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Critically Ill | Non-sedation Versus Sedation With a Daily Wake-up Trial in Critically Ill Patients Receiving Mechanical Ventilation - Effects on Physical Function

Critically Ill research study

What is the primary objective of this study?

Critically ill, ventilator-treated patients rapidly loose much of their muscle mass and strength. This can attribute to prolonged admission, prolonged mechanical ventilation, increased mortality and might have a negative impact on the physical function, degree of independence and quality of life. The pathophysiological background for the loss of muscle mass as well as possible effective treatment is still not well established. In the NONSEDA-trial we randomise critically ill patients to non-sedation or sedation with a daily wake-up trial during mechanical ventilation in the intensive care unit (ICU). It has never been assessed whether non-sedation reduces the loss of muscle mass and strength. Aim: To assess the effects of non-sedation versus sedation with a daily wake-up trial on physical function after discharge from ICU. Hypothesis: that non-sedation during ventilator-treatment will improve the physical function after ICU-discharge, compared with standard treatment of sedation with a daily wake-up.

Who is eligible to participate?

Inclusion Criteria: - Endotracheally intubated - Expected time on ventilator > 24 hours - Age ≥ 18 years - Informed consent Exclusion Criteria: - Severe head trauma where therapeutic coma is indicated - Therapeutic hypothermia where therapeutic coma is indicated - Status epilepticus where therapeutic coma is indicated - Patient has participated in the study before - Patient is transferred from another ICU with length of stay > 48 hours - Patient is comatose at admission - PaO2/FiO2 ≤ 9, if sedation is necessary for oxygenation

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Critically Ill

Muscular Atrophy

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:Non-sedation

Other:Sedation, control

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Non-sedationThe experimental group will not receive sedatives. Patients are thoroughly and repeatedly informed by the staff of where they are, what have happened, and what type of treatment they are going to receive. Participants will be awake and have a natural sleep rhythm. In case these patients develop and outward delirium, it is necessary to have a nurse or other caregiver at the bedside in order to calm the patient. Patients with delirium will be treated with haloperidol.

Sedation with daily wake-upThe control group will be sedated to Ramsay score 3-4. The first 48 hours the patients will be sedated with propofol, after 48 hours midazolam will be used. During daytime, the patient will be awakened as the intravenous infusion of sedatives will be discontinued. The patient will be considered to be awake when he/she can perform at least three of the following four tasks: Open the eyes to verbal commands. Follow the examiner's instructions with the eyes. Squeeze hands on request. Stick out the tongue on request. After a successful wake-up, the infusion of sedative will be resumed, starting on half of the pre-wake-up dose and adjusted to Ramsey score 3-4.

Study Status

Active, not recruiting

Start Date: January 2014

Completed Date: June 2019

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Physical function

Secondary Outcome: 6 minute walk

Study sponsors, principal investigator, and references

Principal Investigator: Helene K Nedergaard, MD

Lead Sponsor: Palle Toft

Collaborator: Sygehus Lillebaelt

More information:https://clinicaltrials.gov/show/NCT02034942

Strøm T, Martinussen T, Toft P. A protocol of no sedation for critically ill patients receiving mechanical ventilation: a randomised trial. Lancet. 2010 Feb 6;375(9713):475-80. doi: 10.1016/S0140-6736(09)62072-9. Epub 2010 Jan 29.

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