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

Terminated

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.

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Propofol	SOC	Here, patients to be included are those being sedated with propofol as primary sedative.
Midazolam	SOC	Here, patients to be included are those being sedated with midazolam as primary sedative
Dexmedetomidine	SOC	Here, patients to be included are those being sedated with dexmedetomidine as primary sedative.

Primary Outcome Measures

Name	Time	Method
The time point from when the patient is considered "fit for weaning" to the actual time point for extubation	30 days

Secondary Outcome Measures

Name	Time	Method
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	RASS/MAAS sedation scales and ICDSC/CAM-ICU delirium assessments methods are used, as appropriate
QoL (15D)	2-4 months post-ICU discharge
Post-Traumatic Stress Disorder assessment - PTSS14 questionnaire	2-4 months post-ICU discharge	This assessment will be offered to the ICU patients but also to their caregivers.
Total duration of sedation	30 days
Time-point for patient being considered "fit for extubation"	30 days
Total time in mechanical ventilation	30 days

Locations (3): Capio S:t Goran Hospital, Anestesikliniken
🇸🇪
Stockholm, Sweden
Örebro University Hospital, Anestesi- och intensivvårdskliniken
🇸🇪
Örebro, Sweden
Danderyds Hospital Anestesi- och intensivvårdskliniken
🇸🇪
Danderyd, Sweden

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