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

NCT ID: NCT03114579

Last Updated: 2017-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-11

Study Completion Date

2017-02-11

Brief Summary

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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

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Conditions

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Cardiac Output Peroperative

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Measure of the cardiac output obtained by a reference methode

Group Type OTHER

Intraoperative heart rate measurement (reference method)

Intervention Type 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)

Measurement of cardiac output obtained by NEXFIN HD.

Group Type OTHER

NEXFIN HD

Intervention Type DEVICE

Interventions

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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)

Intervention Type DEVICE

NEXFIN HD

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Amiens Picardie

Amiens, Picardie, France

Site Status

Countries

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France

Other Identifiers

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PI2014_843_0005

Identifier Type: -

Identifier Source: org_study_id

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