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

Completed

• Conditions: Unplanned Extubation; Self Extubation
• Interventions: Other: NO INTERVENTION

• Registration Number: NCT04992117
• Lead Sponsor: Société Française d'Anesthésie et de Réanimation

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 available

Study Timeline

• Study Start: 2021-03-22
• Study First Submitted: 2021-07-28
• Study First Submitted QC: 2021-07-28
• Study First Posted: 2021-08-05
• Primary Completion: 2022-03-22
• Status Verified: 2022-07
• Study Completion: 2022-07-12
• Last Update Submitted: 2022-07-15
• Last Update Posted: 2022-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 633

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Unplanned-extubation in the ICU	NO INTERVENTION	Patients with unplanned extubation in the ICU

Primary Outcome Measures

Name	Time	Method
Quantitative description	During stay in the ICU	Quantitative description of unscheduled extubation episodes in intensive care unit

Secondary Outcome Measures

Name	Time	Method
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 ".

Trial Locations

Locations (1)

Hôpital La Pitié Salpêtrière- Département d'Anesthésie-Réanimation; 🇫🇷 Paris, France