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New treatment option for Agitation,Psychomotor
Official title A Multicomponent Intervention Program to Prevent and Reduce ICU Agitation and Physical Restraint Use
ClinicalTrials.gov ID: NCT05783505
What this study is testing
- What it's testing
- Despite deleterious effects, physical restraints are still commonly used in (expected to become) agitated patients in Dutch ICUs (20-25%). This study aims to determine the effectiveness of a person-centered multicomponent intervention (MCI) program consisting of non-pharmacological interventions combined with goal directed light sedation using dexmedetomidine compared to the old standard of care including physical restraints in (expected to become) agitated adult ICU patients.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult ICU patients (aged ≥18) with an expected ICU stay of \>24 hours
- Patients who are (expected to become) agitated within the first 14 days of their ICU admission
You likely can't join if
- Contra indication for dexmedetomidine use (i.e., AV-block grade 2 or 3 unless a pacemaker is present, uncontrolled hypotension, acute cerebrovascular...
- Neurological patients with an (expected risk of) increased intracranial pressure;
- An intoxication as a result of drug abuse (e.g., ethanol, γ-Hydroxybutyrate, opioids, benzodiazepines);
- Support with Extracorporeal Membrane Oxygenation (ECMO);
- Difficult airway (e.g., a Cormack and Lehane laryngoscopy grade 4 view or a tumor causing airway obstruction);
- A high risk of physical aggression towards healthcare professionals;
See the full eligibility criteria
- Adult ICU patients (aged ≥18) with an expected ICU stay of \>24 hours
- Patients who are (expected to become) agitated within the first 14 days of their ICU admission
- Contra indication for dexmedetomidine use (i.e., AV-block grade 2 or 3 unless a pacemaker is present, uncontrolled hypotension, acute cerebrovascular condition or known/suspected hypersensitivity);
- Neurological patients with an (expected risk of) increased intracranial pressure;
- An intoxication as a result of drug abuse (e.g., ethanol, γ-Hydroxybutyrate, opioids, benzodiazepines);
- Support with Extracorporeal Membrane Oxygenation (ECMO);
- Difficult airway (e.g., a Cormack and Lehane laryngoscopy grade 4 view or a tumor causing airway obstruction);
- A high risk of physical aggression towards healthcare professionals;
- No consent for long term follow up in the MONITOR-IC study;
- Not able to read or understand the Dutch language and no relatives able to assist;
- Enrolment in other sedation studies.
The study team makes the final eligibility decision.
Where it's taking place
- Alkmaar, Netherlands
- Bergen op Zoom, Netherlands
- Breda, Netherlands
- Helmond, Netherlands
- Venlo, Netherlands
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Alkmaar, Netherlands; Bergen op Zoom, Netherlands; Breda, Netherlands; Helmond, Netherlands; Venlo, Netherlands. Enter your location above to see the nearest site and check your eligibility.
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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.