NCT04115969

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

October 2, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 4, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

October 4, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

June 12, 2020

Status Verified

June 1, 2020

Enrollment Period

3 months

First QC Date

October 2, 2019

Last Update Submit

June 10, 2020

Conditions

Respiratory Insufficiency

Keywords

non-invasive ventilationcritical care

Outcome Measures

Primary Outcomes (3)

  • 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 (1)

  • Factors associated with mortality

    30 days from admission to ICU

Study Arms (1)

Patients with non-invasive ventilation

Eligibility Criteria

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

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

You may qualify if:

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

You may not qualify if:

  • Below 18 years age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Västernorrland County Council / Sundsvall Hospital

Sundsvall, X, 851 86, Sweden

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Erik Svensk, MD

    Västernorrland county council (Region Västernorrland)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Senior Lecturer, Consultant Anesthesiologist, MD, PhD.

Study Record Dates

First Submitted

October 2, 2019

First Posted

October 4, 2019

Study Start

October 4, 2019

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

June 12, 2020

Record last verified: 2020-06

Locations

SE(1)