NCT00700869

Brief Summary

The purpose of this study is to determine if a weaning strategy from artificial ventilation governs by respiratory behaviour status assessed by our method is safe enough.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2008

Typical duration for phase_2

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

April 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 19, 2008

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

October 5, 2011

Status Verified

September 1, 2011

Enrollment Period

3.4 years

First QC Date

June 18, 2008

Last Update Submit

October 4, 2011

Conditions

Artificial RespirationConsciousness DisordersWearing Off Effect

Keywords

Altered level of consciousnessTracheal tube withdrawalRespirationArtificial RespirationPhysiology

Outcome Measures

Primary Outcomes (1)

  • Rate of successful mechanical ventilation weaning at 72 hours

    72 hours

Secondary Outcomes (2)

  • Post tracheal tube withdrawal pneumonia at 72 hours

    72 hours

  • Rate of auto-extubation during patient's participation to the protocol

    10 days

Study Arms (1)

1

EXPERIMENTAL

Tracheal tube withdrawal governs by respiratory behaviour status

Procedure: mechanical ventilation

Interventions

mechanical ventilationPROCEDURE

mechanical ventilation

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Altered level of consciousness (-1 \< RASS \> +1)
  • Mechanical ventilation ( \> 72 hours)
  • Withdrawal of sedative drugs (\> 48 hours)
  • T tube challenge tolerance
  • Signed approval for the study by close relative or legal representative

You may not qualify if:

  • Respiratory disease prior to the actual artificial ventilation requirement.
  • Impairment of upper airway function prior to the actual artificial ventilation requirement.
  • Pregnancy
  • Minor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anesthesia and CCM; Lariboisière Hospital

Paris, 75010, France

Location

MeSH Terms

Conditions

Consciousness DisordersRespiratory Aspiration

Interventions

Respiration, Artificial

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersRespiration DisordersRespiratory Tract DiseasesPathologic Processes

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsResuscitationEmergency TreatmentRespiratory Therapy

Study Officials

  • Laurent HEYER, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2008

First Posted

June 19, 2008

Study Start

April 1, 2008

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

October 5, 2011

Record last verified: 2011-09

Locations

FR(1)