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

NCT03114579 | Completed

• 1 other identifier: PI2014_843_0005
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiac Output; Peroperative

Outcome Measures

Primary Outcomes (1)

• Overall survival defines as the time between the date of surgery and death or date of last news

  6 months

Study Arms (2)

Measure of the cardiac output obtained by a reference methode

OTHER

Device: Intraoperative heart rate measurement (reference method)

Measurement of cardiac output obtained by NEXFIN HD.

OTHER

Device: NEXFIN HD

Interventions

Intraoperative heart rate measurement (reference method) DEVICE

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)

Measure of the cardiac output obtained by a reference methode

NEXFIN HD DEVICE

Measurement of cardiac output obtained by NEXFIN HD.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens Picardie

Amiens, Picardie, 80054, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2017
• First Posted: April 14, 2017
• Study Start: February 11, 2015
• Primary Completion: February 11, 2017
• Study Completion: February 11, 2017
• Last Updated: April 14, 2017

Record last verified: 2017-04

Locations

FR (1)