NCT04654273

Brief Summary

Measuring bedside occlusion pressure in neurosurgical or surgical critically ill patients could tell us about the patient's respiratory drive, and therefore, tell us whether or not extubation will be successful.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
152

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

November 29, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

November 30, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 4, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

July 8, 2021

Status Verified

January 1, 2021

Enrollment Period

1.1 years

First QC Date

November 29, 2020

Last Update Submit

July 7, 2021

Conditions

Respiratory Failure

Outcome Measures

Primary Outcomes (1)

  • Number of re-intubations after extubation

    7 days

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients hospitalized in surgical or neurosurgical intensive care units of CHU de Poitiers, under mechanical ventilation for more than 48 hours, meeting the criteria for severability.

You may qualify if:

  • Age ≥ 18 years old,
  • Hospitalized in surgical or neurosurgical intensive care units
  • Patients under mechanical ventilation for more than 48 hours,
  • Meeting the criteria for severability (spontaneous ventilation test),
  • Free subject, without tutorship or curatorship or subordination,
  • Patients benefiting from a Social Security scheme or benefiting through the intermediary of a third party,
  • No objection given by the patient and / or relative after clear and fair information about the study.

You may not qualify if:

  • Tracheostomized patients,
  • Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social establishment, adults under legal protection,
  • Pregnant and / or lactating women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU POitiers

Poitiers, 86000, France

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Central Study Contacts

Damien MARIE, Dr

CONTACT

05.49.44.15.65damien.marie@chu-poitiers.fr

Study Design

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

Study Record Dates

First Submitted

November 29, 2020

First Posted

December 4, 2020

Study Start

November 30, 2020

Primary Completion

December 31, 2021

Study Completion

January 31, 2022

Last Updated

July 8, 2021

Record last verified: 2021-01

Locations

FR(1)