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

Cardiac Output Clinical Trial

— NEXFIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03114579
• Other study ID #: PI2014_843_0005
• Status: Completed
• Phase: N/A
• First received: April 5, 2017
• Last updated: April 13, 2017
• Start date: February 11, 2015
• Est. completion date: February 11, 2017

Study information

• Verified date: April 2017
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: February 11, 2017
• Est. primary completion date: February 11, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Output
• Peroperative

Intervention

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)
• NEXFIN HD

Locations

Country	Name	City	State
France	CHU Amiens Picardie	Amiens	Picardie

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival defines as the time between the date of surgery and death or date of last news		6 months