Outcome After Non-invasive Ventilation. | NCT04115969

Studies
Outcome After Non-invasive Ventilation.

NCT04115969

Sponsor

Jakob Wallden

Status

Completed

Last Update Posted

Jun 12, 2020Actual

Enrollment

92Actual

Phase

Not provided

Conditions

Respiratory Insufficiency

Interventions

Not provided

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

Jun 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 4, 2019Actual

Primary Completion Date

Dec 31, 2019Actual

Completion Date

Dec 31, 2019Actual

First Submitted Date

Oct 2, 2019

First Submission Date that Met QC Criteria

Oct 3, 2019

First Posted Date

Oct 4, 2019Actual

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

Jun 10, 2020

Last Update Posted Date

Jun 12, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jakob Wallden, Senior Lecturer, Consultant Anesthesiologist, MD, PhD., Västernorrland County Council, SwedenSponsor-Investigator

Lead Sponsor

Jakob WalldenOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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 study is an exploratory retrospective observational study with the aim to describe outcome fo the cohort of patients that receive non-invasive ventilation at an intensive care unit.

Main research questions are:

Characteristics of the cohort.
The course for the patients at the ICU.
ICU-mortality and 30-day mortality
Amount of patients with limitations of care.
Factors associated with mortality.

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

92Actual

Label	Type	Description	Intervention Names
Patients with non-invasive ventilation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patient characteristics	Age, gender, comorbidities, indications for respiratory support, BMI, limitations of care.	At the day of admission to the ICU - 1 day
ICU-mortality	Death occuring during ICU stay	Patients will be followed during their ICU-stay - estimated to be 1 to 60 days.
30-day mortality	Death within 30 days after ICU admission	30 days from admission to ICU

Secondary Outcomes

Measure	Description	Time Frame
Factors associated with mortality	Evaluate patient and ICU-factors and relation to mortality.	30 days from admission to ICU

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients treated with Non invasive ventilation
Admitted to Sundsvalls ICU during 2018

Exclusion Criteria:

Below 18 years age.

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 admitted to Sundsvalls intensive care unit treated with non-invasive ventilation.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Erik Svensk, MD	Västernorrland county council (Region Västernorrland)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Västernorrland County Council / Sundsvall Hospital		Sundsvall	X	851 86	Sweden

Condition Browse Module

MeSH Terms

ID	Term
D012131	Respiratory Insufficiency

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided