Evaluation of Nexfin During Anesthesia and in Intensive Care (NexfinEval)

• Sponsor: Hopital Foch (Other)
• Overall Status: Completed
• CT.gov ID: NCT01658631
• Collaborator: (none)
• Enrollment: 97
• Locations: 2
• Duration (Months): 34
• Patients Per Site: 48.5
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Anesthesia	Device: arterial pressure measurement (Nexfin, a noninvasive finger cuff system)

Study Design

• Study Type: Observational
• Actual Enrollment: 97 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Evaluation of Nexfin During Induction of General Anesthesia and in Intensive Care During a Passive Legs Raising Test
• Study Start Date: Aug 1, 2012
• Actual Primary Completion Date: Jun 1, 2015
• Actual Study Completion Date: Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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)

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age >18

• ASA II, III or IV

• weight between 40 and 180 kg; BMI < 35

• normal Allen's test and/or hand Doppler examination.

Exclusion Criteria:

• cardiac arrhythmias,

• history of vascular surgery or vascular implant in the upper limb

• Raynaud disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut Mutualiste Montsouris	Paris		France	75014
2	Hopital Foch	Suresnes		France	92151

Sponsors and Collaborators

• Hopital Foch

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hopital Foch
• ClinicalTrials.gov Identifier: NCT01658631
• Other Study ID Numbers: 2010/42; 2010-A00881-38
• First Posted: Aug 7, 2012
• Last Update Posted: Nov 3, 2016
• Last Verified: Nov 1, 2016

Study Results

No Results Posted as of Nov 3, 2016