NCT03186521

Brief Summary

To show that the nurse implementation of a sedation and analgesia algorithm is beneficial to the patient in terms of sedative drugs reduction and thus overall decrease in duration of mechanical ventilation and the morbidity and mortality which is associated with it, without altering patient comfort and tolerance of the environment. This, compared to the less frequent assessments by doctors and thus regular adjustments during the day as opposed to a fixed drug dose.

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
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2014

Typical duration for all trials

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

Study Start

First participant enrolled

December 1, 2014

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

June 9, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 14, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

June 14, 2017

Status Verified

June 1, 2017

Enrollment Period

3 years

First QC Date

June 9, 2017

Last Update Submit

June 13, 2017

Conditions

Sedation

Outcome Measures

Primary Outcomes (1)

  • Duration of mechanical ventilation

    Duration between endotracheale intubation and extubation

    baseline

Eligibility Criteria

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

Mechanically ventilated patients under sedation predicted to last 48hrs or more and aged over 18 years can be included.

You may qualify if:

  • Any patient sedated, intubated, ventilated whose anticipated duration of sedation is more than 48 hours.
  • Age greater than 18 years.

You may not qualify if:

  • Patient under guardianship or \<18.
  • Comatose, intracranial hypertension, brain damage, Acute respiratory distress syndrom, acute severe asthma (therapeutic sedation), Post Cardiac Arrest care, Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

POTTIER

Caen, 14033, France

RECRUITING

Study Officials

  • Véronique POTTIER, MD

    department of anesthesia and intensive care, caen university hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Véronique POTTIER, MD

CONTACT

33231064736pottier-v@chu-caen.fr

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2017

First Posted

June 14, 2017

Study Start

December 1, 2014

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

June 14, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)