NCT03086603

Brief Summary

The study is aimed at observe how spinal anesthesia modifies the hemodynamic state of the patient after optimization to preload independence with a Goal Directed Therapy algorithm guided by non invasive hemodynamic monitoring with Clearsight.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2016

Shorter than P25 for all trials

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

March 1, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2017

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 22, 2017

Completed
Last Updated

March 22, 2017

Status Verified

March 1, 2017

Enrollment Period

2 months

First QC Date

February 28, 2017

Last Update Submit

March 15, 2017

Conditions

HemodynamicsFluid TherapyAnesthesia, SpinalMonitoring, Intraoperative

Outcome Measures

Primary Outcomes (1)

  • stroke volume and stroke volume index

    stroke volume and stroke volume index variation after spinal anesthesia

    duration of spinal anesthesia procedure

Secondary Outcomes (3)

  • cardiac output and cardiac index

    duration of spinal anesthesia procedure

  • peripheral vascular resistance index (SVRI)

    duration of spinal anesthesia procedure

  • episodes of hypotension and hypertension intraoperatively

    duration of surgery

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Thirty patients aged between 50 and 80 years, with an American Society of Anaesthesiologists' (ASA) score 2 or 3 and scheduled for elective primary total hip arthroplasty under spinal anaesthesia. Exclusion criteria were contraindications to neuraxial anaesthesia, peripheral vascular abnormalities (severe vascular diseases, Raynaud's disease, arteriovenous fistula for hemodialysis, previous vascular surgery of the upper arms, advanced diabetes with neuropathy or vascular disease), ASA classes 1, 4 and 5 and patients' refusal.

You may qualify if:

  • scheduled for elective primary hip arthroplasty
  • scheduled for spinal anesthesia
  • American Society of Anaesthesiologists' (ASA) score 2 or 3
  • aged between 50 and 80 years

You may not qualify if:

  • contraindications to neuraxial anaesthesia
  • peripheral vascular abnormalities
  • American Society of Anaesthesiologists' (ASA) score 1, 4 and 5
  • patients' refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

Study Officials

  • Stefano Bonarelli, MD

    Istituto Ortopedico Rizzoli

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

February 28, 2017

First Posted

March 22, 2017

Study Start

March 1, 2016

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

March 22, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)