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

Centre Hospitalier Universitaire, Amiens

Status: Completed

Conditions: Peroperative; Cardiac Output

Treatments: Device: NEXFIN HD; Device: Intraoperative heart rate measurement (reference method)

Study type: Interventional

Funder types: Other

Identifiers

NCT03114579

PI2014_843_0005

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

Measure of the cardiac output obtained by a reference methode

Other group

Treatment:

Device: Intraoperative heart rate measurement (reference method)

Measurement of cardiac output obtained by NEXFIN HD.

Other group

Treatment:

Device: NEXFIN HD