Evaluation of the Measurement of Cardiac Output by the NEXFIN HD Monitor in Peroperative (NEXFIN)

Continuous perioperative cardiac output (DC) and blood pressure (PA) monitoring contributes to hemodynamic stability and ensures adequate perfusion pressure, resulting in a reduction in morbidity and mortality and length of hospital stay.

The monitors usually used in perioperative are either semi-invasive and difficult for calibration (oesophageal Doppler) or invasive (arterial catheter).

The Nexfin HD allows these two measurements and it is completely non-invasive, remains to validate its use in peroperative.

Study Overview

• Status: Completed
• Conditions: Cardiac Output; Peroperative
• Intervention / Treatment: Device: Intraoperative heart rate measurement (reference method); Device: NEXFIN HD

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Picardie
    • Amiens, Picardie, France, 80054
      • CHU Amiens Picardie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult patients candidate for surgery under general anesthesia requiring oesophageal Doppler or arterial catheter hemodynamic monitoring.

Exclusion Criteria:

• Patients with cardiac and thoracic surgery,
• patients for whom access to the head is impossible,
• facial trauma patients,
• patients with aortic malformation, dilation or coarctation,
• patients with aortic dissection,
• patients with vascular surgery with aortic clamping,
• patients with a tumor, stenosis or varices of the esophagus,
• patients with severe oesophagitis,
• patients with thoracic radiotherapy
• patients under guardianship or curatorship or deprived of liberty.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Measure of the cardiac output obtained by a reference methode	Device: Intraoperative heart rate measurement (reference method); Measurement of cardiac output by both monitors: NEXFIN HD and oesophageal doppler, blood pressure measurement by the catheter and NEXFIN HD monitor, and cardiac output and blood pressure measurements after treatment administration (vasoconstrictor or filling)
Other: Measurement of cardiac output obtained by NEXFIN HD.	Device: NEXFIN HD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall survival defines as the time between the date of surgery and death or date of last news	6 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2015
• Primary Completion (Actual): February 11, 2017
• Study Completion (Actual): February 11, 2017

Study Registration Dates

• First Submitted: April 5, 2017
• First Submitted That Met QC Criteria: April 13, 2017
• First Posted (Actual): April 14, 2017

Study Record Updates

• Last Update Posted (Actual): April 14, 2017
• Last Update Submitted That Met QC Criteria: April 13, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: PI2014_843_0005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No