Intratracheal Suctioning and Oxygenation at Extubation | NCT03468036

Studies
Intratracheal Suctioning and Oxygenation at Extubation

NCT03468036

Sponsor

Jörg Schefold

Status

Completed

Last Update Posted

Jan 26, 2023Actual

Enrollment

250Actual

Phase

Not provided

Conditions

Extubation

Interventions

none, does not apply

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 7, 2019Actual

Primary Completion Date

Dec 1, 2022Actual

Completion Date

Dec 1, 2022Actual

First Submitted Date

Mar 9, 2018

First Submission Date that Met QC Criteria

Mar 9, 2018

First Posted Date

Mar 16, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 25, 2023

Last Update Posted Date

Jan 26, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

250Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
none, does not apply	Other	none: does not apply	Extubation with 100% O2 Extubation with 35% O2

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

ICU patients that undergo routine extubation

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joerg C Schefold, MD	Inselspital, University of Bern	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. of Intensive Care Medicine, University of Bern,		Bern		3010	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016638	Critical Illness
D012131	Respiratory Insufficiency

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D012120	Respiration Disorders

Browse Leaves

Not provided

Browse Branches

Not provided