Hemodynamic Measurements at Different Inclinations of the... | NCT02046785

Studies
Hemodynamic Measurements at Different Inclinations of the Head

NCT02046785

Sponsor

Federal University of Uberlandia

Status

Unknown status

Last Update Posted

Jan 28, 2014Estimated

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Hypovolemic Shock

Interventions

0.9% saline solution

Countries

Brazil

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

Jan 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2013

Primary Completion Date

Sep 2013Actual

Completion Date

May 2014Estimated

First Submitted Date

Jul 11, 2013

First Submission Date that Met QC Criteria

Jan 24, 2014

First Posted Date

Jan 28, 2014Estimated

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

Jan 24, 2014

Last Update Posted Date

Jan 28, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rosangela de Oliveira Felice, nursing specialist, Federal University of UberlandiaPrincipal Investigator

Lead Sponsor

Federal University of UberlandiaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 determine whether hemodynamic measures vary in angles bedside before and after volume challenge.

Detailed Description

Check if values of central venous pressure (CVP), pulse pressure variation (Δpp), heart rate (HR), mean arterial pressure ((PAM) vary in different angles headboards
Compare values of CVP, Δpp, HR and MAP as predictors of blood volume after supply of 500 ml of 0.9% saline solution.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
0.9% saline solution	Other	comparing values obtained before and after administration of 500 ml of 0.9% saline	Other: 0.9% saline solution

Interventions

Name	Type	Description	Arm Group Labels	Other Names
0.9% saline solution	Other	comparing values obtained before and after administration of 500 ml of 0.9% salin	0.9% saline solution

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Different Backrest position's effect on CVP, CO and ∆PP measures		Data collection was performed at admission or within 10 days of hospitalization between September 2013 and February 2014.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Being in circulatory shock and have at least one of the following criteria to identify loss of tissue perfusion: systolic blood pressure <90 mmHg or need for vasoactive drugs, urine output below 0.5 ml / kg / h.
Being under sedation, assessed by the scale of Richmond agitation and sedation (RASS) -5, mechanically ventilated in volume control mode with tidal volume between 8 to 12 ml/kg, PEEP to 8 cm H2O.
Tue signing the informed consent by legal guardian.

Exclusion Criteria:

Presence cardiac arrhythmias.
Presence of abdominal or thoracic trauma.
Contraindication for passive elevation of the members.
Hypoxia significant PaO2/FiO2 < or equal 100.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rosangela O Felice, Expert	Contact	+553432182258		rosangelafelice@gmail.com

Overall Officials

Name	Affiliation	Role
Rosangela O Felice, expert	Federal University of Uberlandia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Intensive Care Unit, Clinical Hospital, Federal University of Uberlandia	Recruiting	Uberlândia	Minas Gerais	38405-382	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D012769	Shock

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077330	Saline Solution

Ancestor Terms

ID	Term
D000077324	Crystalloid Solutions
D007552	Isotonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations

Browse Leaves

Not provided

Browse Branches

Not provided