Non-interventional Comparison of Sedatives on Weaning From Mechanical Ventilation in Intensive Care Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Critical Illness
- Sponsor
- Orion Corporation, Orion Pharma
- Enrollment
- 155
- Locations
- 3
- Primary Endpoint
- The time point from when the patient is considered "fit for weaning" to the actual time point for extubation
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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% )
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
The time point from when the patient is considered "fit for weaning" to the actual time point for extubation
Time Frame: 30 days
Secondary Outcomes
- Extubation failure (re-intubation within 24 hours)(24 hours)
- Length of ICU stay (actual time of discharge)(30 days)
- Number of days using opioids(30 days)
- Number of days using antipsychotic/neuroleptic drugs(30 days)
- Anxiety/delirium assessments(30 days)
- QoL (15D)(2-4 months post-ICU discharge)
- Post-Traumatic Stress Disorder assessment - PTSS14 questionnaire(2-4 months post-ICU discharge)
- Total duration of sedation(30 days)
- Time-point for patient being considered "fit for extubation"(30 days)
- Total time in mechanical ventilation(30 days)