Unplanned-extubation in the ICU; Incidence, Characteristi... | NCT04992117

Studies
Unplanned-extubation in the ICU; Incidence, Characteristics and Prognosis. Success And Failure of Self-Extubation in the ICU

NCT04992117

Sponsor

Société Française d'Anesthésie et de Réanimation

Status

Completed

Last Update Posted

Jul 18, 2022Actual

Enrollment

633Actual

Phase

Not provided

Conditions

Unplanned Extubation
Self Extubation

Interventions

NO INTERVENTION

Countries

France

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

Jul 2022

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

Mar 22, 2021Actual

Primary Completion Date

Mar 22, 2022Actual

Completion Date

Jul 12, 2022Actual

First Submitted Date

Jul 28, 2021

First Submission Date that Met QC Criteria

Jul 28, 2021

First Posted Date

Aug 5, 2021Actual

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

Jul 15, 2022

Last Update Posted Date

Jul 18, 2022Actual

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

Our study consists of a national observational study assessing quantitatively (incidence) and qualitatively unscheduled extubation in intensive care unit. In addition, we will compare the outcome of patients with "success" or "failure" in the self-extubation subgroup.

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

633Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Unplanned-extubation in the ICU		Patients with unplanned extubation in the ICU	Other: NO INTERVENTION

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NO INTERVENTION	Other	NO INTERVENTION	Unplanned-extubation in the ICU

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Quantitative description	Quantitative description of unscheduled extubation episodes in intensive care unit	During stay in the ICU

Secondary Outcomes

Measure	Description	Time Frame
Qualitative description	Qualitative description of unscheduled extubation episodes in intensive care unit	During stay in the ICU
re-intubation	To assess factors associated with re-intubation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years or older
Mechanically ventilated with oral or nasotracheal intubation
Occurrence of an unscheduled extubation (auto-extubation or accidental extubation)
Extubation is defined as the removal of the orotracheal or nasotracheal tube with the impossibility of reinsertion of the same device.

Exclusion Criteria:

Opposition to the use of personal data
Pregnant women
Person under protective custody or guardianship

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

Patients with occurrence of an unscheduled extubation (auto-extubation or accidental extubation) in the ICU

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jean-Michel CONSTANTIN, MD	Hôpital La Pitié Salpêtrière - Paris	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital La Pitié Salpêtrière- Département d'Anesthésie-Réanimation		Paris			France

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