INNOVATE: Intratracheal Suctioning and Oxygenation at Extubation

Sponsor

Jörg Schefold (Other)

Overall Status

Recruiting

CT.gov ID

NCT03468036

Collaborator

(none)

250

Enrollment

Location

20.8

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Extubation	Other: none, does not apply

Study Design

Study Type:

Observational

Anticipated Enrollment :

250 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Intratracheal Suctioning and Oxygenation at Extubation (INnovATE)

Actual Study Start Date :

Oct 7, 2019

Anticipated Primary Completion Date :

Jun 1, 2021

Anticipated Study Completion Date :

Jul 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Extubation with 100% O2 for further information please refer to study protocol	Other: none, does not apply none: does not apply
Extubation with 35% O2 for further information please refer to study protocol	Other: none, does not apply none: does not apply

Arm

Intervention/Treatment

Extubation with 100% O2

for further information please refer to study protocol

Other: none, does not apply

none: does not apply

Extubation with 35% O2

for further information please refer to study protocol

Other: none, does not apply

none: does not apply

Outcome Measures

Primary Outcome Measures

Difference in proportion of patients with need for ongoing ventilatory support [30 days max follow-up]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dept. of Intensive Care Medicine, University of Bern,	Bern		Switzerland	3010

Sponsors and Collaborators

Jörg Schefold

Investigators

Principal Investigator: Joerg C Schefold, MD, Inselspital, University of Bern

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jörg Schefold, Sponsor-investigator, University Hospital Inselspital, Berne

ClinicalTrials.gov Identifier:

NCT03468036

Other Study ID Numbers:

INNOVATE

First Posted:

Mar 16, 2018

Last Update Posted:

Mar 2, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Jörg Schefold, Sponsor-investigator, University Hospital Inselspital, Berne

Study Results

No Results Posted as of Mar 2, 2021