Monitored Saturation Post-ICU | NCT02290236

Studies
Monitored Saturation Post-ICU

NCT02290236

Sponsor

Karolinska University Hospital

Status

Unknown status

Last Update Posted

Oct 12, 2016Estimated

Enrollment

500Estimated

Phase

Not provided

Conditions

Sleep Apnea, Obstructive
Respiratory Insufficiency

Interventions

Pulseoximetry

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2014

Primary Completion Date

Apr 2017Estimated

Completion Date

Jun 2017Estimated

First Submitted Date

Oct 6, 2014

First Submission Date that Met QC Criteria

Nov 10, 2014

First Posted Date

Nov 14, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 11, 2016

Last Update Posted Date

Oct 12, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Malin Jonsson Fagerlund, MD, PhD, Karolinska University HospitalPrincipal Investigator

Lead Sponsor

Karolinska University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pulseoximetry	Device	Peripheral saturation will be recorded continuously		Saturation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Oxygen desaturation index (ODI)	Measured by continuous pulseoximetry	Days

Secondary Outcomes

Measure	Description	Time Frame
STOP Bang screening questionnaire	At inclusion the STOP BANG screening questionnaire will be completed	Days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients that are discharged from the intensive care unit

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Malin Jonsson Fagerlund, MD, PhD	Karolinska University Hospital and Karolinska Institutet	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anesthesiology, Surgical Services and Intensive Care Medicine, Karolinska University Hospital, Solna		Stockholm		SE-17176	Sweden

Condition Browse Module

MeSH Terms

ID	Term
D020181	Sleep Apnea, Obstructive
D012131	Respiratory Insufficiency

Ancestor Terms

ID	Term
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided