NICOM-VAL: Validation of Nicom Device to Measure Stoke Volume Variation

• Sponsor: Hopital Foch (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02485457
• Collaborator: (none)
• Enrollment: 2
• Locations: 2
• Arms: 2
• Actual Duration (Months): 23.5
• Patient Per Site: 1
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the ability of NICOM (Noninvasive cardiac output monitor) to detect stroke volume variation induced by leg raising or fluid expansion during surgery

Condition or Disease	Intervention/Treatment	Phase
Anesthesia	Procedure: Volume loading; Drug: Ringer solution	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Diagnostic
• Official Title: Validation of NICOM for the Detection of Modification of Stroke Volume
• Actual Study Start Date: Jun 28, 2015
• Actual Primary Completion Date: Jun 12, 2017
• Actual Study Completion Date: Jun 12, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Low volume The protocol will follow the following steps : basal measurements (heart rate, arterial pressure, stroke volume estimated by esophageal Doppler, stoke volume estimated by Nicom) followed by passive leg rising and additional measurements (heart rate, arterial pressure, stoke volume estimated by esophageal Doppler, stoke volume estimated by Nicom) second basal measurements (heart rate, arterial pressure, stoke volume estimated by esophageal Doppler, stoke volume estimated by Nicom) followed by low volume loading (250 ml of Ringer solution) and additional measurements (heart rate, arterial pressure, stoke volume estimated by esophageal Doppler, stoke volume estimated by Nicom)	Procedure: Volume loading; Volume loading with Ringer Lactate; Drug: Ringer solution
Experimental: High volume The protocol will follow the following steps : basal measurements (heart rate, arterial pressure, stroke volume estimated by esophageal Doppler, stoke volume estimated by Nicom) followed by passive leg rising and additional measurements (heart rate, arterial pressure, stoke volume estimated by esophageal Doppler, stoke volume estimated by Nicom) second basal measurements (heart rate, arterial pressure, stoke volume estimated by esophageal Doppler, stoke volume estimated by Nicom) followed by low volume loading (500 ml of Ringer solution) and additional measurements (heart rate, arterial pressure, stoke volume estimated by esophageal Doppler, stoke volume estimated by Nicom)	Procedure: Volume loading; Volume loading with Ringer Lactate; Drug: Ringer solution

Outcome Measures

Primary Outcome Measures

1. Stroke volume variation [6 hours]

   Stroke volumes measured by esophageal Doppler and by Nicom: at baseline, after leg passive rising, and after volume loading

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• patients undergoing general anesthesia with an expected duration exceeding two hours

• gastrointestinal surgery, urological or gynecological surgery.

Exclusion Criteria:

• Difficulty of venous access.

• Contraindication for the use of oesophageal Doppler

• Contraindication for the use of Nicom

• Contraindication for the use of bispectral index

• Pregnant or lactating women

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Lariboisière	Paris		France	75010
2	Marc Fischler	Paris		France	75015

Sponsors and Collaborators

• Hopital Foch

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hopital Foch
• ClinicalTrials.gov Identifier: NCT02485457
• Other Study ID Numbers: 2014/17
• First Posted: Jun 30, 2015
• Last Update Posted: Jan 29, 2018
• Last Verified: Jan 1, 2018

Study Results

No Results Posted as of Jan 29, 2018