Non-interventional Comparison of Sedatives on Weaning From Mechanical Ventilation in Intensive Care Patients

Study Overview
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Brief Summary
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The purpose of this study is to determine whether the use of different sedatives affect the weaning process from mechanical ventilation in intensive care patients.

Detailed Description
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Traditionally patients with ongoing mechanical ventilation have been sedated to assure absence of pain, anxiety and to provide comfort. Unfortunately this approach might have negative consequences such as prolonged time for mechanical ventilation, length of stay in the ICU and hospital. In this study, the investigators would like to investigate (in an exploratory way due to the non-interventional setup) whether weaning from mechanical ventilation will be affected by the choice of sedatives - including dexmedetomidine, midazolam and propofol. This study also aims at investigating how the choice of primary sedative will affect delirium/anxiety, need of other medications (sedatives, analgesics, anti-psychotics), quality of life after ICU and the presence of Post-Traumatic Stress Disorder. In addition, the investigators aim at receiving information from the caregivers on their ICU experience, as recent data imply that not only the ICU patient but also the caregiver suffer from PTSD after the ICU stay.

Official Title
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Non-interventional Comparison of Sedatives on Weaning From Mechanical Ventilation in Intensive Care Patients

Conditions
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Critical Illness

Intervention / Treatment
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* Other: SOC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Admitted to a general ICU ward ≥ 18years Intubated and mechanically ventilated for at least 24 hours Need of light to moderate sedation (corresponding to RASS 0 - (-3) or MAAS 2-3) Sedated with dexmedetomidine, midazolam and/or propofol Good knowledge in Swedish language Signed informed consent Exclusion criteria: Lack of fulfilling prescribed sedation regime Estimated high risk of death during the study period, according to investigator (roughly equal to estimated mortality rate (EMR) > 80% ) Tracheotomy Change in sedative drugs since the fit for weaning time point Use of other alpha-2 agonists (clonidine) during ICU stay Positive pregnancy test or currently lactating/ known pregnancy or lactation Participation in other study involving use of a pharmacologically active compound Patients with limitations in therapy Otherwise unable to fulfill the study, according to investigator's opinion

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dexmedetomidine<br>Here, patients to be included are those being sedated with dexmedetomidine as primary sedative. | Other: SOC<br>* Patient are given standard of care<br>|
| Propofol<br>Here, patients to be included are those being sedated with propofol as primary sedative. | Other: SOC<br>* Patient are given standard of care<br>|
| Midazolam<br>Here, patients to be included are those being sedated with midazolam as primary sedative | Other: SOC<br>* Patient are given standard of care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time point from when the patient is considered fit for weaning to the actual time point for extubation |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-point for patient being considered fit for extubation |  | 30 days | 
| Total time in mechanical ventilation |  | 30 days | 
| Extubation failure (re-intubation within 24 hours) |  | 24 hours | 
| Anxiety/delirium assessments | RASS/MAAS sedation scales and ICDSC/CAM-ICU delirium assessments methods are used, as appropriate | 30 days | 
| Length of ICU stay (actual time of discharge) |  | 30 days | 
| QoL (15D) |  | 2-4 months post-ICU discharge | 
| Post-Traumatic Stress Disorder assessment - PTSS14 questionnaire | This assessment will be offered to the ICU patients but also to their caregivers. | 2-4 months post-ICU discharge | 
| Total duration of sedation |  | 30 days | 
| Number of days using opioids |  | 30 days | 
| Number of days using antipsychotic/neuroleptic drugs |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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weaning, mechanical ventilation, dexmedetomidine, propofol, midazolam