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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03114579
Recruitment Status : Completed
First Posted : April 14, 2017
Last Update Posted : April 14, 2017
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Cardiac Output Peroperative Device: Intraoperative heart rate measurement (reference method) Device: NEXFIN HD Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of the Measurement of Cardiac Output by the NEXFIN HD Monitor in Peroperative
Actual Study Start Date : February 11, 2015
Actual Primary Completion Date : February 11, 2017
Actual Study Completion Date : February 11, 2017

Arm Intervention/treatment
Measure of the cardiac output obtained by a reference methode 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)

Measurement of cardiac output obtained by NEXFIN HD. Device: NEXFIN HD



Primary Outcome Measures :
  1. Overall survival defines as the time between the date of surgery and death or date of last news [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03114579


Locations
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France
CHU Amiens Picardie
Amiens, Picardie, France, 80054
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT03114579    
Other Study ID Numbers: PI2014_843_0005
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: April 14, 2017
Last Verified: April 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No