Back to resultsEvaluation of NEXFIN During Cesarean Delivery to Detect Hypotension (NEXFIN-CESAR)
Primary Purpose
Hypotension
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Nexfin
Sponsored by
About this trial
This is an interventional diagnostic trial for Hypotension focused on measuring Hypotension, Cesarean delivery
Eligibility Criteria
Inclusion Criteria:
- adult patients undergoing elective cesarean delivery performed under spinal anesthesia
Exclusion Criteria:
- patients with a heart rhythm disorder, Raynaud's disease or a history of vascular surgery of the upper limb
Sites / Locations
- Institut Hospitalier Franco-Britannique
- Hopital Foch
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Measurement of arterial pressure
Arm Description
Outcomes
Primary Outcome Measures
Comparison between Nexfin and intermittent measurements of blood pressure
Bland and Altman analysis (bias and limits of agreement). Analysis concerns data from intrathecal injection to childbirth
Secondary Outcome Measures
Area under the curve between both measurements
Analysis concerns data from intrathecal injection to childbirth
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01732133
Brief Title
Evaluation of NEXFIN During Cesarean Delivery to Detect Hypotension
Acronym
NEXFIN-CESAR
Official Title
Evaluation of the System NEXFIN for Continuous and Non-invasive Measure of the Blood Pressure During Cesarean Delivery Practised Under Spinal Anesthesia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
April 2013 (Actual)
Primary Completion Date
January 22, 2016 (Actual)
Study Completion Date
January 22, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Foch
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Hypotension after spinal anesthesia for cesarean delivery occurs frequently. Oscillometric measurement gives intermittent informations. Nexfin, a continuous noninvasive device, could help to detect hypotension.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension
Keywords
Hypotension, Cesarean delivery
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
171 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Measurement of arterial pressure
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Nexfin
Other Intervention Name(s)
Continuous measurement of arterial pressure using Nexfin
Primary Outcome Measure Information:
Title
Comparison between Nexfin and intermittent measurements of blood pressure
Description
Bland and Altman analysis (bias and limits of agreement). Analysis concerns data from intrathecal injection to childbirth
Time Frame
two years
Secondary Outcome Measure Information:
Title
Area under the curve between both measurements
Description
Analysis concerns data from intrathecal injection to childbirth
Time Frame
two years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult patients undergoing elective cesarean delivery performed under spinal anesthesia
Exclusion Criteria:
patients with a heart rhythm disorder, Raynaud's disease or a history of vascular surgery of the upper limb
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Fischler, MD
Organizational Affiliation
Hopital Foch
Official's Role
Study Chair
Facility Information:
Facility Name
Institut Hospitalier Franco-Britannique
City
Levallois
ZIP/Postal Code
92300
Country
France
Facility Name
Hopital Foch
City
Suresnes
ZIP/Postal Code
92151
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
34087863
Citation
Bobet M, Joachim J, Gayat E, Bonnet A, Sievert K, Barnichon C, Fischler M, Le Guen M. Blood pressure measurement during cesarean delivery: Evaluation of a beat-to-beat noninvasive device (NexfinTM). Medicine (Baltimore). 2021 Jun 4;100(22):e26129. doi: 10.1097/MD.0000000000026129.
Results Reference
derived
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Evaluation of NEXFIN During Cesarean Delivery to Detect Hypotension
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