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OpenTrials
Completed

NCT Number: NCT04992117

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

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.

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Key information

Conditions

Unplanned Extubation Self Extubation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital La Pitié Salpêtrière- Département d'Anesthésie-Réanimation

Paris, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

NO INTERVENTION

Primary outcomes

  1. Quantitative description

    Time frame: During stay in the ICU

    Quantitative description of unscheduled extubation episodes in intensive care unit

Secondary outcomes

  1. Qualitative description

    Time frame: During stay in the ICU

    Qualitative description of unscheduled extubation episodes in intensive care unit

  2. re-intubation

    Time frame: During stay in the ICU

    To assess factors associated with re-intubation

  3. Severe hemodynamic and respiratory events

    Time frame: One hour after extubation

    To assess the incidence of severe hemodynamic and respiratory events of immediate onset

  4. Length of stay in intensive care unit, the duration of mechanical ventilation and mortality

    Time frame: 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 ".

Sponsors and collaborators

Lead sponsor

Société Française d'Anesthésie et de Réanimation

Other

Registry information

Official study title

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

Acronym: SAFE-ICU

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 5, 2021
Registry last updated
Jul 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.