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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04115969
Other study ID # NIV-SUNDSVALL
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 4, 2019
Est. completion date December 31, 2019

Study information

Verified date June 2020
Source Västernorrland County Council, Sweden
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 92
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients treated with Non invasive ventilation

- Admitted to Sundsvalls ICU during 2018

Exclusion Criteria:

- Below 18 years age.

Study Design


Locations

Country Name City State
Sweden Västernorrland County Council / Sundsvall Hospital Sundsvall X

Sponsors (1)

Lead Sponsor Collaborator
Jakob Wallden

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patient characteristics Age, gender, comorbidities, indications for respiratory support, BMI, limitations of care. At the day of admission to the ICU - 1 day
Primary ICU-mortality Death occuring during ICU stay Patients will be followed during their ICU-stay - estimated to be 1 to 60 days.
Primary 30-day mortality Death within 30 days after ICU admission 30 days from admission to ICU
Secondary Factors associated with mortality Evaluate patient and ICU-factors and relation to mortality. 30 days from admission to ICU
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