NCT04992117

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
633

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 22, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 5, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2022

Completed
Last Updated

July 18, 2022

Status Verified

July 1, 2022

Enrollment Period

1 year

First QC Date

July 28, 2021

Last Update Submit

July 15, 2022

Conditions

Unplanned ExtubationSelf Extubation

Keywords

Self extubationUnplanned extubationintensive care unit

Outcome Measures

Primary Outcomes (1)

  • Quantitative description

    Quantitative description of unscheduled extubation episodes in intensive care unit

    During stay in the ICU

Secondary Outcomes (4)

  • Qualitative description

    During stay in the ICU

  • re-intubation

    During stay in the ICU

  • Severe hemodynamic and respiratory events

    One hour after extubation

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

    During stay in the ICU

Study Arms (1)

Unplanned-extubation in the ICU

Patients with unplanned extubation in the ICU

Other: NO INTERVENTION

Interventions

NO INTERVENTIONOTHER

NO INTERVENTION

Unplanned-extubation in the ICU

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital La Pitié Salpêtrière- Département d'Anesthésie-Réanimation

Paris, France

Location

Study Officials

  • Jean-Michel CONSTANTIN, MD

    Hôpital La Pitié Salpêtrière - Paris

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2021

First Posted

August 5, 2021

Study Start

March 22, 2021

Primary Completion

March 22, 2022

Study Completion

July 12, 2022

Last Updated

July 18, 2022

Record last verified: 2022-07

Locations

FR(1)