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

Depression Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02040649
• Other study ID #: S-20130025b
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: March 2019

Study information

• Verified date: March 2019
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: March 2019
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Critical Illness
• Depression
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Other:
• Non-sedation
Patients are awake or have natural sleep during mechanical ventilation. Pain is treated with morphine iv.
• Control, sedation (propofol, midazolam)
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.

Locations

Country	Name	City	State
Denmark	Lillebaelt Hospital, Kolding, Intensive Care Unit	Kolding

Sponsors (4)

Lead Sponsor	Collaborator
Palle Toft	Kolding Sygehus, The Danish Council for Strategic Research, University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Strøm T, Stylsvig M, Toft P. Long-term psychological effects of a no-sedation protocol in critically ill patients. Crit Care. 2011;15(6):R293. doi: 10.1186/cc10586. Epub 2011 Dec 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTSD	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.	3 months after discharge from ICU
Secondary	Patient-reported quality of life	SF-36v2, mental component score for each group. The questionnaire is mailed to the participants, who complete it at home.	3 months after discharge from ICU
Secondary	Depression	Number of patients in each group diagnosed with depresion by the neuropsycologist, based on personal interview and Beck depression inventory score.	3 months after discharge from ICU
Secondary	Anxiety	Number of patients in each group diagnosed with anxiety by the neuropsycologist, based on personal interveiw and Beck anxiety inventory score.	3 months after discarge from ICU