NCT03451565

Brief Summary

This study aims at describing the systemic arterial hypotension secondary to intraoperative beach chair positioning. This is a non-interventional prospective study. The primary endpoint will be the intraoperative systemic arterial pressure measured at the arm. The secondary endpoints will include postoperative mortality, intensive care admission, post anesthesia care unit length of stay,

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 Feb 2018

Shorter than P25 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

First Submitted

Initial submission to the registry

February 23, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

February 23, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 1, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

April 26, 2018

Status Verified

February 1, 2018

Enrollment Period

11 months

First QC Date

February 23, 2018

Last Update Submit

April 24, 2018

Conditions

Keywords

HypotensionSystemic blood pressure

Outcome Measures

Primary Outcomes (1)

  • Blood pressure

    10 min after surgery

Eligibility Criteria

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

The population studied will include patients operated at the University Hospitals of Strasbourg in a sitting position.

You may qualify if:

  • Age above 18 years
  • Patient operated in a sitting position at Hopitaux Universitaires de Strasbourg
  • Patient willing to participate in the study

You may not qualify if:

  • Refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service D'Anesthesiologie - Reanimation Chirurgicale

Strasbourg, 67098, France

RECRUITING

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Eric Noll, MD

    University Hospital, Strasbourg, France

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

February 23, 2018

First Posted

March 1, 2018

Study Start

February 23, 2018

Primary Completion

February 1, 2019

Study Completion

February 1, 2019

Last Updated

April 26, 2018

Record last verified: 2018-02

Locations