Outcome After Non-invasive Ventilation.

Outcome After Non-invasive Ventilation - an Observational Study at the Intensive Care Unit at Sundsvall Hospital.

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Insufficiency

• Study Type: Observational
• Enrollment (Actual): 92

Contacts and Locations

Study Locations

• Sweden
  • X
    • Sundsvall, X, Sweden, 851 86
      • Västernorrland County Council / Sundsvall Hospital

Participation Criteria

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

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Below 18 years age.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with non-invasive ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Jakob Wallden
• Investigators: Principal Investigator: Erik Svensk, MD, Västernorrland county council (Region Västernorrland)

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2019
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: October 2, 2019
• First Submitted That Met QC Criteria: October 3, 2019
• First Posted (Actual): October 4, 2019

Study Record Updates

• Last Update Posted (Actual): June 12, 2020
• Last Update Submitted That Met QC Criteria: June 10, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: critical care; non-invasive ventilation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: NIV-SUNDSVALL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No