Sleep in Critically Ill Patients on Mechanical Ventilation in ICU

Polysomnographic Sleep Characteristics Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02434341
• Other study ID #: s-20140207G
• Status: Completed
• Phase: N/A
• First received: April 30, 2015
• Last updated: April 27, 2016
• Start date: May 2015
• Est. completion date: April 2016

Study information

• Verified date: April 2016
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• wake non-sedated patients

• mechanical ventilation

Exclusion Criteria:

• age < 18 years

• pregnant

• Glasgow Coma Scale < 11

• sedated patients

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Polysomnographic Sleep Characteristics

Locations

Country	Name	City	State
Denmark	Intensive Care Unit, Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	polysomnographic sleep features		polysomnographic sleep assessment during up to 24 hours	No