NCT02290236

Brief Summary

The overall aim with this project is to describe the correlation between measured and charted saturation after intensive care and also describe the saturation-pattern in these patients. The investigators will also correlate post-ICU desaturations measured as oxygen denaturation index and complications to pre-ICU obstructive sleep apnea and the STOP BANG screening questionnaire.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 6, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 14, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

October 12, 2016

Status Verified

October 1, 2016

Enrollment Period

2.6 years

First QC Date

October 6, 2014

Last Update Submit

October 11, 2016

Conditions

Sleep Apnea, ObstructiveRespiratory Insufficiency

Outcome Measures

Primary Outcomes (1)

  • Oxygen desaturation index (ODI)

    Measured by continuous pulseoximetry

    Days

Secondary Outcomes (1)

  • STOP Bang screening questionnaire

    Days

Interventions

PulseoximetryDEVICE

Peripheral saturation will be recorded continuously

Also known as: Saturation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients that are discharged from the intensive care unit

You may qualify if:

  • \>18 years of age.
  • Admitted to the Central Intensive Care Unit (CIVA)
  • Signed informed conscent by the patient or a relative

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, Surgical Services and Intensive Care Medicine, Karolinska University Hospital, Solna

Stockholm, SE-17176, Sweden

Location

MeSH Terms

Conditions

Sleep Apnea, ObstructiveRespiratory Insufficiency

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Malin Jonsson Fagerlund, MD, PhD

    Karolinska University Hospital and Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

October 6, 2014

First Posted

November 14, 2014

Study Start

September 1, 2014

Primary Completion

April 1, 2017

Study Completion

June 1, 2017

Last Updated

October 12, 2016

Record last verified: 2016-10

Locations

SE(1)