Hemodynamic Measurements at Different Inclinations of the Head

Hypovolemic Shock Clinical Trial

— HMDIH  

Official title:

Comparison of CVP Values , ΔPP and Echocardiographic at Different Angles Headwaters Before and After Volume Challenge

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02046785
• Other study ID #: Hemodinamica
• Status: Recruiting
• Phase: N/A
• First received: July 11, 2013
• Last updated: January 24, 2014
• Start date: April 2013
• Est. completion date: May 2014

Study information

• Verified date: January 2014
• Source: Federal University of Uberlandia
• Contact: Rosangela O Felice, Expert
• Phone: +553432182258
• Email: rosangelafelice[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether hemodynamic measures vary in angles bedside before and after volume challenge.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Hypovolemic Shock

Intervention

Other:
• 0.9% saline solution
comparing values obtained before and after administration of 500 ml of 0.9% salin

Locations

Country	Name	City	State
Brazil	Intensive Care Unit, Clinical Hospital, Federal University of Uberlandia	Uberlandia	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Uberlandia

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes