NCT02202122

Brief Summary

Interest of the four major OSA Predictive Scores (STOP-BANG, P-SAP, DES-OSA, OSA50) in the prognosis of postoperative mortality after femoral neck fracture.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
withdrawn

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

July 25, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 28, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

June 23, 2015

Status Verified

June 1, 2015

Enrollment Period

1.1 years

First QC Date

July 25, 2014

Last Update Submit

June 22, 2015

Conditions

Femoral Neck Fracture

Keywords

Femoral Neck FracturesObstructive Sleep ApneaPerioperative Complications

Outcome Measures

Primary Outcomes (1)

  • Impact OSA predictive scores on mortality prognosis

    Impact of the four major OSA predictive scores (STOP-BANG, P-SAP, OSA50 et DES-OSA) on the mortality prognosis after surgery for femoral neck fracture

    1 month

Study Arms (1)

Study Group

OSA Scoring

Other: OSA Scoring

Interventions

OSA ScoringOTHER

Comparison of the preoperative OSA scoring (STOP-BANG, DES-OSA, P-SAP and OSA50) with the postoperative mortality at one month.

Study Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients with femoral neck fractures

You may qualify if:

  • All patients with femoral neck fractures
  • Incoming at the Saint-Luc Bouge Hospital
  • Between 15/09/2014 and 15/10/2015

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique Saint-Luc de Bouge

Namur, Namur, 5100, Belgium

Location

MeSH Terms

Conditions

Femoral Neck FracturesSleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Hip FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesSleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Eric P Deflandre, MD, FCCP

    Astes

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Eric DEFLANDRE, MD, FCCP

Study Record Dates

First Submitted

July 25, 2014

First Posted

July 28, 2014

Study Start

September 1, 2014

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

June 23, 2015

Record last verified: 2015-06

Locations

BE(1)