NCT02040649

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
205

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 20, 2014

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

March 15, 2019

Status Verified

March 1, 2019

Enrollment Period

3.4 years

First QC Date

January 10, 2014

Last Update Submit

March 14, 2019

Conditions

Stress Disorders, Post-TraumaticDepressionAnxiety

Keywords

Critical careRespiration, artificial

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Patient-reported quality of life

    3 months after discharge from ICU

  • Depression

    3 months after discharge from ICU

  • Anxiety

    3 months after discarge from ICU

Study Arms (2)

Non-sedation

EXPERIMENTAL

Non-sedation supplemented with pain management during mechanical ventilation.

Other: Non-sedation

Sedation

ACTIVE COMPARATOR

Current gold standard: Sedation with a daily wake-up trial.

Other: Control, sedation (propofol, midazolam)

Interventions

Non-sedationOTHER

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

Non-sedation
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.

Sedation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Endotracheally intubated
  • Expected time on ventilator \> 24 hours
  • Age ≥ 18 years
  • Informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lillebaelt Hospital, Kolding, Intensive Care Unit

Kolding, 6000, Denmark

Location

Related Publications (1)

  • Strom 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.

    PMID: 22166673BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticDepressionAnxiety DisordersRespiratory Aspiration

Interventions

PropofolMidazolam

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBehavioral SymptomsBehaviorRespiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Helene Nedergaard, MD

    Lillebaelt Hospital, Kolding

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 10, 2014

First Posted

January 20, 2014

Study Start

January 1, 2014

Primary Completion

June 1, 2017

Study Completion

March 1, 2019

Last Updated

March 15, 2019

Record last verified: 2019-03

Locations

DK(1)