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

• Sponsor: Centre Hospitalier Universitaire, Amiens (Other)
• Overall Status: Completed
• CT.gov ID: NCT03114579
• Collaborator: (none)
• Enrollment: 42
• Location: 1
• Arms: 2
• Actual Duration (Months): 24
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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: Feb 11, 2015
• Actual Primary Completion Date: Feb 11, 2017
• Actual Study Completion Date: Feb 11, 2017

Arms and Interventions

Arm	Intervention/Treatment
Other: 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)
Other: Measurement of cardiac output obtained by NEXFIN HD.	Device: NEXFIN HD

Outcome Measures

Primary Outcome Measures

1. Overall survival defines as the time between the date of surgery and death or date of last news [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Amiens Picardie	Amiens	Picardie	France	80054

Sponsors and Collaborators

• Centre Hospitalier Universitaire, Amiens

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire, Amiens
• ClinicalTrials.gov Identifier: NCT03114579
• Other Study ID Numbers: PI2014_843_0005
• First Posted: Apr 14, 2017
• Last Update Posted: Apr 14, 2017
• Last Verified: Apr 1, 2017

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

Study Results

No Results Posted as of Apr 14, 2017