Non-sedation Versus Sedation With a Daily Wake-up Trial in Critically Ill Patients Receiving Mechanical Ventilation - Effects on Physical Function
Substudy of Non-Seda Trial (NCT01967680): Non-sedation Versus Sedation With a Daily Wake-up Trial in Critically Ill Patients Receiving Mechanical Ventilation - Effects on Physical Function. An Investigator-initiated, Randomised, Clinical, Parallel-group, Multinational, Superiority Trial
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Kolding, Danimarca, 6000
- Lillebaelt Hospital, Kolding
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Non-sedation
The 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. |
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Comparatore attivo: Sedation with daily wake-up
The 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:
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. |
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Physical function
Lasso di tempo: 3 months after ICU-discharge
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Co-primary outcome of: patient-reported quality of life, as measured by SF-36v2, physical component and degree of independence in activities of daily living, as measured by Barthel Index. Since this is a co-primary outcome, the type I error probability associated with the test of the null hypothesis should be less than 0,025. |
3 months after ICU-discharge
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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6 minute walk
Lasso di tempo: 3 months after ICU-discharge
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Walking distance in the 6 minute walk test at 3 months follow-up
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3 months after ICU-discharge
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Handgrip
Lasso di tempo: 3 months after ICU-discharge
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Handgrip-strength at 3 month follow-up
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3 months after ICU-discharge
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Thigh muscle size
Lasso di tempo: 3 months after ICU-discharge
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Muscle size, measured as cross section area of the rectus femoris muscle at 3 months follow-up
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3 months after ICU-discharge
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Biomechanical data
Lasso di tempo: 3 months after ICU-discharge
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Muscle strength, measured using biomechanical measurements - Maximal voluntary contraction (MVC), rate of force developement (RFD) and endurance at 25% of MVC at 3 months follow-up
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3 months after ICU-discharge
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Biomechanical data
Lasso di tempo: Within 24 hours of ICU-discharge
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Muscle strength - Maximal voluntary contraction (MVC), rate of force developement (RFD) and endurance at 25% of MVC at ICU-discharge.
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Within 24 hours of ICU-discharge
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Handgrip
Lasso di tempo: Within 24 hours of ICU-discharge
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Handgrip-strength at ekstubation and at ICU-discharge.
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Within 24 hours of ICU-discharge
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Thigh muscle size
Lasso di tempo: Within 24 hours of ICU-discharge
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Muscle size, measured as cross section area of the rectus femoris muscle at ekstubation and at ICU-discharge
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Within 24 hours of ICU-discharge
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Helene K Nedergaard, MD, Lillebaelt Hospital, Kolding
Pubblicazioni e link utili
Pubblicazioni generali
- Strom 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.
- Nedergaard HK, Jensen HI, Olsen HT, Strom T, Lauridsen JT, Sjogaard G, Toft P. Effect of non-sedation on physical function in survivors of critical illness - A substudy of the NONSEDA randomized trial. J Crit Care. 2021 Apr;62:58-64. doi: 10.1016/j.jcrc.2020.11.017. Epub 2020 Nov 24.
- Nedergaard HK, Jensen HI, Lauridsen JT, Sjogaard G, Toft P. Non-sedation versus sedation with a daily wake-up trial in critically ill patients receiving mechanical ventilation--effects on physical function: study protocol for a randomized controlled trial: a substudy of the NONSEDA trial. Trials. 2015 Jul 23;16:310. doi: 10.1186/s13063-015-0856-1.
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Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
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Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- S-20130025a
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