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

Not Applicable

Completed

• Conditions: Peroperative; Cardiac Output
• Interventions: Device: NEXFIN HD; Device: Intraoperative heart rate measurement (reference method)

• Registration Number: NCT03114579
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-11
• Primary Completion: 2017-02-11
• Study Completion: 2017-02-11
• Status Verified: 2017-04
• Study First Submitted: 2017-04-05
• Study First Submitted QC: 2017-04-13
• Last Update Submitted: 2017-04-13
• Study First Posted: 2017-04-14
• Last Update Posted: 2017-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Measurement of cardiac output obtained by NEXFIN HD.	NEXFIN HD	-
Measure of the cardiac output obtained by a reference methode	Intraoperative heart rate measurement (reference method)	-

Primary Outcome Measures

Name	Time	Method
Overall survival defines as the time between the date of surgery and death or date of last news	6 months

Trial Locations

Locations (1)

CHU Amiens Picardie; 🇫🇷 Amiens, Picardie, France