury after exposure to certain volatile anaesthetic agents
- Significant air leak, defined as a leak exceeding 30% of the delivered minute ventilation
- Allergy to isoflurane or propofol
- Cardiopulmonary arrest
- History of ventricular tachycardia or long QT syndrome
- Tidal volume \ 50 mmHg at the time of randomization.
- Invasive mechanical ventilation for more than 48 hours at the time of randomization.
- Pregnancy
- Breast feeding
- Acute neurological condition
- Patients expected to require repeated surgical interventions during their ICU stay.
- ECMO
- ECCO2R
- Active humidification strictly required
- Neuromuscular disease or high spinal cord injury likely to prevent discontinuation of mechanical ventilation due to baseline condition
- Requirement for benzodiazepine use for a specific indication
- Burns
- Life expectancy less than 48 hours, or patients with such a level of severity that death during the ICU stay is considered highly likely.
- Any condition (e.g., blindness, deafness, dementia) or language barrier that prevents the administration of delirium or cognitive assessment scales.
- Lack of informed consent
The study team makes the final eligibility decision.
Where it's taking place
- Orihuela, Alicante, Spain
- Arrecife, Lanzarote-Canary Islands, Spain
- Galdakao, Vizcaya, Spain
- Albacete, Spain
- Badalona, Spain
- Barcelona, Spain
- Jaén, Spain
- Lleida, Spain
- Madrid, Spain
- Málaga, Spain
- Tarragona, Spain
- Toledo, Spain
- Valencia, Spain
- Valladolid, Spain
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 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Orihuela, Alicante, Spain; Arrecife, Lanzarote-Canary Islands, Spain; Galdakao, Vizcaya, Spain; Albacete, Spain; Badalona, Spain; Barcelona, Spain and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.