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

July 15, 2022 updated by: Société Française d'Anesthésie et de Réanimation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

633

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France
        • Hôpital La Pitié Salpêtrière- Département d'Anesthésie-Réanimation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Unplanned-extubation in the ICU
Patients with unplanned extubation in the ICU
Other: NO INTERVENTION
NO INTERVENTION

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualitative description
Time Frame: During stay in the ICU
Qualitative description of unscheduled extubation episodes in intensive care unit
During stay in the ICU
re-intubation
Time Frame: During stay in the ICU
To assess factors associated with re-intubation
During stay in the ICU
Severe hemodynamic and respiratory events
Time Frame: One hour after extubation
To assess the incidence of severe hemodynamic and respiratory events of immediate onset
One hour after extubation
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 ".
During stay in the ICU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Société Française d'Anesthésie et de Réanimation

Investigators

  • Study Chair: Jean-Michel CONSTANTIN, MD, Hôpital La Pitié Salpêtrière - Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 22, 2021

Primary Completion (Actual)

March 22, 2022

Study Completion (Actual)

July 12, 2022

Study Registration Dates

First Submitted

July 28, 2021

First Submitted That Met QC Criteria

July 28, 2021

First Posted (Actual)

August 5, 2021

Study Record Updates

Last Update Posted (Actual)

July 18, 2022

Last Update Submitted That Met QC Criteria

July 15, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SAFE-ICU / NR-2021-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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