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NCT Number: NCT02040649

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

Through many years, the standard care has been to use continuous sedation of critically ill patients during mechanical ventilation. However, preliminary randomised clinical trials indicate that it is beneficial to reduce the sedation level in these patients. The NONSEDA trial is an investigator-initiated, randomised, clinical, parallel-group, multinational, superiority trial designed to include 700 patients from at least six ICUs in Denmark, Norway and Sweden, comparing no sedation with sedation and a daily wake-up trial during mechanical ventilation. This is a substudy of the NONSEDA trial, concerning 250 patients included at trialsite Kolding, Denmark. The aim of the substudy is to assess the effects of no sedation on posttraumatic stress disorder after discharge from ICU.

Our hypothesis is that critically ill patients who are not sedated during mechanical ventilation will have less posttraumatic stress disorder after discharge.

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Key information

Conditions

Stress Disorders, Post-Traumatic Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lillebaelt Hospital, Kolding, Intensive Care Unit

Kolding, 6000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Patient does not speak Danish, swedish or norwegian at a reasonable level

Treatment and study plan

Non-sedation

Other

Patients are awake or have natural sleep during mechanical ventilation. Pain is treated with morphine iv.

Control, sedation (propofol, midazolam)

Other

Continuous iv-sedation (propofol first 48 hours, from then midazolam) to Ramsey 3-4 with a daily wake up attempt, where sedation is stopped until patient is awake.

Primary outcomes

  1. PTSD

    Time frame: 3 months after discharge from ICU

    Number of patients in each group diagnosed with PTSD by a neuropsycologist, based on an interview including posttraumatic stress disorder index and a general evaluation of the patient based on the ICD-10 criteria.

Secondary outcomes

  1. Patient-reported quality of life

    Time frame: 3 months after discharge from ICU

    SF-36v2, mental component score for each group. The questionnaire is mailed to the participants, who complete it at home.

  2. Depression

    Time frame: 3 months after discharge from ICU

    Number of patients in each group diagnosed with depresion by the neuropsycologist, based on personal interview and Beck depression inventory score.

  3. Anxiety

    Time frame: 3 months after discarge from ICU

    Number of patients in each group diagnosed with anxiety by the neuropsycologist, based on personal interveiw and Beck anxiety inventory score.

Sponsors and collaborators

Lead sponsor

Palle Toft

Other

Collaborators

  • Kolding Sygehus
  • The Danish Council for Strategic Research
  • University of Southern Denmark

Registry information

Official study title

Substudy of the NONSEDA-trial (NCT01967680): Non-sedation Versus Sedation With a Daily Wake-up Trial in Critically Ill Patients Receiving Me-chanical Ventilation - Effects on Posttraumatic Stress Disorder

Important dates

Study start
2014
Primary completion
2017
Study completion
2019
First posted
Jan 20, 2014
Registry last updated
Mar 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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