Non-interventional Comparison of Sedatives on Weaning From Mechanical Ventilation in Intensive Care Patients (NICEWEAN)
|ClinicalTrials.gov Identifier: NCT01707680|
Recruitment Status : Unknown
Verified November 2012 by Orion Corporation, Orion Pharma.
Recruitment status was: Recruiting
First Posted : October 16, 2012
Last Update Posted : November 2, 2012
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||250 participants|
|Official Title:||Non-interventional Comparison of Sedatives on Weaning From Mechanical Ventilation in Intensive Care Patients|
|Study Start Date :||June 2012|
|Estimated Primary Completion Date :||June 2013|
|Estimated Study Completion Date :||December 2013|
Here, patients to be included are those being sedated with dexmedetomidine as primary sedative.
Here, patients to be included are those being sedated with propofol as primary sedative.
Here, patients to be included are those being sedated with midazolam as primary sedative
- The time point from when the patient is considered "fit for weaning" to the actual time point for extubation [ Time Frame: 30 days ]
- Time-point for patient being considered "fit for extubation" [ Time Frame: 30 days ]
- Total time in mechanical ventilation [ Time Frame: 30 days ]
- Extubation failure (re-intubation within 24 hours) [ Time Frame: 24 hours ]
- Anxiety/delirium assessments [ Time Frame: 30 days ]RASS/MAAS sedation scales and ICDSC/CAM-ICU delirium assessments methods are used, as appropriate
- Length of ICU stay (actual time of discharge) [ Time Frame: 30 days ]
- QoL (15D) [ Time Frame: 2-4 months post-ICU discharge ]
- Post-Traumatic Stress Disorder assessment - PTSS14 questionnaire [ Time Frame: 2-4 months post-ICU discharge ]This assessment will be offered to the ICU patients but also to their caregivers.
- Total duration of sedation [ Time Frame: 30 days ]
- Number of days using opioids [ Time Frame: 30 days ]
- Number of days using antipsychotic/neuroleptic drugs [ Time Frame: 30 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01707680
|Contact: Barbro Holm, PhD||+46-86236438||Barbro.Holm@orionpharma.com|
|Contact: Hakan Klewstigh||+46-8-6236451||Hakan.Klewstigh@orionpharma.com|
|Danderyds Hospital Anestesi- och intensivvårdskliniken||Recruiting|
|Danderyd, Sweden, SE18288|
|Contact: Carl-Johan Wickerts, MD +4612357963 firstname.lastname@example.org|
|Principal Investigator: Carl-Johan Wickerts, MD PhD|
|Sub-Investigator: Silvia Lindqvist Nunes, MD PhD|
|Capio S:t Goran Hospital, Anestesikliniken||Recruiting|
|Stockholm, Sweden, SE11281|
|Contact: Hans Blomqvist, MD PhD +46762734060 email@example.com|
|Principal Investigator: Hans Blomqvist, MD PhD|
|Örebro University Hospital, Anestesi- och intensivvårdskliniken||Recruiting|
|Örebro, Sweden, SE70185|
|Contact: Lars Berggren, MD PhD +4619602 03 14 firstname.lastname@example.org|
|Principal Investigator: Lars Berggren, Md PhD|
|Principal Investigator:||Carl-Johan Wickerts, MD||Danderyds Hospital, Danderyd, Sweden|