Intratracheal Suctioning and Oxygenation at Extubation (INNOVATE)

Intratracheal Suctioning and Oxygenation at Extubation (INnovATE)

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

Study Overview

• Status: Completed
• Conditions: Extubation
• Intervention / Treatment: Other: none, does not apply

• Study Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Dept. of Intensive Care Medicine, University of Bern,

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

ICU patients that undergo routine extubation

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Difference in proportion of patients with need for ongoing ventilatory support	30 days max follow-up

Collaborators and Investigators

• Sponsor: Jörg Schefold
• Investigators: Principal Investigator: Joerg C Schefold, MD, Inselspital, University of Bern

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2019
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: March 9, 2018
• First Submitted That Met QC Criteria: March 9, 2018
• First Posted (Actual): March 16, 2018

Study Record Updates

• Last Update Posted (Estimate): January 26, 2023
• Last Update Submitted That Met QC Criteria: January 25, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: ICU; respiratory failure; critical illness; extubation
• Other Study ID Numbers: INNOVATE (Other Identifier: Inovio INO-4800 Vaccine Trial for Efficacy)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

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