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

Unplanned-extubation in the Intensive Care Unit; Incidence, Characteristics and Prognosis.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04992117

Acronym

SAFE-ICU

Enrollment

633

Registered

2021-08-05

Start date

2021-03-22

Completion date

2022-07-12

Last updated

2022-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Self Extubation, Unplanned Extubation

Keywords

Self extubation, Unplanned extubation, intensive care unit

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.

Interventions

OTHERNO INTERVENTION

NO INTERVENTION

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Qualitative description	During stay in the ICU	Qualitative description of unscheduled extubation episodes in intensive care unit
re-intubation	During stay in the ICU	To assess factors associated with re-intubation
Severe hemodynamic and respiratory events	One hour after extubation	To assess the incidence of severe hemodynamic and respiratory events of immediate onset
Length of stay in intensive care unit, the duration of mechanical ventilation and mortality	During stay in the ICU	Compare the length of stay in intensive care unit, the duration of mechanical ventilation as well as the mortality in intensive care of subjects with successful self-extubation (defined as no re-intubation on D7) compared to those in failure of self-extubation .

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026