NCT02979652

Brief Summary

This study is done to estimate prevalence of the main detectable lung and cardiovascular complications by an ultrasound realized in room of post-interventional supervision at the patients whose duration of general anesthesia is superior at one hour after a surgery to risk

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
325

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2016

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

April 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

December 1, 2016

Status Verified

November 1, 2016

Enrollment Period

1.6 years

First QC Date

November 24, 2016

Last Update Submit

November 30, 2016

Conditions

Intensive Care, Surgical

Outcome Measures

Primary Outcomes (1)

  • cardiac and pulmonary functions

    cardiac and pulmonary functions will be evaluated by cardiac and pulmonary ultrasound exams for all patient whom have a more than 1 hour surgical intervention

    1 hour

Eligibility Criteria

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

patients hospatilized for a major surgery

You may qualify if:

  • Physical status score \> 1
  • Anesthesia of duration \> 1 hour
  • Visceral, orthopaedic, vascular, thoracic surgery, neurosurgery

You may not qualify if:

  • Technical incapacity of accessibility to the ultrasound window
  • Cardiac or pulmonary transplant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departement anesthesie reanimation hopital nord

Marseille, 13015, France

RECRUITING

Study Officials

  • Marc Leone, MD

    Departement anesthesie reanimation hopital nord

    STUDY DIRECTOR

Central Study Contacts

Marc Leone, M.D

CONTACT

mleone@ap-hm.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
8 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2016

First Posted

December 1, 2016

Study Start

April 1, 2016

Primary Completion

November 1, 2017

Study Completion

January 1, 2018

Last Updated

December 1, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)