Sleep in Critically Ill Patients on Mechanical Ventilation in ICU

April 27, 2016 updated by: Yuliya Boyko, University of Southern Denmark

Sleep Investigation in 3 Homogeneous Groups of Wake Mechanically Ventilated Patients in ICU: 1st Group - Septical Patients; 2nd Group - COPD Patients; 3rd Group - Surgical Patients, in Order to Define Common Sleep Features Within the Groups

15 patients with sepsis, 15 patients with COPD and 15 surgical patients will undergo polysomnographic sleep monitoring up to 24 hours in order to define if there are common sleep features within the groups

Study Overview

Status

Completed

Conditions

Detailed Description

It is an observational study in order to define if there are common polysomnographic sleep features within the following three groups of wake critically ill patients on mechanical ventilation in ICU: the group of septical patients, the group of patients with chronic obstructive pulmonary disease in exacerbation and the group of surgical patients without sepsis.

15 patients will be included in each group. They will undergo polysomnographic sleep monitoring during up to 24 hours.

Polysomnograms will be studies then in order to find out if there are common sleep characteristics within the homogeneous patient groups of critically ill.

Study Type

Observational

Enrollment (Actual)

33

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odense, Denmark, 5000
        • Intensive Care Unit, Odense University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

wake

Description

Inclusion Criteria:

  • wake non-sedated patients
  • mechanical ventilation

Exclusion Criteria:

  • age < 18 years
  • pregnant
  • Glasgow Coma Scale < 11
  • sedated patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
septic patients
wake septic patients on mechanical ventilation
COPD patients
wake COPD patients on mechanical ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
polysomnographic sleep features
Time Frame: polysomnographic sleep assessment during up to 24 hours
polysomnographic sleep assessment during up to 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern Denmark

Investigators

  • Principal Investigator: Yuliya Boyko, MD, University of Southern Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

April 30, 2015

First Submitted That Met QC Criteria

April 30, 2015

First Posted (Estimate)

May 5, 2015

Study Record Updates

Last Update Posted (Estimate)

April 28, 2016

Last Update Submitted That Met QC Criteria

April 27, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • s-20140207G

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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