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

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.

Study Overview

• Status: Terminated
• Conditions: Critical Illness
• Intervention / Treatment: Other: SOC

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.

• Study Type: Observational
• Enrollment (Actual): 155

Contacts and Locations

Study Locations

• Sweden
  • Danderyd, Sweden, SE18288
    • Danderyds Hospital Anestesi- och intensivvårdskliniken
  • Stockholm, Sweden, SE11281
    • Capio S:t Goran Hospital, Anestesikliniken
  • Örebro, Sweden, SE70185
    • Örebro University Hospital, Anestesi- och intensivvårdskliniken

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult general intensive care patients Need of mechanical ventilation >24 hours Need of light to moderate sedation

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Dexmedetomidine; Here, patients to be included are those being sedated with dexmedetomidine as primary sedative.	Other: SOC; Patient are given standard of care
Propofol; Here, patients to be included are those being sedated with propofol as primary sedative.	Other: SOC; Patient are given standard of care
Midazolam; Here, patients to be included are those being sedated with midazolam as primary sedative	Other: SOC; Patient are given standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Orion Corporation, Orion Pharma
• Investigators: Principal Investigator: Carl-Johan Wickerts, MD, Danderyds Hospital, Danderyd, Sweden

Publications and helpful links

General Publications

• Nunes SL, Forsberg S, Blomqvist H, Berggren L, Sorberg M, Sarapohja T, Wickerts CJ. Effect of Sedation Regimen on Weaning from Mechanical Ventilation in the Intensive Care Unit. Clin Drug Investig. 2018 Jun;38(6):535-543. doi: 10.1007/s40261-018-0636-2.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2012
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: October 12, 2012
• First Submitted That Met QC Criteria: October 15, 2012
• First Posted (Estimate): October 16, 2012

Study Record Updates

• Last Update Posted (Actual): September 6, 2019
• Last Update Submitted That Met QC Criteria: September 4, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: mechanical ventilation; midazolam; dexmedetomidine; weaning; propofol
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 3005022; Dnr 2012/628-31/4 (Other Identifier: Ethical Review Board, Stockholm Region)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No