NCT01658631

Brief Summary

The purpose of this study is to compare the non invasive measurement of arterial pressure (Nexfin monitor)with the invasive measurement of arterial pressure (radial artery catheter)

  • during induction of general anesthesia,
  • during a leg raising test in the Intensive Care Unit

Trial Health

87
On Track

Trial Health Score

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

Enrollment
97

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2012

Typical duration for all trials

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

August 1, 2012

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 7, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

November 3, 2016

Status Verified

November 1, 2016

Enrollment Period

2.8 years

First QC Date

August 1, 2012

Last Update Submit

November 2, 2016

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Arterial pressure measurement

    Blood pressure will be followed for the duration of induction of anesthesia, an expected average of 20 minutes, or for the passive legs raising test, an expected average of 20 minutes

Study Arms (2)

Anesthesia

Arterial pressure measurement using Nexfin (a noninvasive finger cuff system) during the induction of anesthesia

Device: arterial pressure measurement (Nexfin, a noninvasive finger cuff system)

Intensive Care Unit patients

Arterial pressure measurement using Nexfin (a noninvasive finger cuff system) during a passive legs raising test

Device: arterial pressure measurement (Nexfin, a noninvasive finger cuff system)

Interventions

arterial pressure measurement (Nexfin, a noninvasive finger cuff system)DEVICE
AnesthesiaIntensive Care Unit patients

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 and ICU patients requiring a passive legs raising test

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Institut Mutualiste Montsouris

Paris, 75014, France

Location

Hopital Foch

Suresnes, 92151, France

Location

Related Publications (1)

  • Weiss E, Gayat E, Dumans-Nizard V, Le Guen M, Fischler M. Use of the Nexfin device to detect acute arterial pressure variations during anaesthesia induction. Br J Anaesth. 2014 Jul;113(1):52-60. doi: 10.1093/bja/aeu055. Epub 2014 Apr 25.

    PMID: 24771806DERIVED

Study Design

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

Study Record Dates

First Submitted

August 1, 2012

First Posted

August 7, 2012

Study Start

August 1, 2012

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

November 3, 2016

Record last verified: 2016-11

Locations

FR(2)