Plethysmography Variability Index Monitoring for Parturie... | NCT02614053

Studies
Plethysmography Variability Index Monitoring for Parturients With Antepartum Hemorrhage

NCT02614053

Sponsor

Kasr El Aini Hospital

Status

Unknown status

Last Update Posted

Nov 26, 2015Estimated

Enrollment

124Actual

Phase

Not provided

Conditions

Antepartum Hemorrhage

Interventions

Masimo Radical-7™ Pulse CO-Oximeter

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2015

Primary Completion Date

Nov 2015Estimated

Completion Date

Nov 2015Estimated

First Submitted Date

Nov 23, 2015

First Submission Date that Met QC Criteria

Nov 24, 2015

First Posted Date

Nov 25, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 25, 2015

Last Update Posted Date

Nov 26, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

ahmed elsakka, lecturer of anaesthesia faculty of medicine cairo university, Kasr El Aini HospitalPrincipal Investigator

Lead Sponsor

Kasr El Aini HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the use of continuous noninvasive intraoperative plethesmography variability index in conjunction with Hemoglobin levels monitoring using Masimo Radical-7™ Pulse CO-Oximeter during elective cesarean sections in patients with antepartum and intrapartum hemorrhage as a guide for fluid and blood transfusion practice .

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

124Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Masimo Radical-7™ Pulse CO-Oximeter	Device	a device collecting data regarding PVI, PI & spHB

Measure	Description	Time Frame
Pleth Variability Index		8 months

Measure	Description	Time Frame
hemoglobin level		8 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Anesthesiologist (ASA) Physical status I - II.
patients aged from 18 to 40 years
full-term multigravida parturients
antepartum hemorrhage
singleton fetus

Exclusion Criteria:

Patients with known cardiac problem
peripheral circulatory failure of the upper extremities
significant liver disease
significant renal disease
significant coagulopathy

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

parturients with antepartum hemorrhage admitted for cesarean section

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
nadia yo helmy, md	professor of anaesthesia cairo university	Study Director

Locations

Not provided