NCT03468036

Brief Summary

Data analysis of routinely applied extubation procedures on the ICU: i.e. extubation with 100% O2 vs. 35% O2 with/without suctioning.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2019

Typical duration 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

March 9, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 16, 2018

Completed
1.6 years until next milestone

Study Start

First participant enrolled

October 7, 2019

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

January 26, 2023

Status Verified

January 1, 2023

Enrollment Period

3.2 years

First QC Date

March 9, 2018

Last Update Submit

January 25, 2023

Conditions

Extubation

Keywords

critical illnessICUextubationrespiratory failure

Outcome Measures

Primary Outcomes (1)

  • Difference in proportion of patients with need for ongoing ventilatory support

    30 days max follow-up

Study Arms (2)

Extubation with 100% O2

for further information please refer to study protocol

Other: none, does not apply

Extubation with 35% O2

for further information please refer to study protocol

Other: none, does not apply

Interventions

none, does not applyOTHER

none: does not apply

Extubation with 100% O2Extubation with 35% O2

Eligibility Criteria

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

ICU patients that undergo routine extubation

You may qualify if:

  • All adult (≥18 years) ICU patients with routine extubation on the ICU during the 2-month observational interval.

You may not qualify if:

  • Age \< 18 years
  • Patients on comfort therapy and/ or terminal extubation or accidental extubationtracheostomized patients
  • Patients with refusal to general consent or withdrawal of general consent (DLF and/or internal database)
  • Patients dying without next-of-kin available

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Intensive Care Medicine, University of Bern,

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Critical IllnessRespiratory Insufficiency

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration DisordersRespiratory Tract Diseases

Study Officials

  • Joerg C Schefold, MD

    Inselspital, University of Bern

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Sponsor-investigator

Study Record Dates

First Submitted

March 9, 2018

First Posted

March 16, 2018

Study Start

October 7, 2019

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

January 26, 2023

Record last verified: 2023-01

Locations

CH(1)