NCT01032226

Brief Summary

The purpose of this study is to compare

  • the non invasive measurement of arterial pressure (CNAP monitor)
  • with the invasive measurement of arterial pressure (radial artery catheter) during induction and maintenance of general anesthesia

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2009

Geographic Reach
1 country

1 active site

Status
terminated

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

December 1, 2009

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

December 12, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 15, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

September 23, 2016

Status Verified

September 1, 2016

Enrollment Period

1.2 years

First QC Date

December 12, 2009

Last Update Submit

September 22, 2016

Conditions

General Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Comparison between both methods of arterial pressure measurement

    intraoperative

Eligibility Criteria

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

Patients undergoing major surgery with the need for an invasive blood pressure measurement

You may qualify if:

  • Age \>18
  • ASA II, III or IV
  • weight between 40 and 180 kg; BMI \< 35
  • surgical procedure performed in supine position
  • normal Allen's test and hand Doppler examination.

You may not qualify if:

  • cardiac arrhythmias,
  • history of vascular surgery or vascular implant in the upper limb

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Foch

Suresnes, 92151, France

Location

Study Officials

  • Marc Fischler, MD

    Hôpital Foch

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

December 12, 2009

First Posted

December 15, 2009

Study Start

December 1, 2009

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

September 23, 2016

Record last verified: 2016-09

Locations

FR(1)